For public consultation: Generation of storage stability data for agricultural chemical products

Agricultural chemical products can undergo chemical and physical changes on storage. The rate at which these changes occur depends on the nature of the active constituent(s), the non-active components, the formulation type, the packaging and, notably, the storage conditions (temperature, light and humidity). The product remains fit for use as long as these changes have no adverse effects on application, biological performance, the safety of operators, consumers and the environment.

This guideline provides a comprehensive guide to the conduct of stability testing for agricultural chemical products. The APVMA stability testing guideline has been constructed to closely follow the Manual on the development and use of FAO and WHO specifications for pesticides (JMPS 2010) (FAO/WHO pesticide specifications). The OECD Guidance Document for Storage Stability Testing of Plant Protection and Biocidal Products is also noted, however it provides a high level overview of storage stability data and is not an alternative or replacement for this guideline.

1. Generating storage stability data

Storage stability data should be generated with the product stored in the proposed commercial packaging (or smaller packages of the same construction and material) under accelerated conditions and/or real time testing at room temperature or under ambient warehouse conditions. The following information regarding the storage stability trials should be supplied to the APVMA:

  • product specifications, with proposed limits for the content of active constituent and physical characteristics of the product within which the properties of the product will remain during its proposed shelf life
  • test results generated before and after storage, with full details of the methods used for each of the test parameters listed in the shelf-life specifications
  • stability of the packaging materials showing no significant deterioration, as interaction with the product can cause brittleness, softening, and corrosion.

Unlike veterinary products, most agricultural products are not date controlled under APVMA legislation. For the bulk of agricultural chemical products, the data should confirm that the formulated product will remain within specification for at least two years, when stored in its unopened original container, away from direct sunlight, at or above 25 ˚C (‘normal storage conditions’).

Products containing some agricultural active constituents are designated as data controlled products under legislation, have approved shelf lives, and must carry expiry dates on the label. For further information, see the separate guideline on date-controlled agricultural chemical products. For a product not designated as date controlled, a shelf life less than two years (including an expiry date on the label) may be approved where the data are not sufficient to confirm that the product will remain within specification for at least two years under normal storage conditions.

1.1. Pack sizes and pack size changes

As specified below in section 2, design of stability testing trials for new products should be conducted on product packaged in the same containers (materials and pack size) that are proposed for the final marketing of the product. Smaller containers of the same material as the commercial containers may be used for the stability testing where the size of the commercial container makes stability testing impractical.  

Applicants may also wish to market their products in a smaller container at a later date, therefore undertaking the stability study in a smaller container of the same material and construction would demonstrate the product pack is fit for purpose for not only the current marketed product size but for future, smaller pack sizes.

Packaging size (net contents) is a relevant particular for products under APVMA legislation, and new pack sizes outside the range currently registered require an application for variation of the product registration. Depending on the situation, stability data may be required to support the new pack size(s).

1.1.1. Increased pack sizes

The APVMA does not require additional stability data for an increase in primary pack size from that used in the stability study. The surface area to volume ratio of the product reduces as the primary pack size increases, and the interactions between the product and packaging become less significant.

Larger pack sizes may have implications for other assessment areas (e.g. worker safety or environmental impact), and data or argument may be required.

The packaging for an increase of container size must still meet the conditions of registration for containers in terms of having sufficient strength to prevent leakage and must be of a practical size to allow users to comply with any label instructions such as “shake well before use”.

1.1.2. Decreased pack sizes

Smaller pack sizes have a greater ratio of surface area to volume than larger containers, interactions between the product and packaging are generally more significant, and stability data or scientific argument in lieu of data may be required to support a smaller pack size.

The APVMA will consider approval of a pack size that is 50 per cent smaller (by volume or by weight) than the pack size used to generate the stability studies provided for a product without provision of further stability data, provided there are no known stability problems with the active constituents and/or formulation in question. For example, it is very unlikely that a smaller pack size of a date controlled product would be supported without further stability data.  

In addition, where there is a long history of use for other registered products with the same formulation type and active constituent in smaller pack sizes (for example, soluble concentrates containing 450 g/L glyphosate as the isopropylamine salt), it may also be possible to support a smaller pack size without stability data, basing a scientific argument on the registration history of similar products in smaller packs.  

1.2. Changes to packaging material

Stability data should be generated for the product stored in the proposed packaging. When it is proposed to use multiple packaging materials, or where the reference product used a different packaging material even with an identical formulation, stability data should generally be provided for product in each packaging material.

However, it is recognised that certain packaging materials are more resilient to chemical degradation and interaction with the product than others. Where stability of a formulation has already been demonstrated for a particular packaging material, and it is proposed to change to a packaging material known to be more resistant to chemical degradation, stability data will not be required.

1.2.1. Liquid formulations

Water based formulations, e.g. aqueous soluble concentrates and suspension concentrates
Packaging used in the stability study Acceptable extrapolations
Any other than metal All packaging types other than metal are supported with no further data
Organic solvent based formulations, e.g. emulsifiable concentrates, non-aqueous soluble concentrates
High density polyethylene (HDPE) HDPE/EVOH, fluorinated HDPE and HDPE/polyamide packs are supported with no further stability data
HDPE/EVOH or fluorinated HDPE or HDPE/ polyamide Full stability data from one of these three packaging types can be extrapolated to one of the others, or to plain HDPE, with the provision only of ‘seepage data’, i.e. packaging stability data, which requires only observation of the effects on the packaging during storage, not testing against all the product specifications.

