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Definitions of the properties given on the fact sheets

This guide defines the properties listed in the six sections on each active substance fact sheet.

Version of 23 November 2012

1 - IDENTITY OF THE SUBSTANCE
  • The denominations correspond to a list of names: common name, acronyms, synonyms, name proposed by the manufacturer and the ISO standardisation body, Chemical Abstracts Service (CAS) registration number, EEC registration number, CIPAC code number.

  • The chemical class and isomeric composition of the active substance are specified.

  • The biological activity is specified (e.g. herbicide, fungicide, etc.).


1.1 DEVELOPED CHEMICAL NAMES

  • ACCORDING TO THE CA STANDARD

    The query table of the Chemical Abstracts (CA) base first describes the active substance's main backbone, then the substituents and finally any information on its stereochemistry. For example: aminopropyl phosphonic acid (+ -) is queried as PHOSPHONIC ACID, (1-AMINOPROPYL)-, (+-).

  • ACCORDING TO THE IUPAC STANDARD

    They are described according to the latest rules of the International Union of Pure and Applied Chemistry (IUPAC).

1.2 EMPIRICAL FORMULA

The active substances are first described as carbohydrates: C, H, then the substituents are counted in alphabetical order: Cl, F, N, O.

1.3 REGULATED IMPURITIES

If the substance contains toxic impurities whose levels are regulated, these are named and their maximum permissible limits are given.

============================================

The tests listed below must follow the guidelines of the OECD, EC or other recognised methods, when available, and should be conducted according to good laboratory practice.

OECD website : http://www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/oecdguidelinesforthetestingofchemicals.htm

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2- PHYSICAL AND CHEMICAL PROPERTIES 

2.1 PHYSICAL STATE

The active substance may be a solid (powder, granules), a liquid or a gas whose colour and odour may be specified.

2.2 VAPOUR PRESSURE

Vapour pressure characterises the ability of an active substance to volatilise. It is expressed in Pascals (Pa), formerly in millimeters of mercury (101325 Pa = 1 atmosphere = 760 mm Hg).
The temperature is expressed in degrees Celsius.


2.3 HENRY'S LAW

Henry's Law characterises the ability of an active substance in solution to volatilise. It is expressed in Pascals / m³ / mol.
The temperature accompanies this data.


2.4, 2.5 SOLUBILITY IN WATER or IN ORGANIC SOLVENTS

Solubility is expressed :

- by a numeric value (in g/L or mg/L) using the most appropriate unit.
- or by a qualitative approximation chosen from a hierarchical range (from insoluble to miscible).

2.6 OCTANOL/WATER PARTITION COEFFICIENT

  • P is the octanol/water partition coefficient. It is a dimensionless ratio, defined at a given temperature and pH. It is also known as Kow. It is often expressed in logarithm form.
  • log P is an indicator of a substance's lipid solubility. If log P >= 3, the active substance is liable to bioaccumulate.


2.7 HYDROLYSIS RATE

This is assessed by the time taken for 50% of the active substance to degrade in water (DT50), and is expressed in days or hours at a given pH and determined by a laboratory test.


2.8 PHOTOLYSIS RATE

This is assessed by the time taken for 50% of the active substance to degrade in water under the influence of light (DT50), and is expressed in days or hours at a given pH and determined by a laboratory test.

The nature of the light source is specified (natural or xenon lamp), as well as the duration and intensity of the light. If it is natural light, the place and season is mentioned.


2.9 DISSOCIATION IN WATER

PKa is the dissociation constant; it defines the strength of an acid. It specifies the pH at which there is a change in the ionisation state of the molecule. It is a unitless property, generally determined at 20°C, otherwise the temperature is given.

PKb is defined by the relationship pKa + pKb = 14.

Some molecules are not dissociated in water, in this case "no dissociation" is indicated.

