Division 3.6.2.1 For the purpose of classification for carcinogenicity, substances are allocated to one of two categories based on strength of evidence and additional considerations (weight of evidence). In certain instances, route-specific classification may be warranted, if it can be conclusively proved that no other route of exposure exhibits the hazard.
United Kingdom
| Table 3.6.1 | |
| Hazard categories for carcinogens | |
| Note: See 3.6.2.2.4. | |
| Categories | Criteria |
|---|---|
| CATEGORY 1: | Known or presumed human carcinogens A substance is classified in Category 1 for carcinogenicity on the basis of epidemiological and/or animal data. A substance may be further distinguished as: |
| Category 1A: | Category 1A, known to have carcinogenic potential for humans, classification is largely based on human evidence, or |
| Category 1B: | Category 1B, presumed to have carcinogenic potential for humans, classification is largely based on animal evidence. |
| The classification in Category 1A and 1B is based on strength of evidence together with additional considerations (see section 3.6.2.2). Such evidence may be derived from:
| |
| In addition, on a case-by-case basis, scientific judgement may warrant a decision of presumed human carcinogenicity derived from studies showing limited evidence of carcinogenicity in humans together with limited evidence of carcinogenicity in experimental animals. | |
| CATEGORY 2: | Suspected human carcinogens The placing of a substance in Category 2 is done on the basis of evidence obtained from human and/or animal studies, but which is not sufficiently convincing to place the substance in Category 1A or 1B, based on strength of evidence together with additional considerations (see section 3.6.2.2). Such evidence may be derived either from limited evidence of carcinogenicity in human studies or from limited evidence of carcinogenicity in animal studies. |
Annotations
Footnotes
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Note: See 3.6.2.2.4.