1.2.2. Solid formulations

Extrapolation is possible between all container types except:

  • to or from packaging involving water-soluble bags; and
  • from rigid to flexible containers for granular products due to potential issues with crushing of the granules if containers are stacked.

For registered products, the packaging material (unlike pack size) is not a relevant particular automatically requiring an application to APVMA for variation of registration if it is changed. However, registrants should note that under Regulation 18 of the Agvet Code Regulations, it is a condition of registration that products must only be supplied in containers that meet the following requirements:

  1. be impervious to, and incapable of chemical reaction with, its contents when under conditions of temperature and pressure that are likely to be encountered in normal service; and
  2. have sufficient strength and impermeability to prevent leakage of its contents during handling, transport and storage under normal handling conditions; and
  3. if it is intended to be opened more than once—be able to be securely and readily closed and reclosed; and
  4. have sufficient excess capacity to prevent it from breaking if its contents expand during handling, transport or storage; and
  5. enable all or any part of its contents to be removed or discharged in such a way that, with the exercise of no more than reasonable care, the contents cannot:
    1. harm any person; or
    2. have an unintended effect that is harmful to the environment.

Changes to packaging materials for registered products that comply with extrapolations allowed in 1.2.1 and 1.2.2 above would comply with the condition of registration imposed by Regulation 18. However, if a change was not covered by the extrapolations outlined in 1.2.1 and 1.2.2, it may not allow APVMA to remain satisfied with respect to the safety criteria for the product, and an application to vary the packaging should be made with appropriate stability data.

1.3. Shelf-life statement on the product label

The printed labels should include the date (month and year) of manufacture of the batch and relevant information on the conditions under which the product should be stored. For agricultural chemical products, an expiry date is normally only given on the product label if the product cannot be stored for at least two years at or above 25 ˚C, or the product is date controlled under APVMA legislation. A list of date-controlled products is available in the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations) and further information is available in the date-controlled agricultural chemical products guideline.

2. Design of stability testing trials

2.1. Size and number of batches

Stability testing should be conducted on laboratory-, pilot- or production-scale batches of the product stability. Batch sizes of less than 5 kilograms or 5 litres are normally not acceptable for use in stability testing, except when this is the size of a normal production batch. The formulation is to be the same as that proposed for registration in Australia.

Please include the following information in a stability study:

  • product name
  • batch identity
  • batch size
  • date of manufacture
  • containers used for storage of the samples during the study (size, construction material and type of container).

2.2. Storage conditions and duration

Storage stability trials may include accelerated or real-time tests, or both. Real-time testing is generally conducted for a product that may be unstable at high temperature, and is generally a requirement for date controlled products. For example, products containing microbial active constituents are date controlled and are not generally stable at the elevated temperatures typically used for accelerated testing, and real time testing is almost always necessary.

For some formulations, studies at lower temperatures may be necessary due to the instability of the formulation at higher temperatures (this should be reflected in the recommended storage conditions).

Liquid formulations should also be tested at low temperatures (0 ± 2 ˚C or lower). This is to demonstrate that the product has not changed, for example, that specific components do not crystallise or separate out at low temperature.

For capsule suspension products, freeze-thaw cycling testing should be performed in order to confirm that the integrity of the capsules will not be adversely affected by freezing and re-thawing.

2.3. Accelerated testing

Stability tests at elevated temperatures are designed to increase the rate of chemical degradation or physical change of a product. Testing is performed at elevated temperatures to obtain information on the shelf life of a product in a shorter time than a real time study of two years. Accelerated testing involves extrapolations from higher to lower temperatures and from shorter to longer storage periods.

The FAO/WHO pesticide specifications recommend testing of the relevant product parameters before and after storage at 54 ˚C for 14 days so that a comparison can be made to determine the change during storage. In some situations, one of the alternative time-temperature regimes listed in Table 1 may be used. For example, aerosol products are commonly tested at 40 ˚C for 8 weeks due to safety issues with exposure to temperatures above 50 ℃.

Table 1: Accelerated storage temperatures and duration of stability trials
Temperature Duration Comments
54 ˚C 14 days Generally preferred testing regime (CIPAC MT 46.3)
50 ˚C 4 weeks  
45 ˚C 6 weeks  
40 ˚C 8 weeks Commonly used for aerosol products.
35 ˚C ±2 ˚C 12 weeks  
30 ˚C ±2 ˚C 18 weeks  

FAO/WHO pesticide specifications page number 63.

Products that exhibit an adequate stability profile at 54 ˚C to 40 ˚C are likely to be stable for at least two years under normal storage conditions (at or above 25 ˚C).  

Appropriate justification should be provided for use of a temperature regime other than 2 weeks at 54 ℃ (or 8 weeks at 40 ℃ for aerosols). This is particularly important for the two lowest temperature regimes, where summer temperatures, particularly in northern areas, commonly reach 30-35 ℃. Part of the justification may include lower recommended storage temperatures.

It is recommended that samples of the formulation be taken before and after the MT 46.3 test. The two samples (time zero and time 14 days (for 54 ˚C trials)) may be analysed concurrently after the test. This will reduce the analytical error of two separate analyses on different days, and perhaps by different analysts.

2.4. Real-time testing

Stability tests at elevated temperatures are intended to increase the rate of chemical degradation or the physical change of a product. Data from an accelerated study can give a useful indication of a product’s stability, but in some cases products may pass this test and yet still be unstable on long-term storage.

Therefore, in certain situations, stability data generated at ambient temperatures over a period of two years (real-time testing) may be more appropriate than accelerated testing. For example, if the proposed product has a tendency to cake over time or is subject to contamination as a result of bacterial or fungal growth, accelerated testing would not be suitable to demonstrate the product’s stability, and real-time testing should be conducted. Real-time data are almost always required for date-controlled agricultural chemical products.