3 - TOXICITY

3.1 ABSORPTION, DISTRIBUTION AND METABOLISM (ADME)

The nature and intensity of an active substance's toxic effects on an organism depend on its concentration in the target organs. This concentration is related to the dose administered and also to the substance's fate in the organism (i.e. absorption, distribution, metabolism and excretion). The animal species of choice is the rat.

Oral absorption

This is the process by which a substance enters the body after oral administration.

A rate of oral absorption is estimated for each substance, in a specific time interval.

Distribution and bioaccumulation potential

After absorption, substances are distributed by the blood throughout the body, including the excretory organs where they are eliminated. The substance's distribution in the different areas of the body can be characterised as uniform, or otherwise localised in certain tissues (e.g. adipose tissue).

Animal metabolism

This is the generally enzymatic process by which a foreign substance is transformed into more polar (i.e. more water soluble) derivatives, which are more easily excreted and generally less toxic. The liver, the organ with the greatest number of enzymes and blood vessels, is the primary site of metabolism.

Excretion

Urine and faeces are the main routes of excretion for the active substances and their metabolites. The faster the excretion, the less concentrated the substance and its metabolites become, and the less time it has to exert its toxicity.

The rate of excretion according to a given time interval and the relative share taken by urinary or faecal excretion are specified.


3.2 DERMAL ABSORPTION

This is the process by which a substance passes through the body from the area of penetration (the skin) to the organs and tissues.

Dermal exposure is the main route of contamination for workers handling agricultural products.

The physico-chemical properties enable the dermal absorption of the substance to be estimated. Based on these properties, French and European experts can select a default value.

To refine the estimate, experimental studies need to be conducted, in vitro using human or rat skin and in vivo using rats. These studies enable a quantitative determination of absorption.

A dermal absorption percentage is calculated; this is the ratio between the absorbed dose and the applied dose

3.3, 3.4 ACUTE TOXICITY BY ORAL OR DERMAL ROUTE

For a given species, the LD50 is the Dose of an active substance that is Lethal (deadly) for 50 percent of a batch of laboratory animals subjected to testing after a single administration of the active substance.

The preferred animal species is the rat.

The LD50 is expressed in milligrams of active substance per kilogram of body weight of the animal tested..


3.5 ACUTE TOXICITY BY INHALATION

For a given species, the LC50 is the Concentration of an active substance that is Lethal (deadly) for 50 percent of a batch of laboratory animals subjected to testing after 4 hours of exposure via inhaled air.

The preferred animal species is the rat.

The LC50 is expressed in milligrams of active substance per liter of air.


3.6, 3.7 SKIN OR EYE IRRITATION

The substance's irritating effects are manifested on the skin by erythema or oedema and in the eyes by inflammation of the conjunctiva, corneal opacity, etc.

The substance's irritancy is documented by an approximation selected from a scale (from non-irritating to corrosive).

The preferred animal species is the rabbit.


3.8 SKIN SENSITISATION

This is a delayed skin hypersensitivity reaction that requires an initial exposure and that only develops upon subsequent exposure to the substance.

The result is expressed as an approximation selected from a scale (from non-sensitising to highly sensitising).

The selected animal species is the mouse or guinea pig (see test).


3.9 GENOTOXICITY

Définition

A mutation is a sudden, permanent, transmissible change in DNA that is spontaneous or induced.

Tests

The mutagenicity of the active substances tested is assessed by a battery of in vitro tests using bacteria, mammalian cells in culture and in vivo tests (on animals).

The properties explored are gene mutations, changes in structure and number of chromosomes, the phenomena of DNA repair and recombination.

in vitro tests can be performed with or without metabolic activation: the addition of a fraction of liver enzymes simulates the substance's metabolism in the mammalian body.

Risks to humans

Tests are marked as positive if they reveal a mutagenic nature. A comprehensive analysis of all the tests is needed to assess whether the substance is mutagenic to humans.

An opinion is issued on the risk to humans, by experts from the European Union or from other organisations such as the International Agency for Research on Cancer (IARC).

