Acceptable Daily Intakes for Agricultural and Veterinary Chemicals

1. Preface

This document sets out the acceptable daily intakes (ADIs) for agricultural and veterinary (agvet) chemicals used on food producing crops or animals. It includes entries which were recommended by the former Pesticides and Agricultural Chemicals Standing Committee (PACSC) of the National Health and Medical Research Council (NHMRC) until November 1992. The responsibility for establishing ADIs transferred to the Australian Department of Health on 12 March 1993. On 1 July 2016, the task of establishing ADIs was transferred to the Australian Pesticide and Veterinary Medicines Authority (APVMA). 

ADIs which had been established by all previous Australian authorities are included in this document provided the agvet chemical is currently approved for use in food producing animals or crops. Agvet chemicals which are no longer approved for use by the APVMA have been removed. However, where persistent residues of agvet chemicals which are no longer approved may sporadically be detected in some crops, a Tolerable Daily Intake (with the same numerical value as the original ADI) is included in the table as a reference. An ADI is usually only established for agvet chemicals which are intentionally used in food producing crops, animals or crops used for stock feed. In this table the term TDI is reserved for agvet chemicals which are no longer intentionally used in food producing animals or crops.

2. Introduction

Over the past several decades agricultural and veterinary (agvet) chemicals have become an important factor in food production. The availability of these chemicals has enabled significant increases in agricultural productivity to be achieved.

While the consumption of agvet chemicals is not desirable in itself, ingestion of these substances in the form of residues in agricultural produce may occur as a consequence of their intended use. Residues resulting from proper agricultural use are either very low or not detected as has been consistently demonstrated in several Australian Total Diet Studies. Australian Total Diet Studies, previously known as Australian Market Basket Surveys, are a comprehensive assessment of consumers’ dietary exposure (intake) to pesticide residues, contaminants and other substances.  Australian Total Diet Studies are undertaken by Food Standards Australia New Zealand (FSANZ) approximately every two years and involve purchasing food from local stores in each State of Australia and preparing them to a ‘table ready’ state before they are analysed. As a consequence, both raw and cooked foods (e.g. potatoes) are examined. Results of completed Australian Total Diet Studies are available on the FSANZ website.

Prior to the registration of an agvet chemical product applicants are required to provide the APVMA with relevant information, such as toxicological studies, to support the safe use of a product. Toxicological studies required for agricultural and veterinary chemicals range from those measuring single dose effects to those which examine the effects of lifetime exposure. Toxicity studies are generally performed in laboratory animals, such as rats and rabbits, and are designed to identify potential toxic effects which may be important for humans. The studies usually involve the feeding/administration of various levels of the compound under investigation to animals, followed by observation and monitoring of clinical parameters and pathology which are indicative of toxicity in the test species. The range of toxicological studies usually undertaken is described under ‘Data guidelines’ which are available on the APVMA website.

The immediate hazard from a chemical is determined by identifying the acute toxicity by the most likely routes of exposure, together with tests for skin and eye irritation and skin sensitisation. The potential for toxicity over longer periods, including possible tumour induction, is determined by studying the effects of repeated dosing, in some cases for the entire lifespan of the species. Multi-generation and developmental studies predict reproductive toxicity and the potential to cause birth defects, and studies are performed to assess the potential to cause effects on genetic material. Other specific investigations also may be required to clarify the mechanism of toxicity of a particular chemical.

Designs for the conduct of toxicological studies have become standardised to a large extent and international guidelines have been developed to achieve consistency in experimental techniques. In general, groups of the test species/organism are exposed to a number of dose levels (usually three) of the substance and a further group is left unexposed (control group). The treatment levels are selected so that the highest dose will cause some obvious toxic effects, while the lowest dose at least, should not result in a toxic effect. These toxicological studies are assessed with a view to determining the potential hazards associated with exposure to the chemical. Assessment of individual toxicity studies includes the determination of a no-observed-adverse-effect level (NOAEL), which is the highest administered dose which does not cause any detectable (usually adverse) effect in the study. The overall NOAEL for a chemical, determined in the most sensitive species, is then used to estimate the acceptable daily intake.

The ADI for humans is considered to be a level of intake of a chemical that can be ingested daily over an entire lifetime without any appreciable risk to health. It is calculated by dividing the overall NOAEL from the animal studies by an uncertainty (safety) factor. The magnitude of the uncertainty factor is intended to account for uncertainties in extrapolating animal data to humans, variation between humans and completeness of the toxicological database.

The most common uncertainty (or safety) factor is 100 which takes into account that humans may be 10 times more sensitive to the chemical than laboratory animals and that a proportion of the population may be 10 times more sensitive than the average person. Where there is satisfactory information in humans, there is no necessity to extrapolate from animal data and an uncertainty factor of 10 is considered adequate to account for inter-individual variation. On the other hand when the toxicity data base is incomplete or when the nature of the potential hazard indicate the need for additional caution, an additional uncertainty factor of 10 to 20 may be incorporated. In these situations, the overall NOAEL is divided by a safety factor of 1000 to 2000 in determining the ADI.

It is important to note that the toxicological studies on which the overall NOAEL is based are invariably carried out by oral dosing of laboratory animals and usually by incorporation of the chemical in the diet. The subsequent establishment of an ADI is thus directed to human exposure by the oral route. Due to likely differences in absorption and other kinetic and metabolic parameters, the comparison of exposure by non-oral routes with the ADI should be interpreted with caution.

3. Notes

  1. Use of the terms JMPR or JECFA in the no-observed-adverse-effect-level (NOAEL) column indicates that the Australian ADI has been adopted from the figure established by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) or the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
  2. (H) indicates that the NOAEL was determined on the basis of experimental data in humans.
  3. (LOAEL) indicates that no NOAEL has been identified in a pivotal study.
  4. The words "not specified" in the ADI column indicates that there is a large margin of safety for consumption of residues in food when the chemical is used according to good agricultural/veterinary practice. Due to low levels of residues and the lack of oral activity of these chemicals, a numerical ADI is not considered necessary.
  5. (M) indicates that the ADI is derived from microbiological data.
  6. TDI means Tolerable Daily Intake. ADIs are not maintained for those agricultural and veterinary chemicals that are no longer permitted for use in agricultural practice. However, residues of certain environmentally persistent pesticides may occur as residues in agricultural commodities as a consequence of past use. In these cases, health intake values are maintained as Tolerable Daily Intake values, to serve as a guideline with which potential dietary intakes of these environmentally persistent chemicals can be compared.

This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Public Affairs and Communication Branch, Australian Pesticide and Veterinary Medicines Authority, PO Box 6182, Kingston, ACT, 2604, or email media@apvma.gov.au.

This document includes recommendations made by the former Pesticides and Agricultural Chemicals Standing Committee (PACSC) of the National Health and Medical Research Council (NHMRC) and by the Office of Chemical Safety (OCS).

© Commonwealth of Australia 2017

ISSN 1446-1412

Any comments or enquiries relating to the entries in this document should be addressed to:

Australian Pesticide and Veterinary Medicines Authority
18 Wormald Street
Symonston ACT 2609

View our copyright information.

5. Printable version

View a printable PDF version of the ADI list.

6. Alpha list of chemicals

Chemical

ADI (mg/kg bw/d)

NOAEL (mg/kg bw/d)

Date

Study

Comments

A

Abamectin

0.005

0.5

10 November 1999

3–week developmental rabbit study; a NOAEL of 0.5 mg/kg bw/d was based on observed teratogenicity at the next higher dose (1 mg/kg bw/d).

ARfD established for acute developmental effects.

Acephate

0.003

0.22

10 February 1988

   

Acetamiprid

0.1

9

27 July 2001

2–year dietary rat study; a NOAEL of 9 mg/kg bw/d was based on reductions in bodyweight gain and food consumption, increased incidence of hepatocellular hypertrophy and vacuolation observed in the liver at the next higher dose.

 

Acetyl isovaleryltylosin tartrate

0.0001

0.031 (MIC50)

21 August 2006

A microbiological ADI of 0.0001 mg/kg bw/d was based on a MIC50 of 0.031 microgram/ml in the most sensitive bacterial genus, (Bifidobacterium) found in the human GI tract.

 

Acibenzolar-S-methyl

0.005

5 [LOAEL]

23 April 2002

1–year dietary dog study; based on haematological changes associated with anaemia observed at the LOAEL of 5 mg/kg bw/d.

 

Acifluorfen

0.01

1

15 September 1999

2–year dietary mouse study; a NOAEL of 1 mg/kg bw/d was based on increases in liver weight and plasma enzymes (ALT, AST, AP), with adrenal degeneration observed at the next higher dose. This NOAEL was supported by a 2–year dietary rat study; a NOAEL of 1.2 mg/kg bw/d was based myocardial degeneration with fibrosis in the liver and heart at the next higher dose.

 

Acrolein

0.0005

0.05

15 March 1994

2–year gavage rat study; a NOAEL of 0.05 mg/kg bw/d was based on mortality and serum biochemical effects at the next higher dose.

 

Albendazole

0.05

5

9 August 1994

Developmental rat study; a NOAEL of 5 mg/kg bw/d was based on reduced size and weight, delayed ossification, increased incidences of micromelia and microfetalis at the next higher dose. This NOAEL was supported by a 6– month dog (capsule) study; a NOAEL of 5 mg/kg bw/d was based on hypocellularity of the sternum at higher doses.

 

Aldicarb

0.001

0.01 (H)

15 December 1999

Single dose human study; a NOAEL of 0.01 mg/kg bw/d was based on plasma and RBC ChE inhibition at the next higher dose.

 

Aldrin

0.0001 (TDI)

JMPR'94

21 October 2003

 

Tolerable daily intake. Traditional ADI not maintained as aldrin is no longer used in agricultural practice and does not have industrial sponsors. Numerical tox. End-point maintained to serve as a guideline with which potential dietary intakes can be compared.

Alpha-cypermethrin

0.05

4.7

11 March 1994

13–week dog study; a NOAEL of 4.7 mg/kg bw/d was based on ataxia, body tremors, agitation and abnormal gait at the next higher dose.

 

Altrenogest

0.000002

0.004

13 August 1992

   

Ametoctradin

10

1000

1 February 2012

2–year studies in rats and mice showed no adverse effects at the highest tested dose of 1000 mg/kg bw/d.

 

Ametryn

0.02

2

17 November 1989

2–gen reproduction rat study; a NOAEL of 2 mg/kg bw/d was based on a reduction in body weight and body weight gain at the next higher dose.

 

Aminoethoxyvinylglycine

0.0002

0.2

28 September 2000

3–month dietary rat study; a NOAEL of 0.2 mg/kg bw/d was based on a reduction in blood AST activity at the next higher dose.

 

Aminopyralid

0.3

26

28 September 2005

Developmental rabbit study; a NOAEL of 26 mg/kg bw/d was based on transient incoordination in dams at the next higher dose

 

Amisulbrom

0.1

11

14 June 2016

1–year rat dietary study; a NOAEL of 11 mg/kg/d was based on increased incidence and severity in bile duct hyperplasia at the next higher dose. 18–month dietary mouse study; a NOAEL of 11 mg/kg/d was based on increased relative liver weight and hepatocellular adenoma at the next higher dose.

 

Amitraz

0.002

0.25

5 November 1986

2–year oral (gelatin capsule) dog study; a NOAEL of 0.25 mg/kg bw/d was based on elevated blood glucose at the next higher dose.

 

Amitrole

0.0003

0.025

3 May 1984

   

Amoxycillin

0.2

200

8 March 1995

   

Apramycin

0.05

5

29 May 1986

   

Asulam

0.02

40

December 1985

   

Atrazine

0.005

0.5

1 December 1996

2–year dietary rat study; a NOAEL of 0.5 mg/kg bw/d was based on mammary tumours in females at the next higher dose.

 

 

Aureobasidium pullulans

 

 

21 February 2017

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Avilamycin

1

108

19 December 1997

2–year dietary rat study; a NOAEL of 108 mg/kg bw/d was based on absence of any observed toxicity at the highest tested dose.

 

Azafenidin

0.0004

0.04

4 July 2001

3–month dietary dog study; a NOAEL of 0.04 mg/kg bw/d was based on porphyrin and pigment accumulation in the liver and other liver toxicity at the next higher dose.

 

Azamethiphos

0.003

0.25

29 May 1996

1–year dietary dog study; a NOAEL of 0.25 mg/kg bw/d was based on inhibition of plasma, RBC and brain cholinesterase activity at the next higher dose.