Real-time testing is normally performed at or above 25 ˚C with storage for at least two years. Testing should at least be conducted at time zero and at the end of the storage period. However, applicants may wish to consider testing the product additionally at intermediate time points (e.g. after six, 12 and 18 months storage for a two year study), particularly if the period of stability of the product is in doubt.

Depending on the formulation type and packaging material, testing under standardised relative humidity and light exposure conditions may also be recommended.

2.5. Low temperature stability testing

Liquid formulations (capsule suspensions, emulsifiable concentrates, oil-in-water emulsions, micro- emulsions, soluble concentrates, suspension concentrates) may be adversely affected by storage at low temperatures. Storage at low temperatures may result in crystallisation of active constituent(s), significant changes in viscosity or phase separation of emulsions.

In some places in Australia, night temperatures regularly approach 0 ˚C or lower. Therefore, liquid formulations should also be tested at 0 ˚C ± 2 ˚C or lower for seven days. The effect of low temperatures on stability should be determined and reported according to Collaborative International Pesticide Analytical Council (CIPAC) method MT 39.3 (liquid formulations).

For capsule suspension formulations, in which the capsule walls may break as a result of repeated freezing and thawing (thus releasing the active into the suspending liquid), freeze-thaw cycling testing should also be undertaken.

Note: Stability data generated at low temperatures are not required if the product label includes a warning against exposure to low temperatures. However, the APVMA needs to be satisfied that such a restriction is practical, and suitable argument should be provided. For example, non-provision of low temperature data is more likely to be acceptable for a household insecticide spray, which would generally be stored in a kitchen or laundry and is unlikely to be exposed to freezing temperatures, than for a herbicide for use in cereals and which is likely to be stored during winter in unheated and uninsulated sheds. 

2.6. Test parameters

The stability profile of an agricultural chemical product is determined by monitoring a combination of chemical and physical properties during storage. Monitoring the content of active constituent alone is insufficient to make any reliable prediction about the stability of the product. On prolonged storage, a product may exhibit negligible decline in the concentration of active constituent, yet the important physical properties (for example, wettability or suspensibility) may have changed to such an extent that the performance of the product can be compromised.

This guideline includes relevant test parameters for each formulation type. It is expected that all relevant parameters are addressed in a stability trial, in order to adequately demonstrate product stability. If certain parameters are not addressed, then a relevant scientific argument should be provided.

Note that the relevant test parameters have mainly been derived from the FAO/WHO pesticide specifications. For formulation types not listed in this guideline, it is recommended that you seek advice from APVMA before commencing a stability trial, in the form of an enquiry, Pre-Application Assistance Application, or item 25 technical assessment, depending on the level of technical advice/assessment required.

2.7. Containers

The effect of the formulation on the primary pack and vice versa is important, and therefore the product should be packaged in the same containers (materials and pack size) that are proposed for the marketing of the final product. If the product is to be marketed only in containers in which stability testing would be impractical (for example, because they are too large), then stability trials in smaller containers of the same materials and construction may be used to extrapolate to the larger containers.

The packaging materials, size of the container, and the quantity of the product in the container used in stability trial should be provided as part of the stability trial information.

Containers should be examined after the trial storage period to ensure that no significant interaction with the formulation (affecting the stability or integrity of the packaging material) has taken place during storage.

2.8. Product in water-soluble bags

Effects on the physical characteristics of a product are known to occur when a product is packaged in water-soluble bags or sachets. Therefore, when this type of packaging is proposed, relevant physical tests should be conducted in the presence of the soluble bag material, using the same ratio of formulation and bag material as will occur in the spray tank or other application equipment.

In addition, testing of the dissolution characteristics of water-soluble bags should be carried out using CIPAC method MT 176. The dissolution time should be reported.

Leakage and/or effects of the formulation on water-soluble bags should be examined. Where multiple bags are to be packaged in a single container, evidence should be provided that the integrity of the water-soluble packaging is not affected either by the opening and resealing of the outer pack or by moisture entering through routine use. This may be achieved by storing a multi-bag pack at 25 ˚C over a six-month period and periodically removing a water-soluble bag, until all bags have been removed. The integrity of the water-soluble bags should be examined on removal. In the resulting report, the time interval between openings and the approximate duration the container was open for should be specified.

If the product is to be packaged in a water-soluble pack, the packaging material is treated as part of the formulation composition. Therefore, if the product is currently registered in some other packaging, a change to water-soluble packaging would require additional stability trials examining the product packaged in water-soluble bags.

2.9. Analytical methods and validation data

2.9.1. Determination of active constituent content and relevant impurities

Full details of the analytical methods used to monitor the product during stability trials should be provided, except where you have used collaboratively tested standard methods (CIPAC, Association of Official Analytical Chemists (AOAC), etc.) for the analysis.  Compendial methods such as CIPAC methods are regarded as validated and do not require full revalidation (for further details of the necessary degree of method validation see the separate guideline on validation of analytical methods.

The following information should be included:

  • instrumentation
  • sample preparation
  • method of extraction of the active constituent from the product
  • reference standards and reagents preparation
  • validation data
  • copies of representative chromatograms (if applicable)
  • representative calculations.

Analytical methods described in CIPAC handbooks and the AOAC manual for an agricultural active constituent and agricultural chemical product are legally recognised as the regulatory methods, and these procedures (if one is available) are used by the APVMA. The APVMA recommends that analytical methods described in official and recognised publications, such as CIPAC handbooks and AOAC, for a particular formulation be used, where available.

