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Carcinogenicity

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Description of key information

A conduct of a carcinogenicity study is not considered necessary, due to the inert character of the test substance and the lack of genotoxicity in several in vitro assays.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In accordance with Annex X of REACH Regulation 1907/2006, section 8.9.1, a carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if: 

- the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and 

- the substance is classified as germ cell mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

Pigments are not bioavailable. Pigment Yellow 53 belongs to a family of rutile pigments that has been tested for ion leaching (please refer to IUCLID section 7.9.3) and has been exempted from classification based on non-availability of ion toxicophores. The heavy metal oxides (used for pigment manufacturing) are absorbed by the rutile lattice and thus lose their chemical, physical, and physiological properties. Furthermore the pigment shows a very low water solubility being practically physiologically inert.

Results from a 90 d repeated dose study and a reproductive screening study further support that the substance is not bioavailable (see IUCLID section 7.5 and 7.8), because it did not result in hyperplasia or other pre-neoplastic lesions. Additionally, no genetic toxicity was observed in the available in vitro tests in bacteria and mammalian cells.

Thus, a conduct of a carcinogenicity study is not considered necessary.

Justification for classification or non-classification