 

Azaperone

0.1

10

5 August 1983

   

Azimsulfuron

0.2

18

9 September 2002

1–year dietary dog study; a NOAEL of 18 mg/kg bw/d was based on reduced bodyweight gain and brown pigment deposition the liver at the next higher dose.

 

Azinphos-methyl

0.025

0.25 (H)

26 August 2002

28–day repeat-dose human study; a NOAEL of 0.25 mg/kg bw/d was based the absence of any inhibition of plasma or RBC ChE at 0.25 mg/kg bw/d, the only dose tested.

 

Azoxystrobin

0.1

10

29 September 1998

3–month oral (gelatin capsule) dog study; a NOAEL of 10 mg/kg bw/d was based on reduced body weights, increased salivation and vomiting at the next higher dose.

 

B

Bacillus licheniformis

 

 

9 May 2002

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bacillus sphaericus strain 2362

 

 

9 May 2003

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bacillus subtilis

 

 

9 May 2002

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bacillus thuringiensis

   

6 September 2002

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bacillus thuringiensis subsp. thuringiensis serotype 1 (strain MPPL 002)

   

28 August 2003

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Bacitracin

0.1

10

26 May 1997

Developmental rat study; a NOAEL of 75 mg/kg bw/d Albac (10 mg/kg bw/d bacitracin) was based on increased salivation and reduced body weight gain at the next higher dose.

An uncertainty (safety) factor of 100 was considered appropriate due to the poor gastrointestinal absorption of bacitracin.

Bambermycin

0.3

29

14 September 2001

2–year dietary rat study; a NOAEL of 29 mg/kg bw/d was based on increased kidney and liver weight at the next higher dose.

Previously named:flavophospholipol

Benalaxyl

0.05

5

1 December 1988

   

Bendiocarb

0.004

0.4

8 June 1993

Reproduction rat study; a NOAEL of 0.4 mg/kg bw/d was based on reduced maternal weight gain at the next higher dose.

 

Benfluralin

0.05

5

18 February 1987

   

Bensulfuron-methyl

0.02

2.5

10 September 1987

   

Bensulide

0.04

4

4 February 1982

   

Bentazone

0.1

10

10 June 2005

2–year dietary rat study; a NOAEL of 10 mg/kg bw/d was based on decreased food consumption, associated reduced body weight gain and altered absolute and relative kidney, brain, heart, liver and spleen weights at the next higher dose.

 

Benzofenap

0.004

0.4

27 March 1998

2–gen reproduction rat study; a NOAEL of 0.4 mg/kg bw/d was based on reduced pup survival at the next higher dose.

 

Benzylpenicillin procaine

0.03 mg/person/d

 

10 October 2016

Long history of safe use in human medicine.

In the absence of adequate data to establish a NOAEL, JECFA recommended that the daily intake from food be kept as low as practicable (JECFA-99; H).

6-Benzyladenine

0.02

30

15 August 1979

   

Beta-cyfluthrin

0.01

1.5

5 December 1990

13–week dietary dog study; a NOAEL of 1.5 mg/kg bw/d was based on vomiting, diarrhoea and effects on motor function at the next higher dose.

 

Beta-cypermethrin

0.05

5

19 March 2002

2–year dietary rat study; based on a NOAEL for cypermethrin.

The 2–year rat study used for establishing the cypermethrin ADI was considered appropriate to use for the beta-cypermethrin ADI as all the isomers contained in beta-cypermethrin are contained in cypermethrin.

Bicyclopyrone

0.001

0.28

26 November 2015

1–year dietary rat study; a NOAEL of 0.28 mg/kg bw/d was based on increased kidney weight, chronic progressive nephropathy and thyroid follicular hyperplasia, along with changes in urine clinical chemistry parameters, corneal opacity and corneal damage at the next higher dose.

 

Bifenazate

0.01

1

12 December 2002

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on reduced bodyweight gain at the next higher dose. 1–year dietary dog study; a NOAEL of 1 mg/kg bw/d was based on reduced bodyweight gain, haematological and clinical chemistry effects, urine changes, organ weight changes and histopathological effects at the next higher dose.

 

Bifenthrin

0.01

1

26 November 1992

Developmental rat study; a NOAEL of 1 mg/kg bw/d was based on maternal tremors at the next higher dose.

 

Bioresmethrin

0.03

3

20 June 1991

2–year dietary rat study; a NOAEL of 3 mg/kg bw/d was based on hepatotoxicity at the next higher dose.

 

Bitertanol

0.01

1

15 November 1982

   

Bixafen

0.02

2

18 January 2016

2–year dietary rat study; a NOAEL of 2.0 mg/kg bw/d was based on increased liver weight and thyroid effects (higher incidence and/or severity of colloid alteration) at the next higher dose.

 

Boscalid

0.06

6

15 August 2003

2–year dietary rat study; a NOAEL of 6 mg/kg bw/d was based on clinical signs at the next higher dose.

 

Brodifacoum

0.0000005 (TDI)

0.001

16 May 1990

13–week dietary rat study; a NOAEL of 0.001 mg/kg bw/d was based on prolonged blood clotting (prothrombin) time at the next higher dose.

Tolerable daily intake. An ADI was not established as brodifacoum residues are not expected to be present in the food supply. A TDI is maintained to serve as a guideline with which potential dietary exposure assessments can be undertaken in the event of unintentional presence.

Bromacil

0.1

10

10 February 1988

   

Bromadiolone

0.000002 (TDI)

0.004

18 January 1994

Developmental rabbit study; a NOAEL of 0.004 mg/kg bw/d was based on maternotoxicity, increased resorptions and reduced foetal weight at the next higher dose.

Tolerable daily intake. An ADI was not established as bromadiolone residues are not expected to be present in the food supply. A TDI is maintained to serve as a guideline with which potential dietary exposure assessments can be undertaken in the event of unintentional presence.

Bromide

1

9 (H)

10 October 2016

12–week oral human study; no neurophysiological or endocrinological effects were observed at the highest tested dose of 9 mg/kg  w/d.

(JMPR-88).

Bromopropylate

0.03

2.8

31 May 1994

1–year dietary dog study; a NOAEL of 2.8 mg/kg bw/d was based on reduced body weight gain at the next higher dose.

 

Bromoxynil

0.003

0.3

19 February 1993

1–year dietary dog study; a NOAEL of 0.3 mg/kg bw/d was based on reduced body weight gain at the next higher dose.

 

Bromuconazole

0.02

2

17 June 1994

2–year dietary rat study; a NOAEL of 2 mg/kg bw/d was based on fatty vacuolation and nodular hyperplasia in the liver at the next higher dose.

 

Bupirimate

0.05

5

7 June 1978

   

Bupivacaine

0.001

1 [LOAEL]

10 June 2008

A LOAEL of 1 mg/kg bw was calculated from the lowest therapeutic dose.

 

Buprofezin

0.01

1

18 January 2000

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on increased kidney and heart weights and thickening and hyperplasia of thyroidal epithelial cells at the next higher dose. This NOAEL is supported by a 2–gen reproduction rat study; a NOAEL of 0.9 mg/kg bw/d was based on maternotoxicity and foetotoxicty at the next higher dose.

 

Butafenacil

0.004

0.36

12 April 2001

18–month dietary mouse study; a NOAEL of 0.36 mg/kg bw/d was based on haematological effects and liver toxicity at the next higher dose.

 

Butralin

0.2

15

14 August 1992

Developmental gavage rabbit study; a NOAEL of 15 mg/kg bw/d was based on maternal toxicity (reduced body weight gain) and foetal defects at the next higher dose.

 

Butroxydim

0.005

0.5

18 January 1993

1–year dietary dog study; a NOAEL of 0.5 mg/kg bw/d was based on organ weight changes and increased alkaline phosphatase levels at the next higher dose.

 

C

Cadusafos

0.00001

0.001

13 August 1992

1–year oral (gelatin capsule) dog study; a NOAEL of 0.001 mg/kg bw/d was based on inhibition of plasma cholinesterase activity at the next higher dose.

 

Captan

0.1

10

5 February 1997

Developmental rabbit study; a NOAEL of 10 mg/kg bw/d was based on reduced maternal body weight and increased skeletal variations in foetuses at the next higher dose.

 

Carbaryl

0.008

16 [LOAEL]

13 December 2002

2–year dietary mouse study; based on vascular tumour formation at the LOAEL of 16 mg/kg bw/d.

 

Carbendazim

0.03

2.5

9 May 1979

   

Carbofuran

0.003

0.33

10 September 1987

   

Carbosulfan

0.01

1

17 January 1997

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on clinical signs, iris atrophy and plasma ChE inhibition at the next higher dose.

 

Carboxin

0.08

8.5

18 February 1987

   

Carfentrazone ethyl

0.03

3

3 August 1998

2–year dietary rat study; a NOAEL of 3 mg/kg bw/d was based on red fluorescence seen in the liver at the next higher dose.

 

Carprofen

0.005

1

4 September 1997

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on intestinal ulceration and peritonitis at the next higher dose.

 

Cefapirin

0.02

20 [LOAEL]

5 September 1997

13–week dietary dog study; based on vomiting and increased weight gain at the LOAEL of 20 mg/kg bw/d.

Large uncertainty (safety) factor applied due to incomplete database; absence of chronic studies and the absence of a NOAEL.

Ceftiofur sodium

0.03

30

18 January 1993

3–month oral (gelatin capsule) dog study; a NOAEL of 30 mg/kg bw/d was based on clinical signs, reduction in blood platelet counts (thrombocytopenia) and low RBC (mild anaemia) at the next higher dose.

Large uncertainty (safety) factor applied due to incomplete database; absence of chronic toxicity studies.

Cefuroxime sodium

0.4

400

12 August 1996

27–week gavage dog study; a NOAEL of 400 mg/kg bw/d was based on anaemia, reduced plasma cholesterol, and increased triglycerides at the next higher dose.

 

Cephalexin

0.01

(M)

22 November 2000

 

The limited toxicology data were not sufficient to allow establishment of a toxicological ADI. A microbiological ADI of 0.01 mg/kg bw/d for cephalexin based on the use of the JECFA formula was established.

Cephalonium

0.02

39

11 July 1996

13–week dietary rat study; a NOAEL of 39 mg/kg bw/d was based on elevated kidney weights at the next higher dose.

Large uncertainty (safety) factor applied due to incomplete database; absence of chronic and reproduction toxicity studies.

Cetrimide

0.01

25 [LOAEL]

10 June 2008

21–day dietary rat study; based on reduced body weight gain and food consumption at the LOAEL of 25 mg/kg bw/d (EMEA, 1996).

 

Chlorantraniliprole

1.6

158

9 May 2008

2–year dietary mouse study; a NOAEL of 158 mg/kg bw/d was based on increased liver weights and increased eosinophilic foci of cellular alteration accompanied by hepatocellular hypertrophy at the next higher dose.

 

Chlordane

0.0005 (TDI)

JMPR'94

21 October 2003

 

Tolerable daily intake. Conventional ADI not maintained as chlordane is no longer used in agricultural practice. A TDI is maintained to enable potential dietary exposure assessments to be undertaken.

Chlorfenapyr

0.02

2.1

22 August 1995

1–year dietary dog study; a NOAEL of 2.1 mg/kg bw/d was based on elevated creatinine levels at the next higher dose.

 

Chlorfenvinphos

0.0005

0.05

29 October 1998

2–year dietary rat study; a NOAEL of 0.05 mg/kg bw/d was based on plasma ChE inhibition at the next higher dose. 2–gen reproduction rat study; a NOAEL of 0.05 mg/kg bw/d was based on plasma and brain ChE inhibition at the next higher dose.

 

Chlorfluazuron

0.005

0.56

12 November 1987

   

Chlorhexidine

0.2

25

14 February 1985

   

Chloridazon

0.04

4.1

2 December 1988

   

Chlormequat

0.07

7.5

30 August 1991

2–year dietary dog study; a NOAEL of 7.5 mg/kg bw/d was based on excessive salivation and muscle weakness at the next higher dose.

 

Chloropicrin

0.001

0.1

16 January 2014

1–year oral (gelatin capsule) dog study; a NOAEL of 0.1 mg/kg bw/d was based on vomiting (emesis) at the next higher dose. 2–year gavage rat study; a NOAEL of 0.1 mg/kg bw/d was based on hyperkeratosis in the nonglandular stomach and reduced body weight and body weight gain at the next higher dose.

 

Chlorothalonil

0.01

1.5

14 February 1991

   

Chlorpropham

0.05

5

16 July 1996

60–week dietary dog study; a NOAEL of 5 mg/kg bw/d was based on altered thyroid function at the next higher dose.