Alternative analytical methods may be used in place of regulatory methods. Appropriate validation data is required for such methods. The type of validation data required is dependent on the analytical technique, but typically includes demonstration of linearity over a suitable concentration range, specificity, precision and accuracy (see the separate guideline on validation of analytical methods for further information).

2.9.2. Determination of physical properties

The results and interpretation of the measurement of physicochemical properties are highly dependent on the analytical procedures used. APVMA recommends that standard CIPAC or equivalent accepted methods are used to measure the physicochemical properties of agricultural chemical products. Validation data are not required for CIPAC, or other appropriate compendial methods for physicochemical tests. If in-house company methods or other methods are used for physicochemical property testing, a full description of the procedure should be provided, together with appropriate validation data. This may include a comparison between the officially recognised method (CIPAC handbooks and the AOAC manual for an agricultural active constituent and agricultural chemical product) and the in-house method with comment on any differences and the importance of any difference.

3. Test parameters for products

The data and/or testing parameters that the APVMA adopts are derived from the FAO/WHO pesticide specifications.

3.1. Active content

For stability testing of most products, testing of the active content before and after storage using a suitable specific chemical analytical method is required.

In some specific cases, chemical analyses of the active content before and after storage may not be required. Examples include:

  • highly acidic or caustic dairy sanitisers containing nitric acid and sulfamic acid, nitric acid and phosphoric acid, or alkaline salt blends as the active generally do not require chemical testing of the active content, as the activity of the product before and after storage can be demonstrated through measurement of pH and/or total acidity/alkalinity
  • acetic acid weedkillers – again, stability of these can generally be demonstrated by measurement of pH before and after storage
  • spray adjuvants containing blends of non-ionic surfactants and paraffinic oils or canola fatty acid methyl/ethyl esters – the stability of these can generally be sufficiently demonstrated by measurement of physicochemical properties alone (appearance, emulsion stability, pH, persistent foam, and packaging stability). 

Biological products such as those containing Bacillus thuringiensis as the active should be tested using suitable methods such as a colony-forming units assay, or an insect biopotency test.

For products demonstrating good stability, significant changes in active content should not be observed in real time or accelerated stability studies. Simply remaining within the allowable variation for active content defined in the Agvet Code Regulations is not sufficient in itself, as these variations are intended to allow for batch to batch variation in the manufacturing process and in sampling, rather to account for declines on storage.

The active ingredient content should in general not decline by more than 5% with respect to the level measured initially in accelerated or real time testing. Further information and justification should be provided if the level of degradation exceeds 5%.

Measures taken to demonstrate and/or justify the quality, safety and efficacy of a formulation showing high levels of degradation on storage could include the following where appropriate:

  • identification and quantification of degradation products;
  • inclusion of a manufacturing overage not greater than 10% of the label claim to allow for degradation on storage;
  • registration of the product subject to a condition of inclusion of an expiry date shorter than the standard two years from the date of manufacture;
  • conducting efficacy studies on aged batches of product to show that acceptable levels of efficacy are retained despite the decline in active content.

3.2. Content of relevant impurities

For some active constituents, testing of levels before and after storage of toxicologically significant breakdown products, or impurities likely to accelerate formation of toxicologically significant breakdown products (e.g. water in diazinon) may be required.

Examples of toxicologically significant impurities that can form or increase in a formulated product on storage are tabulated below.

Active constituent Relevant impurities
Diazinon Water

0,0,0',0'-tetraethyl thiopyrophosphate (0,S-TEPP)

0,0,0',0'-tetraethyl dithiopyrophosphate (S,S-TEPP)
Dimethoate O,O,S-trimethyl phosphorodithioate

Omethoate

Isodimethoate

Water
Mancozeb, metiram, propineb, zineb Ethylene thiourea

These impurities must be tested using suitable methods supported by appropriate validation data. Where appropriate, compendial methods should be used. CIPAC MT30.5 is a compendial method commonly used for determination of trace levels of water in formulations.

Levels of these impurities before and after storage must be within specified limits that can be justified from a human safety perspective. For determination of suitable specified limits, good references are the APVMA active constituent standards, or the FAO pesticide specifications. You should bear in mind that impurity limits in the APVMA active constituent standard are established for the technical active, not a formulated product and appropriate conversion factors need to be applied if setting limits on the basis of g/kg or g/L in a formulation.

3.3. Appearance and physical state

These tests are performed visually and are described in qualitative terms such as solid, liquid, suspension etc.

3.3.1. Colour

The following test methods are recommended:

A visual description of colour is also acceptable.

3.3.2. Odour

This test is performed organoleptically and involves the use of descriptive terms (for example, thymol-like odour), characteristics of aromatic compounds (for example, garlic-like).

3.4. Acidity or alkalinity and pH

This test is recommended for any product where acidity or alkalinity and pH are relevant parameters for the quality of the product. Where relevant (that is, when the product is to be applied as an aqueous dilution), the pH of a one per cent aqueous dilution, emulsion or dispersion of the product should be determined and reported according to CIPAC method MT 75.3. A change in pH on storage can give an indication of instability of the active substance or product.

The acidity or alkalinity is determined by titration with standard acid or alkali according to CIPAC method MT 31.

3.5. Wettability

Wettability of solid products that are diluted for use (for example, wettable powders, water-soluble powders, water-soluble granules and water-dispersible granules) is determined to ensure the product is adequately wetted before use.

The CIPAC method for determination of wettability is: MT 53.3.

3.5.1. Acceptable limits for wettability

The wettability of a product is considered acceptable if there is complete wetting in one minute, without swirling.

