ACTIVE INGREDIENT (TECHNICAL GRADE)
1. DESIGNATION/IDENTITY OF a.i. Specify accordingly.
1.1 Common name (ISO)
1.2 Manufacturer or Development code
1.3 Source, Name and Address of
manufacturer and address and location of
1.5 Methods of manufacture(synthesis
1.5 Chemical name (IUPAC)
1.6 Chemical group
1.7 Structural formula
1.8 Empirical formula
1.9 Patent status
Is the a.i. under patent?
Who is patent holder
1.10 Molecular mass
1.11 CAS Number
2. PHYSICAL AND CHEMICAL PROPERTIES
(active ingredient – technical grade)
2.1 Physical state Where relevant indicate method/test used.
2.4 Density at 20oC
2.5 Vapour pressure at 20/25oC
2.7 Hydrolysis DT50 ….. Days …… 0C pH Give the DT50 of the active ingredient, with mention of temperature and pH parameters employed during the determination.
2.8 Photolysis Give the DT50 of the active ingredient (in days).
2.9 Solubility in water ……….0C ….. pH Where relevant indicate method/test used.
2.10 Solubility in organic solvents
2.11 n-octanol/water partition coefficient
2.12 Boiling point 0C
2.13 Melting point 0C
2.14 Decomposition temperature 0C
2.15 Method of Analysis and Impurities
2.16 Stability in water, hydrolysis rate,
effect of light, identity of breakdown
2.17 Stability in organic solvents used in
2.18 Stability in air; effect of light, identityof
2.19 Thermal stabilty, identity of
breakdown product. Where relevant indicate method/test used.
2.21 Flash point
2.22 Explosive properties
2.23 Oxidizing properties
2.24 Absorption spectra – UV/Visible,
infra-red, IMR, MS
2.25 Reactivity towards container material
(Active Ingredient – technical grade)
Include a copy of an executive summary discussing ALL ISSUES named under section 3 of List I or provide copies of the individual summaries from each study relating to issues mentioned under section 3. Information on the methods of testing must be provided.
ADI Acceptable Daily Intake in mg product / kg body weight.
NOEL Non observable effect level (expressed in mg product / kg weight on animal)
Short term toxicity
Oral cumulative toxicity (28 days study) Not mandatory, but can be useful.
Sub-chronic toxicity test of 90-day duration. Oral route on two species – one rodent(rat) and one non-rodent.
Dermal route – 28-days dermal, 90-days dermal. Specify accordingly.
Inhalation route 28-days inhalation, 90-days inhalation. Specify accordingly.
3.1 Eye irritation (rabbit)
3.2 Skin sensitisation (guinea pig)
3.3 Reproduction (specify species)
3.4 Subchronic toxicity 90 day NOEL
3.5 Chronic toxicity NOEL mg./kg/day
3.6 Carcinogenicity (life time) NOEL
3.7 Neurotoxicity NOEL mg/kg/day
3.8 Teratogenicity NOEL mg/kg/day
3.9 Mutagenicity /Genotoxicity
3.10 Metabolism (rat)
3.11 Other studies Provide further information relevant to the toxicity profile of the product e.g. Toxicity of major metabolites, reaction or breakdown products of the pest control products formed in/or on treated plant/crop etc, which are likely to be consumed – in cases where different from those identified in animal studies. Toxic effects on livestock, poultry, pests etc. should be given.
Provide either an executive summary or individual summaries of studies on the behaviour of the pest control product in the environment. Provide information requested for in the application form.
4.1 Birds (2 species) LD50 mg/kg Provide details of at least one land and one water bird, LD50 in mg product/kg bird weight and the NOEL. Furthermore provide information on the effect on reproduction.
4.2 Fish (2 species) LD50 mg/kg Provide details on at least two species studied, LC50 (in mg of product / litre of water) and the NOEL. Furthermore provide information on the effect on reproduction. Indicate the bioconcentration factor (BCF) on the active ingredient in tissues.