 

Chlorpyrifos

0.003

0.03 (H)

17 December 1998

28–day human study; a NOAEL of 0.03 mg/kg bw/d was based on inhibition of plasma cholinesterase activity at the next higher dose.

 

Chlorpyrifos-methyl

0.01

0.1

10 February 1988

   

Chlorsulfuron

0.05

5

5 August 1982

   

Chlortetracycline

0.003

0.03(H)

15 May 1995

7–day human oral study; a NOAEL of 0.03 mg/kg bw/d was based on the elimination of oxytetracycline susceptible strains of intestinal microflora at the next higher dose.

The NOAEL of oxytetracycline has been applied to chlortetracycline due to similarities in structure and microbiological potency.

Chlorthal-dimethyl

0.01

1

29 April 1994

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on dose-related decreases in thyroxin (T4) and increases in TSH levels, increases in thyroid/parathyroid weight, and gross and histopathological abnormalities in the lungs, liver, thyroid, eye and kidney at the next higher dose.

 

Cinmethylin

0.01

11 [LOAEL]

20 August 2003

Reproduction rat study; based on an increased incidence of parenchymal hepatocellular vacuolation in the liver at the lowest tested dose (LOAEL) of 11 mg/kg bw/d.

The LOAEL was considered appropriate, as the figure is lower than the lowest clear NOAEL of 3 mg/kg/d in a rabbit developmental study, with an uncertainty (safety) factor of 100.

Clavulanic acid

0.01

10

8 March 1995

6–month gavage dog study; based on liver toxicity at the next highest dose of 20 mg/kg bw/d.

Large uncertainty (safety) factor applied due to incomplete database; no chronic studies

Clethodim

0.01

1

20 June 1991

   

Clitoria ternatea

10

1000

23 November 2015

3–month dietary rat study; a NOAEL of 1000 mg/kg bw/d was based on an absence of any adverse effects at the highest tested dose.

 

Clodinafop-propargyl

0.004

0.37

28 April 1994

3–month dietary dog study; a NOAEL of 0.37 mg/kg bw/d was based on skin lesions and disturbances of the serum protein electrophoretic pattern at the next higher dose.

 

Clofentezine

0.02

2

11 September 1986

   

Clomazone

0.1

14

19 December 1997

1–year dietary dog study; a NOAEL of 14 mg/kg bw/d was based on increased absolute and relative liver weights at the next higher dose.

 

Cloprostenol

0.0005

0.05

11 November 1975

   

d-Cloprostenol

0.000075

0.00015

21 February 2017

3–gen reproduction rat study; a NOAEL of 0.00015 mg/kg bw/d (corresponding to 7.5 µg/kg bw/day d-cloprostenol) was based on a reduction in neonatal viability attributed to prematurity of the offspring at the next higher dose.

 

Clopyralid

0.5

50

12 November 1982

   

Cloquintocet-mexyl

0.04

4

28 April 1994

   

Cloquintocet acid

0.04

4.3

5 July 2016

2–year dietary rat study; a NOAEL of 4.3 mg/kg bw/d was based on thyroid follicular epithelium hyperplasia at the next higher dose.

 

Clorsulon

0.02

2

11 June 1993

Single-gen reproduction gavage rat study; a NOAEL of 2 mg/kg bw/d was based on increased gestation length at the next higher dose.

 

Closantel

0.025

2.5

12 November 1981

2–year dietary rat study; a NOAEL of 2.5 mg/kg bw/day was based on increased incidence of sperm granulomas in the epididymes of male rats at the next higher dose.

 

Clothianidin

0.05

9.7 [LOAEL]

1 August 2003

2–year dietary rat study; based on an increased incidence of interstitial hyperplasia in the ovaries at a LOAEL of 9.7 mg/kg bw/d.

 

Cloxacillin

0.2

500

28 June 2001

12–week dietary rat study; a NOAEL of 500 mg/kg bw/d was based on absence of any observed adverse effects at the highest tested dose.

Large uncertainty (safety) factor due to limited toxicological data.

Codling Moth Granulosis Virus

   

22 November 2011

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Coumaphos

0.0005

0.05

7 December 1971

1–year dietary dog study; a NOAEL of 0.05 mg/kg bw/d was based on inhibition of plasma cholinesterase activity at the next higher dose.

 

Coumatetralyl

0.000003 (TDI)

0.0068

15 September 2000

16–week dietary rat study; NOAEL of 0.0068 mg/kg bw/d was based on significantly increased blood clotting time and haemorrhage at the next higher dose.

Tolerable daily intake. An ADI was not established as coumatetralyl residues are not expected to be present in the food supply. A TDI is maintained to serve as a guideline with which potential dietary exposure assessments can be undertaken in the event of unintentional presence.

Cyanamide

0.002

0.2

14 August 1992

   

Cyanazine

0.002

0.2

11 September 1986

   

Cyantraniliprole

0.01

1

21 January 2013

1–year dietary dog study; a NOAEL of 1 mg/kg/bw/d was based on increased liver weight and a reduced cholesterol concentration at the next higher dose.

 

Cyazofamid

1.2

124

6 June 2013

18–month carcinogenicity mouse study; a NOAEL of 124 mg/kg/bw/d was based on increased indicence of hematocysts in the ovaries at the next higher dose.

 

Cyclanilide

0.01

2.5

17 April 1998

2–gen reproduction rat study; a NOAEL of 2.5 mg/kg bw/d was based on renal tubular mineralisation at the next higher dose.

 

Cyclaniliprole

0.04

4

29 February 2016

1–year dietary dog study; a NOAEL of 1.29 mg/kg bw/d was based on increased liver weights (absolute/relative) and increased ALP at the next higher dose.

 

Cycloxydim

0.06

6.4

17 May 1990

   

Cyflufenamid

0.04

4.14

29 May 2012

1–year dietary dog study; a NOAEL of 4.14 mg/kg bw/d was based on elevated alkaline phosphatase levels at the next higher dose.

 

Cyfluthrin

0.02

2.5

14 February 1985

   

Cyhalofop-butyl

0.002

0.2

28 January 2005

2–year dietary rat study; a NOAEL of 0.2 mg/kg bw/d was based on increased incidence of spots in the livers at the next higher dose.

 

Gamma-cyhalothrin

0.0005

0.5

12 August 2003

Developmental rat study; a maternal NOAEL of 0.5 mg/kg bw/d was based on reduced body weight gain and clinical signs among dams at the next higher dose.

 

Cypermethrin

0.05

5

10 February 1988

2–year dietary rat study; a NOAEL of 5 mg/kg bw/d was based on increased liver weights and some haematological and biochemical changes observed at the next higher dose.

 

Cyphenothrin

0.03

3

30 August 1991

13 and 52 week dietary dog studies; a NOAEL of 3 mg/kg/d was based on tremor, lethargy, emesis and reddening or paleness of the oral mucosa at the next higher dose.

 

Cyproconazole

0.01

1

22 February 1990

1–year dietary dog study; a NOAEL of 1 mg/kg bw/d was based on increased liver weights, liver-related clinical chemistry parameters and histopathological findings at the next higher dose.

 

Cyprodinil

0.03

2.7

19 August 1994

2–year dietary rat study; a NOAEL of 2.7 mg/kg bw/d was based on an increased incidence of cystic degeneration/spongiosis hepatis in the liver at higher doses.

 

Cyromazine

0.02

1.8

8 April 1998

2–year dietary rat study; a NOAEL of 1.8 mg/kg bw/d was based on reduced body weight gain at the next higher dose.

 

D

Daminozide

0.7

75

11 September 1986

   

Dazomet

0.0005

0.5

27 November 1996

   

DDT

0.002 (TDI)

0.25

21 October 2003

 

Tolerable daily intake. Conventional ADI not maintained as DDT is no longer used in agricultural practice. A TDI is maintained to enable potential dietary exposure assessments to be undertaken.

Decoquinate

0.075

15

4 June 2013

12–week dietary dog study; a NOAEL of 15 mg/kg bw/d was based on subdued behaviour at the next higher dose.

 

Deltamethrin

0.01

1

6 November 1980

2–year dietary dog study; a NOAEL of 1 mg/kg bw/d was based on an absence of any adverse effects at the highest tested dose.

 

Derquantel

0.0005

0.1 [LOAEL]

27 May 2011

3–month capsule fed dog study; based on clinical signs (protruding nictitating membranes, dilated pupils, eye redness and decreased indirect pupillary light response) at the LOAEL of 0.1 mg/kg bw/d.

 

Dexamethasone

0.000015

0.0015

10 October 2016

7–day gavage rat study; a NOAEL of 0.0015 mg/kg bw/d was based on the induction of tyrosine aminotransferase activity in the liver at the next higher dose.

Long history of safe use in human medicine (JECFA-08).

Diafenthiuron

0.003

0.3

5 January 1993

12–month dietary dog study; a NOAEL of 0.3 mg/kg bw/d was based on reduced body weight gain at the next higher dose. This NOAEL was supported by a 2–year dietary rat study; a NOAEL of 0.32 mg/kg bw/d was based on testicular enlargement at the next higher dose.

 

Diazinon

0.001

0.02 (H)

29 April 1999

37–43 day human study; a NOAEL of 0.02 mg/kg bw/d was based on plasma ChE inhibition at the next higher dose.

 

Dicamba

0.03

3

20 June 1991

Developmental rabbit study; a NOAEL of 3 mg/kg bw/d was based on reduced maternal body weight gain at the next higher dose.

 

Dichlobenil

0.01

1.25

14 August 1992

2–year dietary dog study; a NOAEL of 1.25 mg/kg bw/d was based on liver toxicity (increased liver weight, liver enzymes, cholesterol and triglycerides) and histopathological changes in the liver at the next higher dose.

See 2,6-dichlobenzamide (BAM) - major plant metabolite

Dichlofluanid

0.03

2.7

29 May 1986

2–year dietary dog study; a NOAEL of 2.7 mg/kg/d was based on hypertrophy in the liver at the next higher dose.

 

2,6-Dichlorobenzamide (BAM)

0.02

2

26 November 2015

2–year dietary rat study; a NOAEL of 2 mg/kg bw/d was based on reduced body weight, increased incidences of eosinophilic and basophilic foci in the livers and fat deposition and cellular degeneration in the liver at the next higher dose.

An important plant metabolite common to dichlobenil and fluopicolide

2,4-Dichlorophenoxyacetic acid (2,4-D)

0.01

1

23 June 2006

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on abnormal renal morphology at the next higher dose.

 

Dichlorprop

0.03

3

9 July 1998

13–week dog dietary study; a NOAEL of 3 mg/kg bw/d was based on changes in clinical chemistry and kidney discolouration at the next higher dose.

 

2,2-Dichloropropionic acid (2,2-DPA)

0.2

15

17 November 1989

   

Dichlorprop-P

0.03

6

2 November 2006

18–month dietary mouse study, a NOAEL of 6 mg/kg bw/d was based on increased incidence of chronic nephropathy observed at the next higher dose.

 

Dichlorvos

0.001

0.014 (H)

6 April 2004

28–day human study; a NOAEL of 0.014 mg/kg bw/d was based on inhibition of plasma cholinesterase activity at the next higher dose.

 

Diclofop-methyl

0.002

0.25

6 February 1986

2–year dietary mouse study; a NOAEL of 0.25 mg/kg bw/d was based on increased organs weights and serum alkaline phosphatase levels at the next higher dose.

 

Dicofol

0.001

0.12

5 December 1990

   

Dicyclanil

0.007

0.7

14 October 2005

12–month dietary dog study; a NOAEL of 0.71 mg/kg  bw/d was based on increased plasma cholesterol levels at the next higher dose.

 

Dieldrin

0.0001 (TDI)

JMPR'94

21 October 2003

 

Tolerable daily intake. Conventional ADI not maintained as dieldrin is no longer used in agricultural practice. A TDI is maintained to enable potential dietary exposure assessments to be undertaken.

Difenoconazole

0.01

1

5 December 1990

   

Difethialone

0.0000006 (TDI)

0.00125

19 July 1993

Developmental rabbit study; a NOAEL of 0.00125 mg/kg/d based on the incidence of incompletely ossified sternebra at the next higher dose.

Tolerable daily intake. An ADI was not established as difethialone residues are not expected to be present in the food supply. A TDI is maintained to serve as a guideline with which potential dietary exposure assessments to be undertaken in the event of unintentional presence.

Diflubenzuron

0.02

2

14 February 1985

2–year rat and 1–year dog dietary studies; a NOAEL of 2 mg/kg/d based on increased pigmentation in macrophages and Kupffer cells of the liver at the next higher dose.

