Registration Dossier
Registration Dossier
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EC number: 231-494-8 | CAS number: 7585-41-3
Carcinogenicity
Administrative data
Description of key information
No reliable data regarding carcinogenicity is available for Pigment Red 48:1. Based on studies performed with members of the same category it can be concluded that Pigment Red 48:1 is not carcinogenic. Furthermore, data indicates that strontium is not carcinogenic.
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
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Because, no carcinogenicity has been observed and the substance is also not genotoxic, the substance is not considered to be classified for carcinogenicity according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.
Additional information
Oral
Feeding studies on carcinogenic properties in rats and mice are available for the sodium salt of Pigment Red 57 (CTFA 1981a and b). The study in rat was designed to meet US FDA requirements for long-term feeding studies, it combines a fertility element, in-utero-exposure and long-term exposure of the offspring. All parameters required for OECD testing guideline 453 are addressed. The design of the study in mice meets all requirements of OECD testing guideline 451. The purity of the test substance was reported to be 95% and stability in the feed was verified analytically. The studies were initiated prior to the introduction of Good Laboratory Practice in 1981. During the course of the study, GLP was introduced and so the last part was performed under GLP. In both studies, no indication of carcinogenic properties was observed after life-long feeding of 0, 0.05, 1 and 5 % in the diet to mice and after 0.05, 0.3 and 2.0 % in the diet to rats.
Skin painting
No indication of carcinogenic properties was observed in a skin painting study in mice with Pigment Red 57:1(CA) (Carson 1984). The investigation was performed prior to introduction of GLP. Limited details are given in the literature publication. The study was designed by the US competent authority and an industry association to assess the safety of the use in lipstick. For 18 months, mice were given 0.1 ml of an aqueous solution of 1% onto an area of 6 cm2 twice per week. This corresponds to a dose of 1 mg per mouse (50 mg/kg bw) per treatment. Full histopathology was only performed for 5 of 50 animals per dose group.
Strontium
Absence of carcinogenicity was reported in a 3 -year drinking water study with strontium chloride hexahydrate (Skoryna 1981).
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