3.10 SHORT- and LONG-TERM TOXICITY AND CARCINOGENESIS

For a given species, the no observed adverse effect level (NOAEL) for a batch of laboratory animals tested during a specified period (from 1 month to 2 years), is the maximum amount of substance whose daily intake would have no adverse effects on the tested animals.

The NOAEL is expressed either in milligrams of active substance per kilogram of body weight of the tested animal per day, or in milligrams of substance per kilogram of food (ppm), if it is a dietary concentration.

The preferred animal species are the rat, mouse and dog.

TARGET FUNCTIONS OR ORGANS

In short- and long-term studies in different animal species, it is necessary to identify the organs (e.g. liver) or functions (e.g. blood clotting) targeted by the toxicity, and for which the type of lesions and the mechanism of action, if understood, are specified.

The liver and kidneys, which have important metabolic and excretory functions and are largely irrigated, are target organs with particularly high levels of exposure.

CARCINOGENESIS

Definition

A carcinogen is an agent capable of causing cancer or increasing its incidence in an exposed population. Cancer is characterised by the uncontrolled proliferation of abnormal cells, causing tumours in different organs.

Tests

Carcinogenesis studies are often combined with long-term studies.

Their aim is different because they involve identifying a possible carcinogenic effect of the substance and describing the type of tumours induced.

The target functions or organs in carcinogenesis are covered by their own section because they may differ from the targets in long-term studies.

3.11 REPRODUCTIVE TOXICITY

For a given species, the no observed adverse effect level (NOAEL) for a batch of laboratory animals tested during a specified period, is the maximum amount of substance whose daily intake would have no adverse effects on the tested animals.

In the case of teratogenesis studies, the NOAELs concern the pregnant female and development (embryo, foetus). The preferred animals are the rat and rabbit.

In the case of multigenerational studies (M2, M3), the NOAELs concern the parent generation, the offspring and the reproductive parameters. The preferred animal species is the rat.

The NOAEL is expressed either in milligrams of active substance per kilogram of body weight of the tested animal per day, or in milligrams of substance per kilogram of food (ppm).

3.12 NEUROTOXICITY

For a given species, the no observed adverse effect level (NOAEL) for a batch of laboratory animals tested during a specified period, is the maximum amount of substance whose daily or single intake would have no adverse effect on the tested animals.

The aim of neurotoxicity studies is to identify the effects on behaviour and/or any delayed toxicity after exposure to a substance.

The preferred animals species are the rat and chicken.

Tests are required for active substances whose mechanism of action is related to an interaction with the nervous system, such as substances that inhibit acetylcholinesterase activity.

The NOAEL is expressed in milligrams of active substance per kilogram of body weight of the tested animal per day or in milligrams of substance per kilogram of food (ppm).

3.13 OTHER STUDIES

In addition to the required studies, it is sometimes necessary to perform others, such as those to specify the toxic mechanism of action, or on the substance's metabolites in animals, water, plants and soil, or on any manufacturing impurities, so as to better understand their toxicological profile.

Studies should follow the OECD guidelines or suitable protocols, and must be performed in accordance with good laboratory practices.

3.14 ACCEPTABLE DAILY INTAKE: ADI

The ADI is the amount of a substance that can be ingested daily by the consumer, throughout a lifetime, without adverse effect on their health.

It is expressed in milligrams of active substance per kilogram of body weight per day.

It is calculated from a no observed adverse effect level (NOAEL) and a safety factor (SF).

The NOAEL used for the calculation is taken from the most appropriate study on a sensitive and representative animal species.

The safety factor takes into account intra- and inter-species variability and the nature of the substance's effects.

ADIs are set by the Commission of the European.


3.15 ACUTE REFERENCE DOSE: ARfD

The acute reference dose refers to the maximum amount of active substance that can be ingested by the consumer over a short period (i.e. during a meal or a day, in food or drinking water), without any adverse health effect.

It is expressed either in milligrams of active substance per kilogram of body weight.