 

Diflufenican

0.2

16.3

11 August 1988

2–year dietary rat study; a NOAEL of 16.3 mg/kg bw/d based on a reduction in body weight gain at the next higher dose.

 

Dimethenamid-P

0.03

5 [LOAEL]

12 August 2003

2–year dietary rat study; based on an increased incidence of parathyroid hyperplasia at the lowest tested dose (LOAEL) of 5.1 mg/kg bw/d.

 

Dimethoate

0.001

0.1

31 May 2012

Developmental neurotoxicity rat study; a NOAEL of 0.1 mg/kg bw/d was based on increased pup mortality at the next higher dose.

 

Dimethomorph

0.06

6

12 July 1996

2–gen reproduction rat study; a NOAEL of 6 mg/kg bw/d was based on reduced female weight gain at the next higher dose.

 

Dinoprost

0.0005

1

17 March 1976

   

Dinotefuran

0.2

22

10 August 2015

1–year dietary dog study; a NOAEL of 22 mg/kg bw/d was based on reduced body weight gain at the next higher dose.

 

Diphenylamine

0.02

1.5

2 June 1988

   

Diquat

0.002

0.2

28 May 2002

2–year dietary rat study; a NOAEL of 0.2 mg/kg bw/d was based on lenticular cataract formation at the next higher dose.

 

Disodium methylarsonate (DSMA)

0.0005

0.5

10 November 1994

   

Dithianon

0.007

0.66

2 February 1993

2–year dietary rat study; a NOAEL of 0.66 mg/kg bw/d was based on reduced body weight, food intake and increased liver and kidney weights at the next higher dose.

 

Dithiopyr

0.005

0.5

13 August 1992

   

Diuron

0.007

0.7

4 February 2005

In a follow-up 6–month study to a 2–year rat dietary study; a NOAEL of 0.7 mg/kg bw/d was based on reduced Hb and increased reticulocyte counts at the next higher dose. This NOAEL was supported by a 2–year dietary dog study; a NOAEL 0.6 mg/kg bw/d was based on abnormal haemoglobin spectral pigments at higher doses.

 

Dodine

0.1

10

26 November 2002

1–year dietary dog study; a NOAEL of 10 mg/kg bw/d was based on diarrhoea, reduced food intake and body weight loss at the next higher dose.

 

Doramectin

0.001

0.1

14 October 2002

3–month gavage dog study; a NOAEL of 0.1 mg/kg bw/d was based on pupil dilation (mydriasis) exhibited at the next higher dose.

 

E

Emamectin

0.002

0.25

26 February 1999

1–year gavage dog study; a NOAEL of 0.25 mg/kg bw/d was based on neurotoxicity (tremors, stiffness in hind legs) and peripheral nerve degeneration and muscle degeneration at the next higher dose. 2–year dietary rat study; a NOAEL of 0.25 mg/kg bw/d was based on elevated serum triglyceride and bilirubin levels at the next higher dose.

 

Endothal

0.03

3.75

5 December 1990

   

Endrin

0.0002 (TDI)

JMPR'94

21 October 2003

 

Tolerable daily intake. A conventional ADI not maintained as endrin is no longer used in agricultural practice. A TDI is maintained to enable potential dietary exposure assessments to be undertaken.

Enterococcus faecium

 

 

4 September 2002

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Epoxiconazole

0.01

1

16 April 2002

1–year dietary dog study; based on the absence of any treatment related effects at the highest tested dose of 1.1 mg/kg bw/d. 78–week dietary mouse study; a NOAEL of 0.81 mg/kg bw/d was based on reduced bodyweight gain and increased liver weight at the higher dose (36 mg/kg bw/d).

 

Eprinomectin

0.005

1

13 October 1997

2–gen reproduction dietary rat study; a NOAEL of 1 mg/kg bw/d was based on tremors in pups at the next higher dose. 1–year gavage dog study; a NOAEL of 1 mg/kg bw/d was based on pupil dilation (mydriasis) and focal neuronal degeneration in the brain at the next higher dose.

 

Esbiothrin

0.03

3

15 September 1993

1–year dietary dog study; a NOAEL of 3 mg/kg bw/d was based on increased thyroid weight at the next higher dose.

 

Esfenvalerate

0.008

7.5

17 March 1993

13–week dietary rat study; a NOAEL of 7.5 mg/kg bw/d was based on parenchymal cell hypertrophy in parotid salivary gland at the next higher dose.

 

Ethametsulfuron-methyl

0.2

21

17 January 2001

2–year dietary rat study; a NOAEL of 21 mg/kg bw/d was based on enlarged mammary glands in females and reduced serum sodium levels at the next higher dose.

 

Ethephon

0.02

0.17(H)

18 February 1987

3–week human study; a NOAEL of 0.17 mg/kg bw/d was based on inhibition of plasma cholinesterase levels at the next higher dose. 

 

Ethion

0.001

0.1

10 June 1987

2–year dietary rat study and 3–gen reproduction rat study; a NOAEL of 0.1 mg/kg bw/d was based on inhibition of plasma cholinesterase activity at the next higher dose.

 

Ethofumesate

0.3

30

11 November 1976

   

Ethoxysulfuron

0.06

6.2

12 May 2004

3–month dietary dog study; a NOAEL of 6.2 mg/kg bw/d was based on increased thyroid weight in association with follicular hyperplasia at the next higher dose.

 

Ethyl dipropylthiocarbamate (EPTC)

0.09

9

12 January 1995

2–year dietary rat study; a NOAEL of 9 mg/kg bw/d was based on clinical and pathological effects indicative of neuromuscular toxicity at the next higher dose.

 

Ethyl formate

   

26 November 2003

 

No residues expected in commodities above the natural formate level of 0.6 mg/kg. Any residues above this level could be considered against a group ADI for formic acid (3 mg/kg bw/d).

Etoxazole

0.04

4

17 December 2003

2–year dietary rat study; a NOAEL of 4 mg/kg bw/d was based on increased liver weights at the next higher dose. 1–year dietary dog study; a NOAEL of 4.6 mg/kg bw/d was based on increased liver weights and an increased incidence of hepatocellular swelling at the next higher dose.

 

Etridiazole

0.03

3

30 August 1991

2–year dietary dog study; a NOAEL of 3 mg/kg bw/d was based on reduced body weight gain and Increased serum alkaline phosphatase, cholesterol and blood clotting time at the next higher dose.

 

F

Febantel

0.02

2

15 July 1996

2–gen reproduction rat study; a NOAEL of 2 mg/kg bw/d was based on hepatocellular hypertrophy in the liver at the next higher dose.

 

Fenamiphos

0.0001

0.014

7 November 2005

2–year dietary dog study; a NOAEL of 0.014 mg/kg bw/d was based on inhibition of plasma cholinesterase activity at the next higher dose.

 

Fenbendazole

0.05

5

14 February 1991

   

Fenbuconazole

0.006

0.6

2003

1–year dietary dog study; a NOAEL of 0.6 mg/kg bw/d was based on reduced body weight gains and increased incidences of hepatocyte pigment at the next higher dose. 2–gen reproduction rat study; a NOAEL of 0.6 mg/kg bw/d was based on increase in stillborn pups and decrease in delivered pups, live pups/litter, viability during lactation and pup body weights at the next higher dose.

 

Fenbutatin-oxide

0.01

1

10 September 1987

   

Fenhexamid

0.2

17.4

16 December 1998

1–year dietary dog study; a NOAEL of 17.4 mg/kg bw/d was based on increased adrenal weight, intracytoplasmic vacuoles in the adrenal cortex, and anaemia (incl. Heinz bodies) at the next higher dose.

 

Fenitrothion

0.002

0.2

6 November 1997

1–year dietary dog study; a NOAEL of 0.2 mg/kg bw/d was based on a reduction in plasma cholinesterase activity at the next higher dose.

 

Fenoxaprop-P-ethyl

0.004

0.4

14 February 1991

2–year dietary dog study; a NOAEL of 0.4 mg/kg bw/d was based on reduced bodyweight gain at the next higher dose.

 

Fenoxycarb

0.05

5

29 October 1998

18–month dietary mouse study; a NOAEL of 5 mg/kg bw/d was based on increased liver weight, increased incidence of pulmonary tumours and lower body weight at the next higher dose.

 

Fenpyrazamine

0.1

12.7

11 May 2015

2–year dietary rat study; a NOAEL of 12.7 mg/kg bw/d was based on increased liver weight and hepatocellular hypertrophy at the next higher dose.

 

Fenpyroximate

0.005

0.5

24 May 1993

   

Fenvalerate

0.02

1.7

10 June 1987

   

Fipronil

0.0002

0.02

27 June 1994

2–year dietary rat study; a NOAEL of 0.02 mg/kg bw/d was based on clinical signs of neurotoxicity, increased thyroid weight, decreased thyroxine (T4) levels and increased severity of progressive senile nephropathy at the next higher dose.

This is a group ADI which includes fipronil, desulfinyl fipronil, fipronil suphide and fipronil sulphone.

Flamprop-M-methyl

0.001

0.125

29 August 1991

2–year dietary rat study; a NOAEL of 0.125 mg/kg bw/d was based on increased liver weight and hypertrophy of the endoplasmic reticulum at the next higher dose.

 

Flavophospholipol

       

see: Bambermycin

Flazasulfuron

0.013

1.3

26 September 2011

2–year dietary rat study; a NOAEL of 1.3 mg/kg bw/d was based on chronic nephropathy observed at the next higher dose.

 

Flocoumafen

0.000001

0.0014

20 September 1995

3–month dietary rat study; a NOAEL of 0.0014 mg/kg bw/d was based on increased levels of serum cholesterol at the next higher dose.

 

Flonicamid

0.025

2.5

7 June 2012

Developmental rabbit study; a NOAEL of 2.5 mg/kg bw/d was based on abnormal lung lobation and absent kidney and ureter in foetuses at the next higher dose.

 

Florasulam

0.05

5

20 December 2007

1–year dietary dog study; a NOAEL of 5 mg/kg bw/d was based on hypertrophy of collecting duct epithelial cells of the kidney at the next higher dose.

 

Florfenicol

0.001

1

3 August 2001

1–year dietary dog study; a NOAEL of 1 mg/kg bw/d was based on increased liver weight and cystic epithelial hyperplasia of the gall bladder at the next higher dose.

 

Fluazifop-butyl

0.003

0.3

5 August 1982

   

Fluazinam

0.004

0.4

18 June 1993

   

Fluazuron

0.04

4.27

14 September 1993

2–year dietary mouse study; a NOAEL of 4.27 mg/kg bw/d was based on lenticular cataracts at the next higher dose.

 

Flubendiamide

0.01

1

14 December 2007

1–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on hepatoxicity and microcytic anaemia at the nex higher dose.

 

Fludioxonil

0.03

3.1

23 April 1997

2–year dietary rat study study; a NOAEL of 3.7 mg/kg bw/d was based on clinical signs, discoloured urine and reduced body weight gain at the next higher dose. 1–year dietary dog study; a NOAEL of 3.1 mg/kg bw/d was based on blue faeces, discoloured gastrointestinal tract and reduced body weight gain at the next higher dose.

 

Flufenoxuron

0.02

2.5

21 January 1997

1–year dietary dog study; a NOAEL of 2.5 mg/kg bw/d was based on mild anaemia (reduction in RBC and MCHC) and liver histopathology at the next higher dose.

 

Flugestone acetate

0.0001

0.2

19 February 1981

   

Flumethrin

0.003

0.31

18 October 2001

2–gen reproduction rat study; a NOAEL of 0.31 mg/kg bw/d was based on clinical signs, reduced food consumption and reduced body weight gain (parental effects) and reduced birth weight, pup survival and weight gain (reproductive effects) at the next higher dose.

 

Flumetsulam

1

100

14 February 1992

   

Flumiclorac pentyl

0.3

32

8 December 2004

18–month dietary mouse study, a NOAEL of 32 mg/kg bw/d was based on reduced RBC, Hb, Hct and hepatocellular hypertrophy in the liver at the next higher dose.

 

Flumioxazin

0.003

3

12 December 2002

Developmental rat study; a NOAEL of 3 mg/kg bw/d was based on increased incidence of cardiovascular abnormalities at the next higher dose.

 

Flunixin meglumine

0.006

0.6

29 September 2000

2–year mouse study; a NOAEL of 0.6 mg/kg bw/d was based on extramedullary haematopoiesis in the liver and kidney at the next higher dose.

