Report from the Sub-comittee on the environment and health

• Toxic effect on terrestrial organisms: acute toxicity in worms, effect
on soil respiration, effect on ammonification, effect on nitrification,
effect on asymbiotic N-fixation and, in some cases, effect on
symbiotic N-fixation.
• Toxic effect on birds: toxicity caused by food intake in species with
different food resources (2 species), reproduction test (1 species).
The following toxicological data for assessment of effects on humans
must be provided for <strong>the</strong> active ingredient:
1) Acute toxicity
Toxicity with a single dose of <strong>the</strong> substance. Measured as LD50 (<strong>the</strong> dose
needed for half <strong>the</strong> animals to die). Must be tested in separate tests with
swallowing, skin contact and inhalation.
2) Local irritation
Skin irritation, eye irritation and allergenic properties in connection with
skin contact must also be investigated.
3) <strong>Sub</strong>-chronic toxicity
Toxicity with daily dosing for 3-6 months. Two tests are required: one on
rats (of 3 months duration ) and one on non-rodents (e.g. dogs) of 3-6
months duration.
4) Chronic toxicity
Toxicity with long-term dosing. Chronic toxicity and carcinogenicity are
often combined in <strong>the</strong> same 2-year test. Two tests are required on
different species of mammal. If dogs are more sensitive than rats, a
separate 1-year toxicity test on dogs is required.
5) Carcinogenic effect
6) Mutagenicity
The ability of <strong>the</strong> substance to cause damage to <strong>the</strong> genetic material.
Must be tested in test-tube tests (in vitro) and in animal tests (in vivo). If
<strong>the</strong> substance is found to be positive in <strong>the</strong> above tests, it must be tested
in gametes.
7) Tests on impairment of fertility
Multi-generational tests; <strong>the</strong> possible ability of <strong>the</strong> substance to reduce
fertility must be tested by feeding with <strong>the</strong> substance through several
generations.
8) Teratogenicity tests
The ability of <strong>the</strong> substance to damage <strong>the</strong> foetus during pregnancy must
be tested in two species of mammal. The pregnant dam must receive <strong>the</strong>
substance by tube in <strong>the</strong> most sensitive period of <strong>the</strong> pregnancy.
9) Neurotoxicity
Particularly for <strong>the</strong> so-called cholinesterase inhibitors.
10) Toxicity of any metabolites, degradation products and impurities.
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