It is calculated from a no observed adverse effect level (NOAEL) and a safety factor (SF). The NOAEL used for the calculation is taken from the most appropriate study on a sensitive and representative animal species. The safety factor takes into account intra- and inter-species variability and the nature of the substance's effects.

ARfDs are set by the Commission of the European Union.


3.16 ACCEPTABLE LEVEL OF EXPOSURE FOR THE OPERATOR, BYSTANDERS, WORKERS AND RESIDENTS: AOEL

The Acceptable Operator Exposure Level (AOEL) refers to the maximum amount of active substance to which the operator may be exposed daily without any adverse health effect.

It characterises an indicator of hazard to the operator, bystanders, farm workers and residents.

It is expressed in milligrams of active substance per kilogram of body weight per day, milligrams of substance per cubic meter or milligrams of substance per liter for gaseous substances.

It is calculated from a no observed adverse effect level (NOAEL) and a safety factor (SF). The NOAEL used for the calculation is taken from the most appropriate study on a sensitive and representative animal species. The safety factor takes into account intra- and inter-species variability and the nature of the substance's effects.

AOELs are set by the Commission of the European Union.


4 - BEHAVIOUR IN THE ENVIRONMENT


4.1 BEHAVIOUR IN SOIL

The aim is to identify the processes of degradation in soil and the compounds formed, as well as to characterise the persistence and mobility of the active substance and its major metabolites. Laboratory studies (in aerobic and anaerobic conditions, and those specific to photodegradation) may be supplemented by field studies.

The test item is usually the active substance; it may be one of its metabolites.

4.1.1 DEGRADATION PATHWAYS IN THE SOIL

  • The degradation pathway is represented by a table specifying the nature of the study (in the laboratory, under aerobic, anaerobic or field conditions) :

      • the percentage of mineralisation and the percentage of non-extractable residues,
      • the metabolites, and for each one :
        • its identity,
        • the maximum percentage reached,
        • the formation conditions.

4.1.2 RATE OF DEGRADATION IN THE SOIL

4.1.2.1 Degradation rate in the laboratory, under aerobic conditions
4.1.2.2 Degradation rate in the laboratory, under anaerobic conditions
4.1.2.3 Degradation rate in the field
4.1.2.4 Photodegradation rate in the laboratory

  • The degradation time 50% (DT50) is the time required for one half of the initial quantity of active substance (or 90% for the DT90) to degrade (in the laboratory) or dissipate (in the field) in the soil. It is calculated from the concentrations measured over time in a given soil. (In the field, dissipation includes the various degradation processes, and also, sometimes, the volatilisation or transfer of the substance through the soil.)

  • Soil characteristics and temperature are specified.

  • Degradation kinetics are given.

  • Photodegradation: the DT50 and DT90 in the dark under the same experimental conditions may be given for comparison. The nature of the light source and exposure conditions are specified.

4.1.3 MOBILITY IN THE SOIL: ADSORPTION

The adsorption coefficients, obtained in the laboratory, characterise the active substance's potential mobility :

  • Kd is the soil/water partition coefficient measured experimentally for a given soil (by bringing together a solution of the substance and a given mass of soil). It is usually expressed in mL/g.
    Koc is obtained by dividing Kd by the fraction of organic carbon (foc) in the soil (Koc = Kd / foc).
  • According to the Freundlich adsorption isotherm equation,
    S = Kf . Ce1/n
    where:
    • Kf: Freundlich adsorption coefficient,
    • 1/n: Freundlich exponent,
    • S: concentration of the substance adsorbed on the soil,
    • Ce: concentration of substance in solution at equilibrium.

Kfoc is obtained by dividing Kf by the fraction of organic carbon in the soil.
(Kf is equal to the linear adsorption coefficient Kd when the Freundlich exponent 1/n is equal to 1).

4.1.4 OTHER STUDIES OF MOBILITY IN SOIL

  • In the laboratory

The aim is to assess the potential mobility of the substance, especially when adsorption measurements obtained by the conventional batch technique are not available.

