Division 3.9.2.6 In exceptional cases, based on expert judgement, it is appropriate to place certain substances with human evidence of specific target organ toxicity in Category 2:
United Kingdom
- (a)
when the weight of human evidence is not sufficiently convincing to warrant Category 1 classification; and/or
- (b)
based on the nature and severity of effects.
Dose/concentration levels in humans shall not be considered in the classification and any available evidence from animal studies shall be consistent with the Category 2 classification. In other words, if there are also animal data available on the substance that warrant Category 1 classification, the substance shall be classified as Category 1.