If the product is outside these limits, then evidence should be submitted that demonstrates the product has acceptable dispersion in the spray tank or other application equipment.

3.6. Persistent foaming

Persistent foam is a measure of the amount of foam likely to be present in a spray tank or other application equipment following dilution of the product with water in accordance with the label instructions.

The CIPAC method for persistent foaming is: MT 47.1 or 47.2.

Although MT 47.2 was standardised for the determination of persistent foam in suspension concentrates, it is also applicable to other products that are dispersed in water.

3.6.1. Acceptable limits for persistent foaming

The following acceptable limits apply:

  • MT 47.1—max 25 mL foam after 1 min
  • MT 47.2—max 60 mL foam after 1 min.

Where levels of persistent foam exceed these limits, further data or scientific argument will be required to demonstrate that the product can be mixed and applied without unacceptable risk to the environment or the operator as a result of spillages or contact from excessive foam escaping from the tank. This could take the form of a field scale test of mixing the product in commercial spraying equipment to demonstrate that foam levels are acceptable in practice.

3.7. Suspensibility

Suspensibility of water-dispersible products (for example, wettable powders, water-dispersible granules and suspension concentrates) is determined to demonstrate that a sufficient amount of the active substance is suspended in the spray liquid to give a satisfactory, homogeneous mixture during spraying.

The following CIPAC methods apply:

  • MT 15.1—wettable powders
  • MT 161—aqueous suspension concentrates
  • MT 168—water-dispersible granules
  • MT 177—water-dispersible powders
  • MT 184—formulations forming suspensions on dilution with water.

For the determination of suspensibility, chemical assay (active suspensibility) is the only fully reliable method to measure the mass of the active substance still in suspension. However, gravimetric determination (total suspensibility) or solvent extraction determination may be used on a routine basis, provided that these methods have been shown to give equivalent results to those of the chemical assay.

When the solvent extraction method is used, the product should be assayed using the same technique to allow comparison of the results.

Where there is more than one insoluble active substance present in the product, chemical assay (active suspensibility) is the only acceptable method.

The suspensibility test should be performed at the highest and lowest dilutions recommended on the product label.

3.7.1. Acceptable limits for suspensibility

  • The mean measured active suspensibility should not be less than 60 per cent and not greater than 105 per cent.

If a product is outside these limits, evidence should be provided to demonstrate that the product is homogeneous on application through appropriate application equipment (for example, through determination of active content in the spray at the beginning, middle and end of the spraying operation).

3.8. Spontaneity of dispersion (suspension stability)

The spontaneity of dispersion of water-dispersible products (for example, water-dispersible granules and suspension concentrates) is determined to show the product is easily and rapidly dispersed when diluted with water.

The following CIPAC methods apply:

  • MT 160—suspension concentrates
  • MT 174—water-dispersible granules.

Chemical assay is the only reliable means to measure the mass of the active substance in suspension. However, gravimetric determination or solvent extraction determination may be used on a routine basis, provided you it can be shown that these methods give equivalent results to those of the chemical assay.

When using the solvent extraction method, the product should be assayed using the same technique, to allow comparison of the results.

Where there is more than one insoluble active substance present in the product, chemical assay is the only acceptable method.

3.8.1. Acceptable limits

  • The mean measured active suspensibility or dispersibility should not be less than 60 per cent and not greater than 105 per cent.

Where a product is outside these limits, evidence should be provided to demonstrate that the product is homogeneous on application through appropriate application equipment.

3.9. Dilution stability

Dilution stability is determined to ensure water-soluble products dissolve readily and, when diluted, produce stable solutions without precipitation, flocculation, etc.

The following CIPAC methods apply:

  • MT 179—degree of dissolution and solution stability
  • MT 41—dilution stability of herbicide aqueous solutions.

3.9.1. Acceptable limits for dilution stability

  • MT 41—‘trace’ of sediment after 30 minutes
  • MT 179—max 2 per cent on 75 μm sieve.

Where a product is outside these limits, evidence should be provided that shows the material separated will not block nozzles in application equipment.

3.10. Dry sieve test

The dry sieve test is designed to determine the particle size distribution of dustable powders and granules that are intended for direct application, to ensure acceptable application.

The following CIPAC methods apply:

  • MT 59.1 dusts
  • MT 59.2 granular formulations
  • MT 170 water-dispersible granules.

3.10.1. Acceptable limits for the dry sieve test

Maximum 5 per cent is retained on a 75 µm sieve (dustable powders) not more than (0.005 times the active content in grams per kilogram [g/kg]) per cent should be present as the active in the residues on the sieve.

For dustable powders, if 5 per cent or more of the product is retained on a 75 micrometre (μm) sieve, the active content of material remaining on the sieve should be determined to demonstrate there was no separation of the active substance from the carrier.

3.11. Wet sieve test

For water-dispersible products, a 75 micrometre (μm) wet sieve test should be conducted. Wet sieve analysis determines the quantity of particles in a formulation collected on a screen after dilution in water.

The following CIPAC method applies:

  • MT 185—wet sieve test, a revision of methods MT 59.3 and MT 167.

The residue remaining on a sieve is determined after dispersion to ensure that no unacceptable residue remains, which can cause blockage of nozzles in application equipment.

This test is applicable to wettable powders, suspension concentrates, water-dispersible granules, aqueous capsule suspensions, dispersible concentrates, suspo-emulsions, water-soluble granules and water-soluble powders.

3.11.1. Acceptable limits for the wet sieve test

  • Maximum 2 per cent retained on a 75 µm sieve.