    • studies on soil columns

    Soil (generally reconstituted) is packed into a column of varying size (from a few centimeters to several tens of centimeters) and the substance is applied to the soil column surface. Then a quantity of water is leached through the column, and the leachate and residues in the soil column are analysed.

    • studies on soil columns using aged residues

    After the substance has been incubated, the "aged" substance is applied to the surface of a soil column. It then receives a quantity of water, and the leachate and the residues in the soil column are analysed.

  • In the field

The aim is to obtain information on mobility in the soil and the potential for leaching to groundwaters.

    • lysimeter studies

    A lysimeter is an isolated cylinder of soil. The size of this device may vary (typically it has an area of 1 m² and a depth of 1 m). Lysimeters can be placed outdoors (with precipitation and irrigation, if applicable) or in sheltered conditions (with a controlled water supplys).

    Usually the substance is applied for one or two years; the leachate collected under the lysimeter is analysed for two or three years, and the residues in the soil profile are analysed at the end of the study.

    • field leaching studies

    The treated plot is fitted with devices that take water samples from deep in the ground for analysis.

4.2 BEHAVIOUR IN WATER

The aim is to identify the degradation processes, compounds formed and their distribution between water and sediments.

4.2.1 HYDROLYSIS PRODUCTS

Main products formed in water at different pH (under sterile conditions).

4.2.2 HYDROLYSIS RATE

See Section 2.7

4.2.3 PHOTOLYSIS PRODUCTS IN WATER

Main products formed in water at a given pH under the influence of light (under sterile conditions).

4.2.4 PHOTOLYSIS RATE IN WATER

See Sections 2.8 and 2.9

4.2.5 EASE OF BIODEGRADATION

Biodegradability is assessed with the reference "readily biodegradable" or "not readily biodegradable".

4.2.6 DEGRADATION PATHWAYS IN THE WATER-SEDIMENT SYSTEM

The degradation pathway is represented by a table specifying the nature of the study :

      • the maximum percentage of active substance reached in the sediment phase (after application of the substance to the surface of the water),
      • the mineralisation percentage,
      • the percentage of non-extractable residues,
      • the metabolites, and for each one:
        • its identity,
        • the maximum percentage of the metabolite in the water and in the sediment,
        • the formation reaction.

4.2.7 DEGRADATION RATE IN THE WATER-SEDIMENT SYSTEM

4.2.7.1 Dissipation rate - aerobic conditions, darkness
4.2.7.2 Dissipation rate - aerobic conditions, light
4.2.7.3 Dissipation rate - anaerobic conditions, darkness
4.2.7.4 Dissipation rate - anaerobic conditions, light

  • Each phase of the water-sediment system is described (laboratory study).

  • The DT50 is the time needed for 50% of the initial quantity of active substance to dissipate in the water phase, in the sediment phase and in the overall system. (The substance added to the water becomes distributed between the water and sediment phases, and degrades in each phase).

  • Sediment characteristics, water pH, and temperature are specified.

4.3 BEHAVIOUR IN AIR

4.3.1 VAPOUR PRESSURE

See section 2.2

4.3.2 HENRY'S LAW

See section 2.3

4.3.3 DEGRADATION RATE IN AIR

  • The test item is usually the active substance ; it may also be one of its metabolites.

  • The DT50 is the time required for 50% of the initial quantity of active substance (or 90% for the DT90) to degrade.

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5 - ECOTOXICITY

5.1 EFFECT ON BIRDS AND OTHER TERRESTRIAL VERTEBRATES

  • The effects are evaluated primarily on birds:

      • 5.1.1 Acute oral toxicity
      • 5.1.2 Dietary toxicity
      • 5.1.3 Reproductive toxicity
      • 5.1.4 Other studies (i.e. field studies, palatability studies, etc).

  • The test item is usually the active substance (AS); it may also be one of its metabolites or a representative preparation.