4.3 Daphnia LC50 mg/l
Specify and provide details on other organisms according to the information requested on the form.
4.4 Algae LC50 mg/l
4.5 Bees LD50 g/bee
4.6 Earthworms LC50 mg/kg
4.7 Soil micro-organisms
5. BEHAVIOUR IN ENVIRONMENT
(active ingredient – technical grade)
Provide an executive summary or copies of summaries from each study relating to the issues highlighted in the application form.
5.1 Behaviour, ways of degradation,
degradation products in soil: Indicate the degradation path of the active ingredient in the soil and the degradation products formed.
5.11 Major metabolites Specify the major metabolites in the soil and their behaviour.
5.12 DT50 (days) Specify the half-life of the active ingredient in various types of soils.
5.13 Mobility of the a.i. Specify the degree of mobility of the active ingredient in the soil hence leaching potential and possibility for ground water contamination. If high, provide details on further studies i.e. lysimeter study.
5.14 Adsorption Indicate the degree of adsorption of the active ingredient in the soil.
5.15 Mobility of metabolites Indicate the degree of mobility of the metabolites in the soil.
5.2 Behaviour, ways of degradation,
degradation products in water: Describe ways and speed of degradation of the active ingredient in water.
5.21 Major Metabolites Specify the major break down products formed and their adsorption/desorption on sediments.
5.22 DT50 (days) Specify the half-life of the active ingredient in water
5.23. Surface Describe ways and speed of degradation in surface and ground water.
5.24 Ground Provide an executive summary or copies of summaries from each study relating to the issues highlighted in the form.
5.3 Behaviour, ways of degradation,
degradation products in air: Describe ways and speed of degradation in air and break down products formed. (for fumigants and volatile products).
Provide either an executive summary or individual summaries of studies conducted concerning the issues listed in the application form.
7.1 Major metabolites Provide either an executive summary or individual summaries of studies conducted concerning the metabolites in plants.
. Specify the metabolites
. State their toxicological effects.
7.2 Metabolism Describe the principle of metabolization of the active ingredient in the plant and the degradation products formed.
7.3 Behaviour of residues Indicate the action and the persistence of the metabolites in the plant and animals.
7.4 Crop Provide either an executive summary or individual summaries of studies conducted by a GLP certified laboratory or as directed by Secretary, PCPB.
7.5 MRL codex MRL’s (if available)
When available state for each crop or vegetable product, the Maximum residue Limit (MRL) recommended by the Codex Alimentarius Commission, two effective MRL’s in two different countries and the MRL proposed in the country of application. If the proposed crop is to be exported provide detailed information in the dossier on MRL or import tolerances in the countries exported to.
7.6 MRL of country of origin
7.7 Proposed MRL
7.8 Proposed PHI
7.9 Method of residue
analysis Provide a copy in the dossier for countries requiring it.
8. OTHER SPECIFIC REQUIREMENTS
8.1 Residue data from a GLP certified
lab or as directed by Secretary, PCPB. Provide an executive summary or copies of summaries from each study relating to residues.
8.2 Proposed pre-harvest intervals,
withholding periods in cases on
8.3 Effects on taint, odour, taste or other
quality aspects due to residues in or
on fresh or processed products.
8.4 Effects of industrial processing
and/or household preparation on the
nature and magnitude of residues.
8.5 Residue data in succeeding
rotational crops where presence of
residues might be expected.
GUIDELINE: FORMULATED PRODUCT DOSSIER
1. PHYSICAL AND CHEMICAL PROPERTIES OF THE FORMULATED
Clearly state methods used to determine properties under the appropriate section of the dossier. CIPAC methods are recommended.
1.1 Physical state / formulation type Solid, liquid etc.
1.4 Storage stability Indicate the stability of the preparation after storing at 54oC for 14 days. Other durations and/or other temperatures (e.g. 8 weeks at 40oC, 18 weeks at 30oC) if the preparation is thermo-sensitive.
