Registration Dossier
Registration Dossier
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EC number: 701-459-6 | CAS number: -
Carcinogenicity
Administrative data
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
Justification for classification or non-classification
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