  • The LD50 is the lethal dose for 50% of birds subjected to acute exposure.

  • The LC50 is the lethal concentration for 50% of birds subjected to short-term dietary exposure.

  • The NOEC is the No Observed Effect Concentration for reproduction in birds subjected to long-term dietary exposure.

  • The dose (with or without effect) is expressed in mg of test item per kg of body weight of the test animal. The concentration (with or without effect) is expressed in mg per kg of feed; it is converted to mg per kg of body weight of the test animal per day of exposure.
    .

5.2 EFFECTS ON AQUATIC ORGANISMS

  • The effects are assessed on the following aquatic organisms or systems:

    • 5.2.1 Fish

      • 5.2.1.1 Acute toxicity
      • 5.2.1.2 Chronic toxicity
      • 5.2.1.3 Bioaccumulation
      • 5.2.1.4 Other studies (if necessary)

    • 5.2.2 Aquatic invertebrates living in the water column or sediment (Daphnia, Chironomidae, etc)

      • 5.2.1.1 Acute toxicity
      • 5.2.1.2 Chronic toxicity
      • 5.2.2.3 Other studies (if necessary)

    • 5.2.3 Algae or aquatic plants

      • 5.2.3.1 Effects on growth (chronic toxicity)
      • 5.2.3.2 Other studies (if necessary)

    • 5.2.4 "Cosms"

      • 5.2.4.1 Effects on micro- and mesocosms.

  • The test item is usually the active substance (AS); it may also be one of its metabolites or a representative preparation.

  • The exposure type is :

    • S: static (medium not renewed)
    • D: dynamic (continuously renewed medium)
    • SS: semi-static (occasionally renewed medium).
  • The LC50 is the Lethal Concentration for 50% of exposed organisms, generally fish and some aquatic invertebrates.

  • The EC50 is the Effect Concentration for 50% of exposed organisms, generally Daphnia and other aquatic invertebrates, algae and aquatic plants. For invertebrates, the effect is immobilisation. For algae and plants, the measured effects are those on biomass (b), growth rate (r) or frond density (df) (e.g. ECb50).

  • NOEC is the No Observed Effect Concentration for all exposed organisms.

  • The BCF (bioconcentration factor) is determined at equilibrium. It is a dimensionless property that is determined on whole fish, possibly on the edible parts and viscera.

  • In the event of a probabilistic assessment, an HC5 (Hazard Concentration) is determined: this is the concentration limit at which 5% of organisms are affected (example criterion: 5% of organisations have an LC50 lower than the HC5).

  • For a microcosm or mesocosm, several endpoints can be determined, in particular:

    • NOEC
    • NOEAEC (no observed ecological adverse effect concentration).
  • The EAC (Ecologically Acceptable Concentration) is defined by considering all the studies on aquatic organisms.

  • The concentration is usually expressed in mg or µg of test item per liter of water, or sometimes in mg or µg of test item per kg of sediment. In some cases, when the item is a preparation, the result may be expressed in active substance (e.g. mg AS/L). If the concentration was verified analytically, the following details are given:

    • NC+ = nominal concentration verified analytically (measured concentration - nominal concentration < + or -20%)
    • MC = concentration measured, or more precisely:
      • MMC = mean measured concentration
      • IMC = initial measured concentration
      • FMC = final measured concentration.

    Otherwise, the following is indicated :

    • NC = NC- = nominal concentration (no information on the existence of any analytical verification or no analytical verification).

5.2.5 PREDICTED NO-EFFECT CONCENTRATION FOR AQUATIC ORGANISMS (PNEC)

The PNEC, Predicted No-Effect Concentration can be used to assess the risks to aquatic organisms.

PNEC means a concentration for which no effects on any aquatic organisms are expected.

The PNEC is determined by taking all the available information into account; it covers the potential effects of the active substance and its relevant metabolites. It is expressed in µg per liter, or in rare cases in µg per kg of sediment.