Where a product is outside these limits, evidence should be provided that shows the product may be satisfactorily applied through appropriate application equipment with no blockage.

3.12. Particle size distribution

You should determine the nominal size range for solid materials for direct application (for example, dustable powders and granules) and solid materials for dispersion in water (for example, wettable powder and granules). The data are used to assess if an acceptable proportion of the product is within an appropriate size range.

The following methods apply:

  • CIPAC MT 170—water-dispersible granules
  • CIPAC MT 187—particle size analysis by laser diffraction
  • OECD method 110—powders or dusts.

3.13. Dust content

The dust content of solid preparations should be determine to ensure the risk to operators when transferring the product from the primary pack into the mixing tank is acceptable and to determine the potential for blockage of application equipment.

The following methods apply:

  • CIPAC method MT 171—granular products
  • OECD method 110—powders or dusts.

MT 171 describes two methods for the determination of dustiness, but the gravimetric method is regarded as the reference method.

3.13.1. Acceptable limits for dust content

If 1 per cent, by weight, of the preparation has a particle size of less than 50 µm, you should provide inhalation toxicity data.

3.14. Emulsifiability, re-emulsifiability and emulsion stability

For products that form emulsions, data on emulsifiability, emulsion stability and re-emulsifiability are used to determine whether a product forms and maintains a stable emulsion.

The following CIPAC methods apply:

  • MT 36.1—5 per cent dilution
  • MT 36.2—1 per cent dilution
  • MT 36.3—emulsion characteristics and re-emulsification properties
  • MT 173—0.1–2 per cent dilution.

MT 36.1 is designed to be conducted over a 24-hour period. If no separation of cream or oil is observed after two hours, then no further testing is required. However, if separation is observed, you should perform the 24-hour test.

For dilute emulsion, MT 173 is the preferred method. However, MT 36.1 may be used as a screening method. If no separation of the 5 per cent dilution is seen after two hours, then no further testing is required. The test should be conducted in CIPAC waters A and D.

3.14.1. Acceptable limits for emulsifiability, re-emulsifiability and emulsion stability

  • MT 36.1—maximum 2 mL cream, trace of oil after 30 minutes; if any separation is observed, re-emulsification should be complete after 24 hours
  • MT 173—min 98 per cent after 4 hours; max 102 per cent after 4 hours.

If a product is outside these limits, evidence should be provided that shows the product remains homogeneous when applied through appropriate application equipment. If more than a trace of oil separates, re-formulation of the product should be considered.

3.15. Dispersion stability of suspo-emulsions

Data should be provided to ensure that a sufficient amount of active constituent is homogeneously dispersed in suspension and emulsion in the spray liquid, to give a satisfactory and effective mixture during spraying.

The following CIPAC method applies: MT 180.

3.15.1. Acceptable limits for stability of suspo-emulsions

  • Maximum 2 mL cream, trace of oil after 30 min. If any separation is observed, re-emulsification should be complete after 24 hours.

If a product is outside these limits, evidence should be provided that shows the product remains homogeneous when applied through appropriate application equipment. If more than a trace of oil separates, re-formulation of the product should be considered.

3.16. Pourability (rinsibility) of suspension concentrates

Data are required to demonstrate that the user can make use of the maximum amount of the product in the container and that an excessive amount of the material does not remain in the container. This test should be conducted with suspension concentrates, capsule suspensions and suspo-emulsions.

The following CIPAC methods apply:

  • MT 148
  • MT 148.1 (revised method).

3.16.1. Acceptable limits for pourability (rinsibility) of suspension concentrates

Maximum 5 per cent residue; maximum 0.25 per cent rinsed residue.

If a product is outside these limits, evidence should be provided on the level of residue remaining in the commercial pack following recommended rinsing procedures.

3.17. Attrition and friability

Attrition is defined as the wearing away of the surface of a granule by friction or impact, particularly by granule-to-granule interaction.

Friability is defined as the tendency of the granule to crumble, breaking down to smaller particles.

Data are required to determine whether a granular material is robust under normal conditions of use and transport.

The following CIPAC methods apply:

  • MT 178—measures attrition resistance of granules
  • MT 178.2—measures attrition resistance of dispersible granules.

3.17.1. Acceptable limits for attrition and friability

If the material has an attrition resistance of less than 98 per cent, evidence is required that the material may be satisfactorily applied through application equipment.

3.18. Viscosity

The viscosity of a fluid is the property that determines the resistance offered to a shearing force under laminar flow conditions; for example, resistance to slow stirring, or to flow through a capillary or narrow channel.

The kinematic viscosity of liquid formulation for direct application (ultra-low-volume products) should be determined. For Newtonian fluid, the viscosity at any shear rate should be conducted; whereas, if the product is a non-Newtonian fluid (for example, a non-drip paint), viscosity values should be provided for at least two different shear rates.

The following CIPAC methods apply:

  • MT 22
  • MT 114.

3.19. Flowability

The following methods apply:

  • CIPAC method MT 44
  • OECD method MT 172.

3.19.1. Acceptable limits for flowability

The sample should flow through the sieve after a maximum of five liftings.

3.20. Dissolution rate of water-soluble bags

The dissolution rate of water-soluble bags should be carried out to demonstrate that particles of water-soluble material will not block nozzles of application equipment.

The following CIPAC method applies:

  • MT 176.

3.20.1. Acceptable limits for the dissolution rate of water-soluble bags

The dissolution rate of water-soluble bags is 30 seconds.

3.21. Disintegration time and degree of dispersion or dissolution

Data are required to demonstrate that soluble or dispersible tablets disintegrate rapidly on addition to water and that the formulation is readily dispersed or dissolved.

