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1. Account should be taken of the physico-chemical properties of a substance, as well as reports of accidental poisonings in people and acute toxicity tests in animals. In the absence of adequate human experience, allocation should be based on data obtained from animal experiments. Acute toxicity testing in animals should be conducted using internationally-agreed protocols, such as the current edition of the Organisation for Economic Co-operation and Development’s Guidelines for Testing of Chemicals, and in accordance with appropriate animal welfare provisions.
2. When a substance exhibits a different order of toxicity by two or more of the following routes of administration, namely oral, dermal or inhalation, the highest degree of danger indicated by the tests shall be considered when allocating the substance.
3. Subject to paragraphs 1 and 2 above, toxic and harmful substances shall be allocated into packing groups I, II or III in accordance with the criteria given in the table below:
Classification | Packing Group | Oral toxicity LD50 (mg/kg) | Dermal toxicity LD50 (mg/kg) | Inhalation toxicity of dust or mists LC50 (mg/L) | Inhalation toxicity of vapours where V is the saturated vapour concentration produced by the substance at 20°C expressed by reference to LC50 (ml/m3) |
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The above criteria are based on LC50 data relating to one hour exposure and where such information is available it should be used. However, where only LC50 data relating to 4 hour exposures is available then:
| |||||
Toxic Substance | I | ≤5 | ≤40 | ≤0.5 | V≥10.LC50 and LC50≤1000 |
II | >5 to ≤50 | >40 to ≤200 | >0.5 to ≤2 | V≥LC50 and LC50 ≤3000 but not placed in packing group I | |
Harmful substance | III | solids: >50 to ≤200 liquids: >50 to ≤500 | >200 to ≤1000 | >2 to ≤10 | V≥0.2LC50 and LC50 ≤5000 but not placed in either packing group I or II |
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