 

Fluometuron

0.02

2

16 February 1989

   

Fluopicolide

0.08

7.9

26 November 2015

18–month dietary mouse study; a NOAEL of 7.9 mg/kg bw/d was based on increased liver weights, masses and nodules in the liver, and hepatocellular hypertrophy at the next higher dose. Supported by 2–year dietary rat study; a NOAEL of 8.4 mg/kg bw/d was based on increased centrilobular hypertrophy of the liver and increased kidney weights and lesions (cortical tubule cell basophilia, hyaline droplets and granular and hyaline casts) at the next higher dose. 

See 2,6-dichlobenzamide (BAM) -major plant metabolite

Fluopyram

0.01

1.2

2015

2–year dietary combined carcinogenicity/chronic toxicity study in rats using a NOAEL of 1.2 mg/kg/bw/d for effects seen on the liver, kidney, thyroid and eyes at the next highest dose and applying a 100 fold safety factor to account for both intra- and inter-species variation.

 

Flupropanate

0.002

5

10 September 1987

   

Flupyradifurone

0.08

7.8

11 August 2015

1–year dietary dog study; a NOAEL of 7.8 mg/kg bw/d was based on reduced bodyweights and skeletal muscle myofiber degeneration at the next higher dose. Supported by the 2–gen reproduction rat study; a NOAEL of 7.7 mg/kg bw/d was based on body weight loss at the next higher dose.

 

Fluquinconazole

0.005

0.5

2 July 1997

2–year dietary rat study; a NOAEL of 0.5 mg/kg bw/d was based on deaths, increased food and water consumption, reduced body weight gain and increased relative organ weights at the next higher dose. 1–year dietary dog study; a NOAEL of 0.5 mg/kg bw/d was based on clinical signs at the next higher dose.

 

Fluroxypyr

0.2

20

6 February 1986

2–year dietary mouse study; a NOAEL of 20 mg/kg bw/d was based on lenticular cataracts at the next higher dose.

 

Flutolanil

0.02

2

16 October 2001

2–year dietary rat study; a NOAEL of 2 mg/kg bw/d was based on an increased albumin:globulin ratio in males, and reduced bilirubin and dilation of the sinusoid in the liver in females at the next higher dose.

 

Flutriafol

0.01

1

20 June 1991

   

tau-Fluvalinate

0.005

0.5

5 November 1986

   

Fluxapyroxad

0.02

2.1

30 January 2012

2–year dietary rat study; a NOAEL of 2.1 mg/kg bw/d was based on increased liver weight at the next higher dose.

 

Forchlorfenuron

0.07

7

15 April 2005

2–year dietary rat study; a NOAEL of 7 mg/kg bw/d was based on tubular dilatation and inflammation in the kidneys at the next higher dose.

 

Fosetyl aluminium

1

103

18 February 1987

   

G

Gentamicin

0.05

5

6 May 1983

   

Gibberellic acid

5

550

13 January 1993

3–month dietary rat study; a NOAEL of 550 mg/kg bw/d was based on increased liver weight at the next higher dose.

 

Glufosinate

0.007

0.67

11 August 1988

   

Glufosinate ammonium

0.02

2.1

28 August 2001

130–week dietary rat study; a NOAEL of 2.1 mg/kg bw/d was based on inhibition of glutamine synthetase activity in the liver and brain, and decreased glutathione levels in the liver and blood at the next higher dose.

 

Glyphosate

0.3

30

14 February 1985

3–gen reproduction rat study; a NOAEL of 30 mg/kg bw/d was based on an absence of any adverse effects at the highest tested dose.

 

Guazatine

0.006

0.625

25 March 1997

1–year dietary dog study; a NOAEL of 0.625 mg/kg bw/d was based on reduced body weight gain and food consumption at the next higher dose.

 

H

Halauxifen-methyl

0.1

10

17 September 2014

3–month dietary rat study; a NOAEL of 10 mg/kg bw/d was based on induction of hepatic Cyp1a1 activity (aryl hydrocarbon receptor (AhR) pathway), increased liver weights and cholesterol and increased hepatocellular vacuolation at the next higher dose.

 

Halofuginone

0.0003

0.025

16 June 2006

Development rabbit study; a NOAEL of 0.025 mg/kg bw/d was based on reduced body weight gain and food consumption, mortality and abortions at the next higher dose.

 

Halosulfuron-methyl

0.01

1

19 November 1993

   

Haloxyfop

0.0003

0.03

12 November 1987

   

Heptachlor

0.0005 (TDI)

JMPR'94

21 October 2003

 

Tolerable daily intake. A conventional ADI not maintained as heptachlor is no longer used in agricultural practice. A TDI is maintained to enable potential dietary exposure assessments to be undertaken.

Hexaconazole

0.005

0.5

17 May 1990

   

Hexaflumuron

0.02

2

31 August 2001

1–year dietary dog study; a NOAEL of 2 mg/kg bw/d was based on Heinz bodies (intracellular inclusions of denatured haemoglobin) in RBC and methaemoglobin (heme group in RBC contains iron in the ferric (Fe3+) state and not the usual ferrous (Fe2+) state) formation at the next higher dose.

 

Hexazinone

0.1

10

12 November 1987

2–year dietary rat study; a NOAEL of 10 mg/kg bw/d was based on reduced body weight gain at the next higher dose.

 

Hexythiazox

0.03

3

29 May 1986

1–year dietary dog study; a NOAEL of 3 mg/kg bw/d was based on increased liver weight and adrenocortical hypertrophy at the next higher dose.

 

I

Imazalil

0.03

2.5

24 July 1997

1–year dietary dog study; a NOAEL of 2.5 mg/kg bw/d was based on reduced body weights, and increased relative liver weights, serum AP and GGT levels at the next higher dose.

 

Imazamox

2.8

282

11 March 1999

1–year dietary dog study; a NOAEL of 282 mg/kg bw/d was based on increased plasma creatine phosphokinase activity at the next higher dose.

 

Imazapic

0.3

137

17 May 1996

1–year dietary dog study; a NOAEL of 137 mg/kg bw/d was based on mild anaemia (reduced Hct, Hb and RBC levels) at the next higher dose.

 

Imazapyr

2.5

250

2 June 1998

1–year dietary dog study; a NOAEL of 250 mg/kg bw/d was based on the absence of signs of toxicity at the highest tested dose.

 

Imazethapyr

2.8

276

22 February 1990

2–year dietary rat study; a NOAEL of 276 mg/kg bw/d was based on reduced body weight gain at the next higher dose.

 

Imidacloprid

0.06

6

8 February 1993

2–year dietary rat study; a NOAEL of 6 mg/kg bw/d was based on increased mineralisation in the colloid of thyroid follicles at the next higher dose.

 

Imidocarb

0.05

5

16 August 1979

   

Imiprothrin

0.05

5

30 September 1996

1–year dietary dog study; a NOAEL of 5 mg/kg bw/d was based on increased salivation, diarrhoea, and incidence and severity of centrilobular hepatocytes, Kupffer cell pigmentation, and perivascular inflammatory cell infiltration in the liver at the next higher dose.

 

Indoxacarb

0.01

1

21 August 2006

1–year dietary dog study; a NOAEL of 1.1 mg/kg bw/d was based on RBC damage and a secondary increase in haematopoiesis in the spleen and liver at the next higher dose. Supported by 2–gen reproduction rat study; a NOAEL of 1.3 mg/kg bw/d was based on reduced body weight and food consumption in dams at the next higher dose.

 

Iodosulfuron-methyl-sodium

0.03

3

29 September 2000

2–year dietary rat study; a NOAEL of 3 mg/kg bw/d was based on reduced body weight gain at the next higher dose.

 

Ioxynil

0.004

0.04

18 February 1987

   

Ipconazole

0.015

1.5

18 January 2010

1–year oral (gelatin capsule) dog study; a NOAEL of 1.5 mg/kg bw/d was based on increased incidence and severity of bile duct proliferation and increased incidence in centrilobular hepatocyte hypertrophy at the next higher dose.

 

Iprodione

0.04

4

16 June 1986

1–year dietary dog study; a NOAEL of 4 mg/kg bw/d was based on increased adrenal and liver weight, increased AP and ALT and pathological changes in the adrenals and liver at the next higher dose.

 

Isoeugenol

0.2

500

20 August 1996

16–week dietary rat study; a NOAEL of 500 mg/kg bw/d was based on the absence of signs of toxicity at the highest tested dose.

Large uncertainty (safety) factor due to limited toxicological data; no reproduction or developmental studies.

Isofetamid

0.05

5

9 March 2017

An overall NOAEL of 5 mg/kg bw/d in the dietary 90–day and 1–year dog toxicity studies was based on decreased albumin, increased ALP, GGPT and liver weight with hepatocellular hypertrophy at the next higher dose.

 

Isopyrazam

0.06

5.5

24 May 2016

2–year dietary rat study; NOAEL of 5.5 mg/kg bw/d was based on reduced body weight gain, foci of eosinophilic hepatocytes and clinical chemistry changes (triglycerides, bilirubin) at the next higher dose.

 

Isoxaben

0.05

5

9 August 1995

2–year dietary rat study; a NOAEL of 5 mg/kg bw/d was based on renal pathology at the next higher dose.

 

Isoxaflutole

0.02

2

6 May 1997

2–year rat dietary study; a NOAEL of 2 mg/kg bw/d was based on many histopathological changes in the liver, nerves, skeletal muscle, and cornea of the eye at the next higher dose. Supported by a 2–gen reproduction rat study; a NOAEL of 2 mg/kg bw/d for maternal and pup toxicity was based on increased liver weight, liver hypertrophy, vacuolation, reduced pup weight and viability.

 

Ivermectin

0.001

0.1

16 October 1998

Developmental mouse study; a NOAEL of 0.1 mg/kg bw/d was based on maternotoxicity at the next higher dose.

 

k

Ketoprofen

0.001

0.1

8 December 2000

Acute pharmacological rabbit study; a NOAEL of 0.1 mg/kg bw/d was based on inhibition of platelet aggregation at the next higher dose.

 

Kitasamycin

0.5

1000

22 March 1979

   

Kresoxim-methyl

0.4

36

25 June 1999

2–year dietary rat study; a NOAEL of 36 mg/kg bw/d was based on reduced body weight, increased liver weight, elevated enzyme activity and liver changes at the next higher dose.

 

L

Lactobacillus acidophilus

   

4 September 2002

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Lactobacillus brevis

   

4 September 2002

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Lactobacillus casei

   

4 September 2002

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Lactobacillus plantarum

   

4 September 2002

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Lambda-cyhalothrin

0.001

0.1

5 December 1990

1–year capsule fed dog study; a NOAEL of 0.1 mg/kg bw/d was based on neurotoxic effects (convulsions, ataxia) at the next higher dose.

 

Lasalocid

0.001

2

9 February 1977

   

Levamisole

0.003

6

14 November 1974

3–month dietary dog study; a NOAEL of 6 mg/kg bw/d was based on the absence of any adverse effects observed at the highest tested dose.

 

Lignocaine

0.009

8.6 [LOAEL]

10 June 2008

An effective human therapeutic dose is 3 mg/kg bw. Assuming a 35% bioavailability via the oral route, a corresponding oral dose can be estimated to be 3/0.35 = 8.6 mg/kg bw.

 

Lincomycin

1

100

5 August 1983

   

Linuron

0.01

1.25

11 September 1986

   

Lufenuron

0.02

2.1

4 March 1994

2–year dietary rat study; a NOAEL of 2.1 mg/kg bw/d was based on seizures, lung and gastrointestinal lesions at the next higher dose. 18–month dietary mouse study; a NOAEL of 2.1 mg/kg bw/d based on deaths and clinical signs at the next higher dose.

 

M

Maduramicin

0.001

0.1

5 November 1986

   

Maldison

0.02

2

12 April 2005

2–year dietary rat study; a NOAEL of 2 mg/kg bw/d was based on inhibition of RBC cholinesterase activity at the next higher dose.

 

Maleic hydrazide

5

571

5 January 1993

   

Mancozeb

0.006

0.6

27 November 1992

2–year dietary dog study; a NOAEL of 0.6 mg/kg bw/d was based on reduced iodine uptake at the next higher dose.

 

Mandestrobin

0.2

19.2

30 March 2016

1–year dietary dog study; a NOAEL of 19.2 mg/kg bw/d was based on dark liver, centrilobular hepatocyte hypertrophy and pigmented hepatocytes at the next higher dose.

 

Mandipropamid

0.05

5

9 April 2010

1–year dietary dog study; a NOAEL of 5 mg/kg bw/d was based on changes in clinical chemistry, increased liver weight and pigment in hepatocytes at the next higher dose.

