Division 3.6.2.2 Specific considerations for classification of substances as carcinogens

United Kingdom

1. 3.6.2.2.1Division 3.6.2.2.1
2. 3.6.2.2.2Division 3.6.2.2.2
3. 3.6.2.2.3Strength of evidence involves the enumeration of tumours in human and animal studies and determination of their level of statistical significance. Sufficient human evidence demonstrates causality between human exposure and the development of cancer, whereas sufficient evidence in animals shows a causal relationship between the substance and an increased incidence of tumours. Limited evidence in humans is demonstrated by a positive association between exposure and cancer, but a causal relationship cannot be stated. Limited evidence in animals is provided when data suggest a carcinogenic effect, but are less than sufficient. The terms ‘sufficient’ and ‘limited’ have been used here as they have been defined by the International Agency for Research on Cancer (IARC) and read as follows:
4. 3.6.2.2.4Division 3.6.2.2.4
5. 3.6.2.2.5Division 3.6.2.2.5
6. 3.6.2.2.6Some important factors which may be taken into consideration, when assessing the overall level of concern are:
7. 3.6.2.2.7Division 3.6.2.2.7
8. 3.6.2.2.8Division 3.6.2.2.8
9. 3.6.2.2.9Division 3.6.2.2.9