1.5 Shelf-life The shelf-life of the product at room temperatures (30oC) is given in years if it is more than two years, and in months if it is less than two years. The appropriate temperature specifications must be given.
1.6 Density Indicate the density of the liquids.
1.7 Bulk density Indicate the density of solids after compression.
1.8 Flammability Specify if the product is flammable
1.9 Flash point To determine flammable hazards.
1.10 Compatibility with other pest control
products Indicate types of pest control products which the product is or is not compatible with. Give evidence.
1.11 pH range State the effect of pH on stability and effectiveness.
1.12 pH of 1% aqueous dilution Relevant to products to be diluted in water.
1.13 Oxidizing properties Indicate materials that can be damaged by oxidizing properties of the formulation.
1.14 Corrosiveness Specify effect on containers, equipment, skin etc.
1.15 Water content Indicate the maximum water content when it has an influence on the quality.
1.16 Wettability The wettability has to be indicated for solid formulations used in dilution (wettable powders, powder soluble in water and granules soluble in water).
1.17 Solubility in water Specify
1.18 Persistent foaming State the extent to which foaming occurs for formulations diluted in water.
1.19 Particle size Specify
1.20 Wet sieve test
1.21 Dry sieve test
1.22 Suspensibility / emulsifiability Specify
1.23 Emulsion stability
1.25 Viscosity For formulations to be used at very low volume, it is necessary to know the viscosity.
1.26 Other properties (where applicable) FAO specifications etc.
1.27 Method of Analysis
The dossier must contain a detailed Material Safety Data Sheet(MSDS). Furthermore an executive summary discussing all aspects mentioned under section 2 must be included, or the summaries from each individual toxicity study under 2.1-2.6.
Provide detailed studies and any other relevant toxicology or ecotoxicological studies conducted on the formulated product.
The FAO/WHO class must be given as per the table hereunder.
Class LD50 for the rat (mg/kg body weight)
Solids Liquids Solids Liquids
Hazardous 5 or less 20 or less 10 or less 40 or less
Ib Highly Hazardous 5-50 20-200 10-100 40-400
II Moderately Hazardous 50-500 200-2000 100-1000 400-4000
III Slightly Hazardous Over 500 Over 2000 Over 1000 Over 4000
3. EMERGENCY MEASURES IN CASES OF ACCIDENTAL EXPOSURE OR
Self explanatory. List relevant information of the form and refer to relevant section in MSDS in section 3 of dossier.
4. EMERGENCY PROCEDURES IN CASE OF FIRE/SPILLAGE
Self explanatory. List relevant information of form and refer to relevant section in MSDS in section 2 of dossier.
5. EFFICACY DATA
5.1 Crop/area of use The common name of the crop on which the product is aimed at must be clearly specified.
When the product is not aimed at a crop, indicate the area of use, e.g.
. Premises and equipment of transportation,
. Premises of storage.
5.2. Target organism Target organisms must be identified by common and scientific name.
Specify the mode of action of the product on its target, and indicate if the active ingredient is translocated inside the organisms.
5.3 Rate The rate of application must be indicated on the basis of area treated or volume used e.g. l/ha, g/ha, etc.
5.4. Stage of treatment Specify the stage of the crop or target organism at which application must be made and/or the minimum interval between the last application and harvest.
5.5 Directions for use Indicate the recommended directions for use.
5.6 Residue data and pre-harvest interval Indicate restrictions.
5.7 Phytotoxicity Indicate restrictions.
5.8 Contraindications Indicate restrictions i.e. follow up crops, adjacent crops etc. and particular specifications, as well as possible incompatibilities of the formulation with other products.
NB: Efficacy data from country of origin should be attached.
6. MINIMUM LABEL REQUIREMENTS
Specify the warnings, use restrictions and safety precautions which must be present on the label in all countries.
The proposed label must be included in the dossier and should contain the specified warnings, use restrictions and safety precautions as well as meet PCPB label requirements, recommendations etc.
The PCPB label requirements will be provided separately.