4. Parameters to be tested in stability trials

In addition to appearance and content of active constituent, the relevant physical chemical properties of each formulation type should be monitored before and after storage where applicable. For the following shelf-life specifications, the physical properties mentioned in the FAO/WHO pesticide specifications have been selected as they are applicable to the given formulation type. The APVMA will update the relevant test parameters for the additional formulation types listed in the Formulation Types guideline.

International codes used below are based on the Catalogue of pesticide formulation types and international coding system (CropLife International 2008). Individual CIPAC MT test parameters are listed with each individual formulation type within this document.

In this guideline CIPAC MT methods are referenced as the appropriate MT number (for example, MT 59.1 = CIPAC MT 59.1).

Table 2: Dustable powders (DP)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Dry sieve test MT 59.1
Packaging stability Observation of packaging stability
(Note: There should be no caking in the pack on storage.)
Table 3: Powders for dry seed treatment (DS)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Dry sieve test MT 59.1
Particle size distribution OECD 110
Adhesion to seeds Appropriate validated method
Packaging stability Observation of packaging stability
Table 4: Granules (GR)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Pour and bulk density MT 186
Particle size distribution MT 58.3
Dust content MT 171
Friability and attrition characteristics MT 178
Release rate of active constituent Suitable validated method
Packaging stability Observation of packaging stability (Note: There should be no loss of granule integrity or caking on storage.)
Table 5: Tablets for direct application (DT)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Tablet integrity Visual observation
(Note: No broken tablets.)
Tablet hardness No CIPAC method
Degree of attrition MT 193
Packaging stability Observation of packaging stability
Table 6: Wettable powders (WP)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Wet sieve test* MT 185
Suspensibility* MT 184
Wettability* MT 53.3
Persistent foam* MT 47.2
Dissolution of water-soluble bags MT 176
(Note: Only if the product is packaged in a sealed water-soluble bag.)
Packaging stability Observation of packaging stability (Note: There should be no caking in the pack on storage.)

* If the product is packaged in a water-soluble bag, the wet sieve test, suspensibility, wettability test and persistent foam test should be performed using a solution of the product and water-soluble bag in the same ratio as in the recommended application.

Table 7: Water-dispersible powders for slurry seed treatments (WS)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Wet sieve test MT 185
Wettability MT 53.3
Persistent foam MT 47.2
Dissolution of water-soluble bags MT 176
(Note: Only if the product is packaged in a sealed water-soluble bag.)
Packaging stability Observation of packaging stability
Table 8: Water-dispersible granules (WG)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Wet sieve test* MT 185
Degree of dispersion MT 174
Suspensibility* MT 184
Wettability* MT 53.3
Persistent foam* MT 47.2
Dust content MT 171
Flowability MT 172
Attrition resistance MT 178.2
Packaging stability Observation of packaging stability
(Note: There should be no caking in the pack on storage.)

* If the product is packaged in a water-soluble bag, the wet sieve test, suspensibility, wettability test and persistent foam test should be performed using a solution of the product and water-soluble bag in the same ratio as in the recommended application.

Table 9: Water-dispersible tablets (WT)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Tablet integrity Visual observation
(Note: No broken tablets.)
Suspensibility MT 184
Disintegration time Appropriate method
Wet sieve test MT 185
Persistent foam MT 47.2
Packaging stability Observation of packaging stability
Table 10: Emulsifiable granules (EG)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Wettability MT 53.3
Dispersion stability MT 180
Wet sieve test MT 185
Dustiness MT 171
Persistent foam MT 47.2
Packaging stability Observation of packaging stability

* If the product is packaged in a water-soluble bag, the wet sieve test, suspensibility, wettability test and persistent foam test should be performed using a solution of the product and water-soluble bag in the same ratio as in the recommended application.

Table 11: Emulsifiable powders (EP)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Wettability MT 53.3
Dispersion stability MT 180
Wet sieve test MT 185
Persistent foam MT 47.2
Packaging stability Observation of packaging stability

* If the product is packaged in a water-soluble bag, the wet sieve test, suspensibility, wettability test and persistent foam test should be performed using a solution of the product and water-soluble bag in the same ratio as in the recommended application.

Table 12: Water-soluble powders (SP)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Persistent foam* MT 47.2
Wettability* MT 53.3
Degree of dissolution and solution stability* MT 179
Dissolution of water-soluble bags MT 176
(Note: Only required if the product is packaged in a sealed water-soluble bag.)
Packaging stability Observation of packaging stability
(Note: There should be no caking in the pack on storage.)

* If the product is packaged in a water-soluble bag, the wet sieve test, suspensibility, wettability test and persistent foam test should be performed using a solution of the product and water-soluble bag in the same ratio as in the recommended application.

Table 13: Water-soluble powders for seed treatment (SS)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Degree of dissolution and solution stability MT 179
Packaging stability Observation of packaging stability
(Note: There should be no caking in the pack on storage.)
Table 14: Water Soluble Granules (SG)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Dust content MT 171
Degree of dissolution and solution stability* MT 179
Persistent foam* MT 47.3
Attrition resistance MT 178.2
Flowability MT 172.1
Dissolution of water soluble bags Comment: Only for the product packaged in a sealed water soluble bag.
Packaging stability Observation of packaging stability

*Where the product is packaged in a water soluble bag then the persistent foam, and degree of dissolution and solution stability tests must be carried out using a solution of the product and water soluble bag in the same ratio as in the recommended applications.