 

MCPA

0.01

1.1

28 April 1994

2–year dietary rat study; a NOAEL of 1.1 mg/kg bw/d was based on increased serum levels of alanine aminotransferase (ALT) at the next higher dose.

ADI is for the sum of MCPA, its salts and esters, expressed as MCPA acid equivalents.

MCPB

0.01

1.1

12 May 1994

   

Mebendazole

0.08

8

14 February 1975

   

Mecoprop

0.01

1

3 July 1998

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on increased kidney weight at the next higher dose.

 

Mecoprop-P

0.04

4

17 January 2001

18–month dietary mouse study; a NOAEL of 4 mg/kg bw/d was based on increased kidney weight and chronic nephropathy at the next higher dose.

 

Mefenpyr-diethyl

0.03

2.8

13 May 1997

87–week dietary mouse study; a NOAEL of 2.8 mg/kg bw/d was based on hepatocellular hypertrophy in the liver at the next higher dose.

 

Meloxicam

0.0001

0.125 [LOAEL]

5 February 1999

A segment III (perinatal and post-natal toxicity) reproduction study in rats; clinical signs, prolonged gestation and delivery duration, stillbirths and reduced pup viability at the lowest tested dose of 0.125 mg/kg bw/d. 

 

Mepiquat

0.15

15

30 August 1991

   

Mesosulfuron-methyl

1

100

27 May 2002

18–month dietary mouse study; a NOAEL of 100 mg/kg bw/d was based on oligospermia in the epididymides at the next higher dose.

 

Metalaxyl

0.03

3

7 May 1981

2–year dietary rat study; a NOAEL of 3 mg/kg bw/d based on increased liver weight at the next higher dose.

 

Metaldehyde

0.005

5

11 September 1986

   

Metarhizium Anisopliae var. Acridum (isolate FI-985)

   

4 September 2003

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Metazachlor

0.2

17.6

15 July 2016

2–year dietary rat study; a NOAEL of 17.6 mg/kg bw/d was based on reduced food consumption and bodyweight gain, increased liver weight with enlarged hepatocytes and hepatocyte vacuolation, and decreased haemoglobin concentration at the next higher dose.

 

Methabenzthiazuron

0.004

7.5

22 July 1969

   

Methamidophos

0.0003

0.03

30 January 2004

8–week dietary rat study; a NOAEL of 0.03 mg/kg bw/d was based on inhibition of plasma, RBC and brain cholinesterase activity at the next higher dose.

 

Methidathion

0.002

0.16

31 May 2004

3–month dietary dog study; a NOAEL 0.16 mg/kg bw/d was based on evidence of liver cholestasis and inhibition of RBC cholinesterase activity at the next higher dose.

 

Methiocarb

0.002

0.2

1 March 2000

2–year dietary dog study; a NOAEL 0.2 mg/kg bw/d was based on inhibition of plasma cholinesterase activity and reduced food consumption at the next higher dose.

 

Methomyl

0.01

1.25

14 February 1991

   

Methoprene

0.4

35

14 January 2000

18–month dietary mouse study; a NOAEL of 35 mg/kg bw/d was based on pigment deposition in the liver at the next higher dose.

 

Methoxychlor

0.1 (TDI)

JMPR'94

21 October 2003

 

Tolerable daily intake. A conventional ADI not maintained as methoxychlor is no longer used in agricultural practice. A TDI is maintained to enable potential dietary exposure assessments to be undertaken.

Methoxyfenozide

0.1

10

12 January 2001

89–99 week dietary rat study; a NOAEL of 10 mg/kg bw/d was based on reduced RBC and increased liver weight at the next higher dose. 1–year dietary dog study; a NOAEL of 10 mg/kg bw/d was based on an increase in methaemoglobin (heme group in RBC contains iron in the ferric (Fe3+) state and not the usual ferrous (Fe2+) state) and platelet count and reduced RBC at the next higher dose.

 

Methyl benzoquat

0.05

100

10 November 1977

 

 

Methyl bromide

0.0004

0.4

14 September 2001

3–month gavage rat study; a NOAEL of 0.4 mg/kg bw/d was based on clinical signs at the next higher dose.

 

1-Methylcyclopropene

   

10 October 2003

There was insufficient information to establish an ADI, however, based on its proposed pattern of use the dietary intake is likely to be low.

 

Metiram

0.02

5

10 February 1988

13–week dietary rat study; a NOAEL of 5 mg/kg bw/d was based on atrophy of skeletal muscle fibres, decreased thyroxine (T4) levels and altered thyroid function at the next higher dose.

 

Metolachlor

0.08

7.5

12 November 1987

   

Metosulam

0.05

5

18 January 1993

   

Metrafenone

0.25

25

13 April 2010

2–year dietary rat study; a NOAEL of 25 mg/kg bw/d was based on reduced body weight gain, increased liver weight with centrilobular hepatocellular hypertrophy and eosinophilic hepatocellular alterations at the next higher dose.

 

Metribuzin

0.02

2

4 November 1982

   

Metsulfuron-methyl

0.01

1

1 August 1985

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on reduction in bodyweight at the next higher dose.

 

Mevinphos

0.002

0.015 (H)

29 October 1998

30–day oral human study; a NOAEL of 0.015 mg/kg bw/d was based on the inhibition of RBC cholinesterase activity at the next higher dose.

 

Milbemectin

0.007

0.7

29 August 2005

2–year dietary rat study; a NOAEL of 0.7 mg/kg bw/d was based on increased kidney weight and endometrial polyps at the next higher dose.

 

Molinate

0.002

0.2

5 November 1986

3–gen reproduction rat study; a NOAEL of 0.2 mg/kg bw/d was based on testicular degeneration at the next higher dose.

 

Monensin

0.01

1.25

10 NOvember 1977

   

Monepantel

0.03

2.96

10 November 2009

1–year dietary dog study; a NOAEL of 2.96 mg/kg bw/d was based on increased thyroid weight, increased liver pigmentation, reduced serum A/G ratio and increased alkaline phosphatase activity at the next higher dose.

 

Monosodium Methylarsonate (MSMA)

0.0005

0.5

10 November 1994

   

Morantel

0.01

1.2

26 November 2002

2–year dietary rat study; a NOAEL of 1.2 mg/kg bw/d was based on reduced body weight gain, food consumption and food conversion efficiency at the next higher dose. 2–year oral toxicity dog study; a NOAEL of 1.2 mg/kg bw/d was based on increased adrenal and liver weights at the next higher dose.

 

Moxidectin

0.01

1

7 June 2004

3–month dietary dog study; a NOAEL of 0.3 mg/kg bw/d was based on reduced weight gain at the next higher dose. 1–year dietary dog study; a NOAEL of 1.12 mg/kg bw/d was based on absence of any adverse effects at the highest tested dose. Developmental rabbit study; a NOAEL of 1 mg/kg bw/d was based on reduced bodyweight gain at the next higher dose.

 

Myclobutanil

0.03

2.6

12 November 1987

2–year dietary rat study; a NOAEL of 2.6 mg/kg bw/d was based on reduced testicular weight at the next higher dose.

 

N

Naphthalophos

0.0001

0.25

7 December 1971

   

Napropamide

0.1

11

29 July 1994

   

Narasin

0.01

1.5

5 August 1983

   

Neomycin

0.06

6 (JECFA'96)

28 February 1996

3–month dietary guinea pigs study; a NOAEL of 6 mg/kg bw/d was based on ototoxicity (inner ear damage) observed at the next higher dose.

 

Nicarbazin

2

240

4 November 1982

   

Niclosamide

0.1

14 (H)

20 September 2016

Short term repeat dose human therapeutic study; a LOAEL of 14 mg/kg bw/d was based on the lowest effective therapeutic (anthelmintic) dose in humans.

 

Nitroxynil

0.02

2

20 August 1974

 

 

Norflurazon

0.02

1.5

1 November 1984

   

Norgestomet

0.0000005

0.001

5 December 1985

   

Novaluron

0.01

1.1

17 January 2001

2–year dietary rat study; a NOAEL of 1.1 mg/kg bw/d was based on anaemia (reductions in RBC, MCHC and increased reticulocyte count), increased spleen weight and an increased incidence and severity of haemosiderosis in the spleen at the next higher dose.

 

Nuclear polyhedrosis virus of helicoverpa armigera occlusion bodies

   

17 December 2003

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

O

n-Octyl bicycloheptene dicarboximide

0.07

7.5

25 May 1995

1–year dietary dog study; a NOEL of 7.5 mg/kg bw/d was based on elevated serum enzyme activity, liver pigmentation and hepatocellular hypertrophy at the next higher dose.

 

Olaquindox

0.06

6

7 May 1981

   

Omethoate

0.0004

0.04

20 October 2005

2–year dietary rat study; a NOAEL of 0.04 mg/kg bw/d was based on inhibition of plasma cholinesterase activity at the next higher dose.

 

ortho-Phenylphenol

0.4

JMPR'99

21 October 2003

   

Oryzalin

0.1

12

5 May 1982

   

Oxabetrinil

0.005

10

2 May 1985

3–month dietary dog study; a NOAEL of 10 mg/kg bw/d was based on reduced body and thymus weights at the next higher dose.

 

Oxadiargyl

0.008

0.8

28 June 1999

2–year dietary rat study; a NOAEL of 0.8 mg/kg bw/d was based on histopathological changes in the liver and kidneys at the next higher dose.

 

Oxadiazon

0.05

5

17 August 1989

   

Oxadixyl

0.01

1.3

2 June 1988

   

Oxamyl

0.002

0.2

18 May 1993

   

Oxathiapiprolin

4

411

30 July 2015

2–gen reproduction rat study; a NOAEL of 411 mg/kg bw/d was based on increased interval to preputial separation in males at the next higher dose.

 

Oxfendazole

0.005

0.5

8 October 1990

   

Oxibendazole

0.01

10

2 June 1998

3–month capsule fed dog study; a NOAEL of 10 mg/kg bw/d was based on reduced food consumption, reduced body weight gains and reduced testes weights at the next higher dose.

 

Oxycarboxin

0.15

15

15 August 1979

   

Oxyclozanide

0.002

5

18 March 1976

   

Oxydemeton-methyl

0.0003

0.027

16 December 1997

2–year dietary rat study; a NOAEL of 0.027 mg/kg bw/d was based on inhibition of plasma and RBC cholinesterase activity at the next higher dose.

 

Oxyfluorfen

0.025

2.5

5 August 1982

2–year dietary rat study; a NOAEL of 2.5 mg/kg bw/d was based on reduction in thyroid weight and hepatocyte enlargement at the next higher dose.

 

Oxytetracycline

0.03

0.033

10 October 2016

Long history of safe use in human medicine.

Selection of resistant bacterial strains appears to be the most sensitive end-point for use in risk assessment. As humans show little variation with respect to this effect, JECFA concluded that no uncertainty (safety) factor was needed (JECFA-02).

P

Paclobutrazol

0.01

1.4

10 February 1988

2–year dietary rat study; a NOAEL of 1.4 mg/kg bw/d was based on hepatocellular effects, reduction in bodyweight gain and reduced serum triglyceride levels at the next higher dose.

 

Paraquat (as cation)

0.004

0.45

27 June 2003

1–year dietary dog study; a NOAEL of 0.45 mg/kg bw/d was based on pulmonary lesions at the next higher dose.

 

Pebulate

0.007

0.7

5 December 1990

   

Penconazole

0.007

0.71

6 February 1986

   

Pencycuron

0.02

2

23 May 1994

   

Pendimethalin

0.1

12.5

18 February 1987

2–year dietary dog study; a NOAEL of 12.5 mg/kg bw/d was based on increased serum alkaline phosphatase, liver weight and hepatic lesions at the next higher dose.

 

Penflufen

0.02

4 [LOAEL]

10 October 2012

2–year dietary rat study; based on an increased incidence of histiocytic sarcomas at the lowest tested dose 4 mg/kg bw/d.

 

Penthiopyrad

0.1

11

1 February 2012

2–gen reproduction rat study; a NOAEL of 11 mg/kg bw/d was based on reduced body weight gain, increased adrenal weight and an increased incidence of cortical hypertrophy at the next higher dose.

 

Permethrin

0.05

5

29 May 1986

2–year dietary rat study; a NOAEL of 5 mg/kg bw/d was based on clinical signs, body and ovarian weights and clinical chemistry findings at the next higher dose. 1–year dietary dog study; a NOAEL of 5 mg/kg bw/d based on reduced body weight gain at the next higher dose.

 

Phenmedipham

0.03

3.4

13 April 2011

1–year dietary rat study; a NOAEL of 3.4 mg/kg bw/d was based on reduced RBC, Hct, Hb and haemosiderin deposition in the liver at the next higher dose.