When the PNEC is defined on the basis of standard studies, it is calculated from the observed short-term (LC50 or EC50) or long-term (NOEC) effects on different taxonomic groups and using an appropriate safety factor (SF).

If the PNEC is based on a microcosm, mesocosm or on several cosms, the appropriate safety factor value is determined according to the quality of the information provided and the nature of the effects (usually between 1 and 5).

The PNEC of an active substance does not replace the specific determination of a preparation's PNEC.

5.3 EFFECTS ON BEES

  • The effects are assessed primarily on the honeybee with the following systems:

      • 5.3.1 Acute toxicity: oral exposure, contact exposure (topical application)
      • 5.3.2 Other studies (if necessary, i.e. tunnel or field, on brood, etc).
  • The test item is usually the active substance (AS); it may be one of its metabolites or a representative preparation.

  • The LD50 is the Lethal Dose for 50% of a batch of exposed bees. It is expressed in µg per bee.

5.4 EFFECTS ON TERRESTRIAL ARTHROPODS OTHER THAN BEES

  • Effects are determined on two benchmark species: a predatory mite (Typhlodromus pyri) and a parasitic wasp (Aphidius rhopalosiphi). If necessary, effects are studied on predatory species living in soil or on foliage. The test systems are:

        • 5.4.1 Effects in laboratory conditions: exposure on inert substrate or natural substrate
        • 5.4.2 Other studies: mixed field/laboratory studies and field studies.

  • The test item is almost always a preparation.

    • In the laboratory, the LD50, NED or a fixed-dose impact are determined:

        • The LD50 is the lethal dose for 50% of an exposed batch,
        • The NED is the No Effect Dose. Both values are expressed in g/ha,
        • The impact is a percentage of effect on survival or on a sub-lethal function (reproduction, parasitism, predation).


5.5 EFFECTS ON EARTHWORMS AND OTHER NON-TARGET SOIL MACROORGANISMS

  • The effects are assessed on earthworms and other soil macroorganisms:

        • 5.5.1 Acute toxicity
        • 5.5.2 Reproductive effects
        • 5.5.3 Other studies.

  • The test item is usually the active substance (AS); it may also be one of its metabolites or a representative preparation.

  • The LC50 is the Lethal Concentration for 50% of a batch of exposed earthworms.

  • The NOEC is the No Observed Effect Concentration for reproduction in a batch of exposed earthworms.

  • These two values are expressed in mg per kg of soil where the test item is incorporated into the soil, or in g/ha when the test item is sprayed onto the soil.

5.6 EFFECTS ON NON-TARGET SOIL MICROORGANISM
  • The effects are assessed on earthworms and other soil macroorganisms:

        • 5.6.1 Effects in laboratory conditions.

  • This is almost always studied in laboratory tests. The impact on microbial activity is assessed on the transformation of nitrogen (ammonification and nitrification) and on the mineralisation of organic carbon at a given concentration (mg/kg soil) or dose (g/ha).

5.7 EFFECTS ON OTHER NON-TARGET ORGANISMS (FLORA AND FAUNA)

  • This section includes information on the effects on all other non-target organisms (e.g. terrestrial plants).


5.8 EFFECTS ON BIOLOGICAL WASTEWATER TREATMENT METHODS

  • The EC50 is the 50% effect concentration on activated sludge (respiration inhibition). It is usually expressed in mg/L.

6 - REGULATORY VALUES


TOXICOLOGICAL CLASSIFICATION

Toxicological classification and labelling are issued by the Commission of the European Union, according to the criteria of European Regulation 1272/2008/EC and its adaptations.

Regulation 1272/2008/EC (the CLP Regulation) features some of the elements (labelling and criteria) of the new international classification system: the Globally Harmonized System (GHS). It replaces the current system for active substances (replacing Directive 67/548/EEC).


MAXIMUM RESIDUE LIMITS (MRLs)

European MRL website:
http://ec.europa.eu/sanco_pesticides/public/index.cfm?event=substance.selection