Table 15: Water-soluble tablets (ST)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)

Tablet integrity

Visual observation
(Note: No broken tablets.)
Degree of dissolution and solution stability MT 179
Wet sieve test MT 185
Disintegration time Appropriate method
Persistent foam MT 47.2
Degree of attrition MT 193
Packaging stability Observation of packaging stability
Table 16: Soluble concentrates (SL)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Solution stability MT 41
Persistent foam MT 47.2
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 17: Ready to use liquid formulations (AL)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 18: Solutions for seed treatment (LS)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Solution stability MT 41
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 19: Oil miscible liquids (OL)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity/alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Miscibility with hydrocarbon oil MT 23
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 20: Ultra low volume liquids (UL)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Low temperature stability MT 39.3
Kinematic viscosity MT 22, OECD 114
Packaging stability Observation of packaging stability
Table 21: Emulsifiable concentrates (EC)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Emulsion characteristics MT 36.1, MT 36.2, MT 36.3, MT 173 or MT 183
Persistent foam MT 47.2
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 22: Dispersible concentrates (DC)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour)

 

No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Dispersion stability MT 180
Wet sieve test MT 185
Persistent foam MT 47.2
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 23: Emulsions, oil in water (EW)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Emulsion characteristics MT 36.1, MT 36.2, MT 36.3, MT 173 or MT 183
Pourability MT 148.1
Persistent foam MT 47.2
Viscosity MT 192
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 24: Emulsions for seed treatment (ES)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Emulsion stability on dilution with water Appropriate method
Persistent foam MT 47.2
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 25: Micro-emulsions (ME)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Emulsion characteristics MT 36.1, MT 36.2, MT 36.3, MT 173
Persistent foam MT 47.2
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 26: Suspo-emulsions (SE)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Dispersion stability MT 180
Pourability MT 148.1
Wet sieve test MT 185
Persistent foam MT 47.2
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 27: Suspension concentrates (SC)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Pourability MT 148
Suspensibility MT 184
Spontaneity of dispersion MT 160
Wet sieve test MT 185
Persistent foam MT 47.2
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 28: Suspension concentrates for seed treatment (FS)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Pourability MT 148
Suspensibility MT 184
Wet sieve test MT 185
Persistent foam MT 47.2
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 29: Capsule suspensions (CS)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Pourability MT 148
Suspensibility MT 184
Spontaneity of dispersion MT 160
Wet sieve test MT 185
Persistent foam MT 47.2
Low temperature stability MT 39.3
Freeze - thaw stability No CIPAC method (Note: Testing of stability parameters [acidity, alkalinity or pH range; pourability; suspensibility; spontaneity of dispersion; wet sieve test] required after freeze - thaw cycle)
Packaging stability Observation of packaging stability
Table 30: Oil-based suspension concentrates (OD)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Acidity or alkalinity or pH MT 31 or MT 191 or pH range (MT 75.3)
Pourability MT 148
Dispersion stability MT 180
Wet sieve test MT 185
Persistent foam MT 47.2
Low temperature stability MT 39.3
Packaging stability Observation of packaging stability
Table 31: Water-soluble gels (GW)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Dilution stability* MT 41
Packaging stability Observation of packaging stability

* Only required if the preparation is to be dissolved in water.

Table 32: Mosquito coils (MC)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Average weight of coils No CIPAC method
Burning time No CIPAC method
Strength of coil No CIPAC method
Packaging stability Observation of packaging stability
Table 33: Vaporiser mats (MV)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Packaging stability Observation of packaging stability
Table 34: Liquid vaporisers (LV)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Packaging stability Observation of packaging stability (Note: No corrosion.)
Table 35: Baits (including grain bait [AB], block bait [BB], granular bait [GB], ready-to-use bait [RB] and plate bait [PB])
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method Evidence of retention of biological efficacy may be acceptable
Packaging stability Observation of packaging stability and integrity
Table 36: Products to be applied as smokes (including smoke tins [FD], smoke candles [FK], smoke cartridge [FP], smoke rodlet [FR], smoke tablet [FT], smoke generators [FU] and smoke pellets [FW])
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Burning time No CIPAC method
Evidence of combustibility No CIPAC method
Packaging stability No CIPAC method
Table 37: Aerosol dispensers (AE)
Recommended test parameters Relevant CIPAC method
Appearance (physical state, colour, odour) No CIPAC method
Active constituent content Appropriate validated method
Internal pressure No CIPAC method
Discharge rate No CIPAC method
pH No CIPAC method
Clogging of aerosol dispenser valves No CIPAC method
Spray pattern No CIPAC method
Packaging stability Observation of packaging stability (Note: No corrosion.)

5. References

Association of Official Analytical Chemists, Official methods of analysis of AOAC International, AOAC International, Arlington VA, United States.

ASTM International Annual book of ASTM standards; American Society for Testing and Materials, Philadelphia PA, United States. http://www.astm.org/BOOKSTORE/BOS/index.html (link is external)

CIPAC, CIPAC Handbooks, Black Bear Press, Cambridge, United Kingdom.

CropLife International 2008, Catalogue of pesticide formulation types and international coding system. Technical Monograph No. 2, 5th Edition, CropLife International, Brussels, Belgium.

JMPS 2010, Manual on the development and use of FAO and WHO specifications for pesticides, third revision of first edition, FAO/WHO Joint Meeting on Pesticide Specifications, the Food and Agriculture Organization and World Health Organization of the United Nations, Rome.

OECD, Guidance Document for Storage Stability Testing of Plant Protection and Biocidal Products, Series on Testing and Assessment No. 223, Series on Biocides No. 10, Organisation for Economic Cooperation and Development, Paris, France.

 

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