 

d-Phenothrin

0.05

5

1988

1–year dietary dog study; a NOAEL of 5 mg/kg bw/d was based on hepatocellular hypertrophy and focal degeneration of the adrenal cortex at the next higher dose.

 

Phenothrin

0.02

2.5

10 February 1988

   

Phorate

0.0005

0.05

30 August 1991

   

Phosmet

0.01

1

12 November 1987

   

Picloram

0.07

7

18 February 1987

6–month dietary dog study; a NOAEL of 7 mg/kg bw/d was based on increased relative liver weight at the next higher dose.

 

Picolinafen

0.007

1.4 [LOAEL]

1 August 2000

1–year dietary dog study; based on reduced body weight gain at the lowest tested dose of 1.4 mg/kg bw/d.

 

Pinoxaden

0.1

10

29 August 2005

2–year dietary rat study; a NOAEL of 10 mg/kg bw/d based on reduced serum phosphate levels and thymus atrophy at higher doses.

 

Piperonyl butoxide

0.1

16

20 March 1997

1–year dietary dog study; a NOAEL of 16 mg/kg bw/d was based on reduced body weight gain, liver hypertrophy and increased plasma AP activity at the next higher dose.

 

Pirimicarb

0.002

0.4

10 September 1987

3–month dietary dog study; a NOAEL of 0.4 mg/kg bw/d was based on a slight increase in megalobasts (large, abnormally developed red blood cells) in the bone marrow at the next higher dose.

 

Pirimiphos-methyl

0.02

0.25 (H)

30 August 1991

   

Porcine gonadotrophins

   

25 June 2002

 

ADI considered to be unnecessary due to its low oral toxicity.

Porcine somatotropin

   

29 August 1991

 

ADI considered to be unnecessary due to its low oral toxicity.

Prallethrin

0.02

2.5

18 January 1993

1–year capsule fed dog study; a NOAEL of 2.5 mg/kg bw/d was based on increased deposition of lipofuscin in kidney and bladder at the next higher dose.

 

Praziquantel

0.02

20

22 June 1995

13–week capsule fed dog study; a NOAEL of 20 mg/kg bw/d was based on increased relative liver and thyroid weights at the next higher dose.

 

Prochloraz

0.01

1

5 August 1982

   

Procymidone

0.03

2.5

13 December 2004

1–gen reproductive rat study; a NOAEL of 2.5 mg/kg bw/d was based on increased (parental) testes weights and reduced epididymides and prostate weights at the next higher dose.

 

Prodiamine

0.05

5

22 December 1994

   

Profenofos

0.0001

0.0072

4 February 1982

6–month dietary dog study; a NOAEL of 0.0072 mg/kg bw/d was based on a reduction in plasma cholinesterase activity at the next higher dose.

 

Profoxydim

0.05

5

29 November 2006

2–year dietary rat study; a NOAEL of 5 mg/kg bw/d was based on decreased alkaline phosphatase and cholesterol levels and mild anaemia (reduced Hct, RBC, and Hb) at the next higher dose.

 

Prohexadione-calcium

0.2

20

20 December 2007

2–year dietary rat study; a NOAEL of 18.5 mg/kg bw/d was based on reduced bodyweight gain and food conversion efficiency, abnormal haematology, clinical chemistry and thyroid histopathology at the next higher dose. 1–year dietary dog study; a NOAEL of 20 mg/kg bw/d was based on abnormal haematology, clinical chemistry and renal histopathology at the next higher dose.

 

Prometryn

0.03

3

17 May 1990

   

Propachlor

0.02

2

11 August 1988

   

Propamocarb

0.4

39

26 November 2015

1–year dietary dog study; a NOAEL of 39 mg/kg bw/d was based on vacuolization in epididymes, lacrimal glands, lymph nodes, oesophageal glands, salivary glands and uterine cervix at the next higher dose.

 

Propanil

0.2

20

19 February 1981

   

Propaquizafop

0.003

0.3

26 November 1992

   

Propargite

0.002

2

17 June 1999

20–month dietary rat study; a NOAEL of 2 mg/kg bw/d was based on a transient cell proliferative response (increased jejunal smooth muscle cells) at the next higher dose.

 

Propazine

0.02

1.5

16 June 1986

3–month dietary dog study; a NOAEL of 1.5 mg/kg bw/d was based on reduced body weight at the next higher dose.

 

Propetamphos

0.001

0.1

14 February 1985

6–month dietary dog study; a NOAEL of 0.1 mg/kg bw/d was based on a reduction of plasma and RBC cholinesterase activity at the next higher dose.

 

Propiconazole

0.04

4

5 May 1983

2–year dietary rat study; a NOAEL of 4 mg/kg bw/d was based on reduced body weight at the next higher dose.

 

Propineb

0.0005

0.05 for PTU

15 February 2007

2–year dietary rat study; a NOAEL of 0.05 mg/kg bw/d was based on increased cholesterol levels and increased plasma protein levels at the next higher dose.

The ADI for propineb is a group value, which includes propineb and its impurity/metabolite propylene thiourea (PTU).

Propoxur

0.02

0.2

5 November 1986

   

Propylene oxide

0.006

2.9

24 July 2006

124–week inhalation rat study; a NOAEL of 30 ppm (equivalent to NOAEL of 2.9 mg/kg bw/d) was based on reduced body weight gain and increased mortality at the next higher dose.

 

Propylene thiourea (PTU)

0.0005

0.05

2 December 1988

   

Propyzamide

0.02

1.9

7 July 1994

2–year dietary mouse study; a NOAEL of 1.9 mg/kg bw/d was based on hepatocellular tumour incidence at the next higher dose.

 

Proquinazid

0.01

1.2

6 December 2011

2–year dietary rat study; a NOAEL of 1.2 mg/kg bw/d was based on alteration/degeneration, cholangiofibrosis, fatty change, hyperplasia of oval cells and/or bile ducts at the next higher dose.

 

Prosulfocarb

0.02

1.9

21 August 2006

2–year dietary rat study; a NOAEL of 1.9 mg/kg bw/d was based on reduced bodyweight gain at the next higher dose.

 

Prothioconazole

0.01

1.1

28 March 2006

2–year dietary rat study; a NOAEL of 1.1 mg/kg bw/d was based on increased liver weight, hepatocellular hypertrophy and liver vacuolation with fatty change at the next higher dose.

Since the residue definition for risk assessment in all commodities is expressed as prothioconazole-desthio and this metabolite is of higher toxicity than the parent, a group ADI was established to include prothioconazole-desthio.

Prothiofos

0.0001

0.01

29 October 1993

   

Pydiflumetofen

0.1

10

21 February 2017

1–year dietary rat study; a NOAEL of 10 mg/kg bw/d was based on reduced body weight gain, food consumption and food energy conversion efficiency at the next higher dose.

 

Pymetrozine

0.006

0.57

8 December 2000

1–year dietary dog study; a NOAEL of 0.57 mg/kg bw/d was based on anaemia and increased blood prothrombin (clotting) time, plasma cholesterol and phospholipid level at the next higher dose.

 

Pyraclofos

0.001

0.1

29 August 1991

   

Pyraclostrobin

0.03

3

26 June 2008

2–year dietary rat study; a NOAEL of 3 mg/kg bw/d was based on reduced body weight gain at the next higher dose.

 

Pyraflufen-ethyl

0.2

20

17 December 2004

18–month dietary mouse study; a NOAEL of 20 mg/kg bw/d was based on increased liver weight at the next higher dose. 2–year dietary rat study; a NOAEL of 20 g/kg bw/d was based on increased urinary volume and relative kidney weight and decreased specific gravity in the urine at the next higher dose. Developmental rabbit study; a NOAEL of 20 mg/kg bw/d was based on increased mortality at the next higher dose.

 

Pyrasulfotole

0.01

1

19 October 2007

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on corneal and retinal lesions, increased liver weight, centrilobular hepatocellular hypertrophy and increased plasma cholesterol at the next higher dose.

 

Pyrethrins (pyrethrum extracts)

0.04

4

21 October 2003

2–year dietary rat study; a NOAEL of 40 mg/kg bw/d was based on an increased incidence of benign tumours of the skin, liver and thyroid observed at the next higher dose.

JMPR'03

Pyridaben

0.01

1

13 August 1992

 

 

Pyrimethanil

0.2

17

1 November 1995

2–year dietary rat study; a NOAEL of 17 mg/kg bw/d was based on reduced body weight gain and food consumption at the next higher dose.

 

Pyriofenone

0.09

9

26 November 2014

1–year dietary rat study; a NOAEL of 9 mg/kg bw/d was based on changes indicative of altered liver function; a decrease in bilirubin and a decrease in alkaline phosphatase at the next higher dose. 2–year dietary rat study; a NOAEL of 9 mg/kg bw/d was based on increased incidence of chronic nephropathy of the kidneys at the next higher dose.

 

Pyriproxyfen

0.07

7

11 March 1994

2–year dietary rat study; a NOAEL of 7 mg/kg bw/d was based on reduced bodyweight gain, transient increases in clinical chemistry parameters and increased relative liver weight at the next higher dose.

 

Pyrithiobac sodium

0.2

21

18 May 1995

18–month dietary mouse study; a NOAEL of 21 mg/kg bw/d was based on elevated peroxisomal beta-oxidation rates at the next higher dose.

 

Pyroxasulfone

0.02

2

10 February 2017

1–year capsule fed dog study; a NOAEL of 2 mg/kg bw/d was based on impaired hind limb function, ataxia, hind limb twitching and tremors at the next higher dose.

 

Pyroxsulam

1

100

14 April 2008

18–month dietary mouse study, a NOAEL of 100 mg/kg bw/d was based on increased absolute and relative liver weight associated with histopathological changes (increased incidence of clear cell foci of alteration) at the next higher dose.

 

Q

Quinclorac

0.3

35

13 September 2004

1–year dietary dog study; the NOAEL of 35 mg/kg bw/d was based on reduced food conversion efficiency, lower plasma creatinine levels and increased kidney weight at the next higher dose.

 

Quinoxyfen

0.2

20

15 January 2002

2–year dietary rat study; a NOAEL of 20 mg/kg bw/d was based on increased organ weights, increased incidence of severe chronic progressive glomerulonephropathy and enhanced growth of testicular tumours at the next higher dose. 1–year dietary dog study; a NOAEL of 20 mg/kg bw/d was based on reduced body weight gain, increased liver weight, liver pathological changes and anaemia at the next higher dose.

 

Quintozene

0.007

0.7

10 September 1987

   

Quizalofop-ethyl

0.01

1.25

12 November 1987

   

Quizalofop-P-tefuryl

0.01

1.3

14 November 1996

2–year dietary rat study; a NOAEL of 1.3 mg/kg bw/d was based on the induction of peroxisome proliferation with accompanying histopathological changes in the liver and tumourigenesis in the liver and testis at the next higher dose.

 

R

Ractopamine

0.001

0.125

30 July 2002

1–year gavage monkey study; a NOAEL of 0.125 mg/kg bw/d was based on increased heart rates and lower relative heart weight at the next higher dose. Single-dose human study; a NOAEL of 0.133 mg/kg bw/d was based on increased heart rate and cardiac output at the next higher dose.

 

Rimsulfuron

0.02

1.6

24 June 1997

1–year dietary dog study; a NOAEL of 1.6 mg/kg bw/d was based on biochemical changes, reduced body weight gain and testicular degeneration at the next higher dose.

 

Robenidine

0.005

10

17 September 1997

2–year dietary dog study; a NOAEL of 10 mg/kg bw/d was based on increased liver weight at the next higher dose.

 

S

Saccharomyces cerevisiae

   

4 September 2002

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Saflufenacil

0.05

5

13 February 2017

18–month dietary mouse study; a NOAEL of 5 mg/kg bw/d was based on microcytic hypochromic anaemia at the next higher dose.

 

Salinomycin

0.01

1

12 November 1981

 

 

Semduramicin

0.003

0.3

11 June 1997

1–year dietary dog study; a NOAEL of 0.3 mg/kg bw/d was based on increased blood urea nitrogen, plasma ALT and SDH levels and WBC counts, hypertension and ocular changes at the next higher dose.

 

Sethoxydim

0.18

18

5 August 1982

   

Siduron

0.025

2.5

2 March 1994

   

Simazine

0.005

0.5

5 December 1990

   

Spectinomycin

1

100

5 August 1983

   

Spinetoram

0.06

6

5 May 2008

28–day dietary dog study; a NOAEL of 6 mg/kg bw/d was based on reduced food consumption and body weight gain, vacuolization of macrophages, multifocal bone marrow necrosis and non-regenerative anaemia at the next higher dose.

 

Spinosad

0.02

2.4

2 May 1997

2–year dietary rat study; a NOAEL of 2.4 mg/kg bw/d was based on thyroid vacuolation at the next higher dose.

 

Spiramycin

0.75

75

9 February 1978

   

Spirotetramat

0.05

5

18 August 2008

1–year dietary dog study; a NOAEL of 5 mg/kg bw/d was based on an increased incidence of thymus involution at the next higher dose.

 

Spiroxamine

0.02

2.5

2 July 2001

1–year dietary dog study; a NOAEL of 2.5 mg/kg bw/d was based on  enlarged liver cells (hepatocytomegaly) and eye changes (cataracts and lenticular opacity) and mild anaemia (reduced RBC, Hb and Hct) at the next higher dose.

 

Streptomycin (and dihydrostreptomycin)

0.05

5 (JECFA '97)

28 June 2001

2–year dietary rat study; a NOAEL of 5 mg/kg bw/d was based on decreased body weight gains at the next highest dose of 10 mg/kg bw/d dihydrostreptomycin.

NOAEL based on a study performed with dihydrostreptomycin due to the close relatedness of the two drugs.

Streptomyces lydicus

   

7 June 2016

 

ADI unnecessary. Naturally occurring organism - residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

Sulfadiazine

0.02

37.5

20 May 1993

   

Sulfadimidine

0.02

2

20 May 1993

   

Sulfadoxine

0.05

50

22 May 1995

3–month gavage monkey study; a NOAEL of 50 mg/kg bw/d was based on increased liver weights at the next higher dose.

 

Sulfaquinoxaline

0.01

1

24 July 1997

3–month dietary dog study; a NOAEL of 1 mg/kg bw/d was based on increased thyroid weights at the next higher dose.

 

Sulfometuron-methyl

0.02

2.5

29 August 1991

   

Sulfosulfuron

0.2

24

19 December 1997

2–year dietary rat study; a NOAEL of 24 mg/kg bw/d was based on induced pathology in the kidneys and urinary bladder and associated biochemical and urinary findings at the next higher dose.

 

Sulfoxaflor

0.04

4.24

27 June 2013

2–year dietary rat study; a NOAEL of 4.24 mg/kg bw/d was based on increased serum cholesterol and histopathological liver effects at the next higher dose.

 

Sulfur dioxide and equivalents (metabisulfites, sulfites, hydrogensulfites, thiosulfites)

0.7

JECFA'98

28 February 1998

   

Sulfuryl Fluoride

0.01

20 ppm

25 August 2006

2–year inhalation rat study; a NOAEL of (20 ppm) (approximately equivalent to a systemic exposure at 1.4 mg/kg bw/d) was based on effects on the kidney, brain, bone and survival at the next higher dose.

 

T

Tebuconazole

0.03

2.96

27 August 2010

1–year dietary dog study; a NOAEL of 2.96 mg/kg bw/d was based on lenticular opacity and histopathological effects in the adrenals (hypertrophy of zona fasciculata cells) at the next higher dose.

 

Tebufenozide

0.02

1.8

9 October 1996

2–gen reproduction rat study; a NOAEL of 1.8 mg/kg bw/d for parental toxicity was based on histopathological lesions in the spleen (congestion, pigment, and extra-medullary haematopoiesis) at the next higher dose.

 

Tebufenpyrad

0.002

0.2

15 January 1993

   

Tebuthiuron

0.07

7

14 February 1985

2–gen reproduction rat study; a NOAEL of 7 mg/kg bw/d was based on reduced body weight gain in adults and pups at the next higher dose.

 

Temephos

0.1

1 (H)

10 February 1988

4–week human study; a NOAEL of 1 mg/kg bw/d was based on a reduction in plasma cholinesterase activity and clinical signs at the next higher dose.

 

Tepraloxydim

0.05

5

19 May 2002

2–year dietary rat study; a NOAEL of 5 mg/kg bw/d was based on increased ovary weights and increased incidence of ovarian cysts at the next highest dose of 600  pm.

 

Terbacil

0.06

6.25

12 November 1987

   

Terbufos

0.0002

0.0025

26 November 1992

   

Terbuthylazine

0.003

0.35

4 May 2001

2–year dietary rat study; a NOAEL 0.35 mg/kg bw/d was based on reduced body weight gain and food consumption at the next higher dose.

 

Terbutryn

0.1

10

29-May-86

   

Tetraconazole

0.004

0.4

12 December 2002

2–year dietary rat study; a NOAEL of 0.4 mg/kg bw/d was based on histopathological changes in the liver (hepatocyte enlargement, eosinophilic hepatocytes, cystic degeneration and bile duct hyperplasia) at the next higher dose.

 

Tetramethrin

0.02

2

14 August 1992

2–year dietary mouse study; a NOAEL of 2 mg/kg bw/d was based on reduced pituitary and thyroid/parathyroid weight at the next higher dose.

 

Thiabendazole

0.3

3 (H)

2 June 1988

24–week capsule human study; a NOAEL of 3 mg/kg bw/d was based on an absence of any adverse effects at this dose (the highest tested).

 

Thiacloprid

0.01

1.2

20 July 2001

2–year dietary rat study; a NOAEL of 1.2 mg/kg bw/d was based on liver toxicity and thyroid changes (follicular epithelial hypertrophy) secondary to liver enzyme induction at the next higher dose.

 

Thiamethoxam

0.02

2

14 April 2000

2–generation reproduction rat study; a NOAEL of 2 mg/kg bw/d was based on lower bodyweight gains in the pups at the next higher dose.

 

Thidiazuron

0.02

2.5

20 June 1991

   

Thiobencarb

0.007

0.75

10 November 1977

   

Thiodicarb

0.03

3

5 August 1983

2–year dietary rat study; a NOAEL of 3 mg/kg bw/d was based on increased incidence of pituitary cysts at the next higher dose. 2–year dietary mouse study; a NOAEL of 3 mg/kg bw/d based on increased mortality at the next higher dose.

 

Thiophanate-methyl

0.08

8

15 February 2011

 1–year oral capsule fed dog study; a NOAEL of 8 mg/kg bw/d was based on thyroid hyperplasia observed at the next higher dose. 2–year dietary rat study; a NOAEL of 8 mg/kg bw/d was based on thyroid hyperplasia and thyroid tumours

 

Thiram

0.004

0.4

30 March 1995

2–year dietary dog study; a NOAEL of 0.4 mg/kg bw/d was based on neurological disturbances, anaemia and changes in the liver at the next higher dose.

 

Tilmicosin

0.002

4

13 August 1992

1–year capsule fed dog study; a NOAEL of 4 mg/kg bw/d was based on reduction in bodyweight gain at the next higher dose.

 

Tolclofos-methyl

0.05

5

10 February 1988

   

Tolfenamic acid

0.005

0.5 (H)

16 January 2001

Single dose human therapeutic study; a LOAEL of 0.5 mg/kg bw/d was based on the lowest effective therapeutic (antipyretic) dose in humans.

 

Toltrazuril

0.01

1

4 January 1993

   

Topramezone

0.004

0.4

16 June 2016

2–year dietary rat study; a NOAEL of 0.4 mg/kg bw/d was based on effects in the eye (corneal opacity and chronic keratitis), increased kidney weights and an increased incidence of thyroid lesions (diffuse follicular cell hypertrophy, follicular cell hyperplasia and adenoma/carcinoma) at the next higher dose. Supported by two studies: 2–gen reproduction rat study; a NOAEL of 0.4 mg/kg bw/d was based on corneal opacity, increased liver, kidney and thyroid weights at the next higher dose. Developmental rabbit study; a NOAEL of 0.4 mg/kg bw/d was based on incomplete ossification at the next higher dose.

 

Tralkoxydim

0.005

0.5

29-Aug-91

   

Transfluthrin

0.003

0.25

16 October 1995

53–week dietary dog study; a NOAEL of0.25 mg/kg bw/d was based on the absence of treatment-related changes at 0.25 mg/kg bw/d.

 

Triadimefon

0.03

2.5

18 February 1987

   

Triadimenol

0.06

6.25

2 June 1988

2–year dietary rat study; a NOAEL of 6.25 mg/kg bw/d was based on reduced body weight gain, increased liver enzyme activity (ALT, AST, glutamate dehydrogenase) at the next higher dose.

 

Triallate

0.005

0.5

1 December 1988

2–year dietary rat study; a NOAEL of 0.5 mg/kg bw/d was based on reduced liver weight and testicular changes at the next higher dose.

 

Triasulfuron

0.005

0.5

14 February 1991

   

Tribenuron-methyl

0.01

0.95

15 April 1994

   

Trichlorfon

0.002

0.2

29 May 1986

10–year dietary monkey study; a NOAEL of 0.2 mg/kg bw/d was based on reduced plasma and RBC cholinesterase activity, haematological and thyroid wt effects at the next higher dose.

 

Triclabendazole

0.002

0.15

23 May 1996

2–generation gavage rat study; a NOAEL of 0.15 mg/kg bw/d was based on increased pup mortality at the next higher dose.

 

Triclopyr

0.005

0.5

5 November 1986

1–year dietary dog study; a NOAEL of 0.5 mg/kg bw/d was based on reduced phenolsulfonphthalein excretion, increased plasma BUN and creatinine at the next higher dose.

 

Trifloxystrobin

0.05

5

29 September 1998

1–year capsule fed dog study; a NOAEL of 5 mg/kg bw/d was based on increased absolute and relative liver weights, hepatocellular hypertrophy, biochemical changes, diarrhoea, reduced food consumption and reduced weight gain at the next higher dose.

 

Trifloxysulfuron

0.2

15

19 May 2002

1–year dietary dog study; a NOAEL of 15 mg/kg bw/d was based on increased liver weight, decreased bilirubin and atrophy in the thymus at the next higher dose.

 

Triflumuron

0.007

0.7

2 June 1988

   

Trifluralin

0.02

2.5

30 August 1991

   

Triforine

0.02

2.7

10 September 1987

   

Trimethoprim

0.02

33

20 May 1993

   

Trinexapac-ethyl

0.01

1.4

14 December 1993

1–year dietary dog study; a NOAEL of 1.4 mg/kg bw/d was based on reduced testes and uterine weights at the next higher dose.

 

Triticonazole

0.02

2

13 January 1997

13–week dietary rat study; a NOAEL of 2 mg/kg bw/d was based on histopathology of the adrenal cortex at the next higher dose. 1–year dietary dog study; a NOAEL of 2.5 mg/kg bw/d was based on adverse effects on the liver (clinical chemistry and enlargement) at the next higher dose.

 

Tulathromycin

0.005

(M)

11 August 2006

A microbiological ADI was established at 0.005 mg/kg bw/d based on a MIC50 of 1 μg/mL in the most sensitive bacterial genus, Bifidobacterium spp found in the human GI tract.

 

Tylosin

0.3

30

15 January 1993

2–year dietary rat study; a NOAEL of 30 mg/kg bw/d was based on pituitary tumours at the next higher dose.

 

U

Ulocladium oudemansii

 

 

12 December 2003

 

ADI unnecessary. Naturally occurring organism—residues from its use are unlikely to be distinguishable from naturally occurring background levels of the organism.

 

Uniconazole-P

0.02

1.86

3 February 2000

2–year dietary rat study; a NOAEL of 1.86 mg/kg bw/d was based on increased liver weight in association with centrilobular hepatocyte enlargement and vacuolation at the next higher dose

 

V

Virginiamycin

0.2

25

10 February 1988

2–year dietary rat study; a NOAEL of 25 mg/kg bw/d was based on increased testicular weights at the next higher dose.

 

Z

Zeranol

0.0002

0.015

10 February 1988

   

Zeta-cypermethrin

0.07

7

23 May 1996

2–gen reproduction rat study; a NOAEL of 7 mg/kg bw/d was based on reduced bodyweight gain and feed consumption in females during the premating and lactation periods at the next higher dose. Pups also displayed reduced bodyweight gain and clinical signs at the next higher dose.

 

Zilpaterol

0.00004

0.00076[LOAEL]

24 October 2016

Single dose human study; a LOAEL of 0.05 mg/person (equal to 0.00076 mg/kg bw) was based on the observation of tremors at the lowest tested dose.

 

Zineb

0.005

5

27 November 1992

   

Ziram

0.01

1

21 June 1995

2–year dietary rat study; a NOAEL of 1 mg/kg bw/d was based on atrophy of skeletal muscle at the next higher dose.

 

 

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