Registration Dossier
Registration Dossier
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EC number: 220-168-0 | CAS number: 2650-18-2
Carcinogenicity
Administrative data
Description of key information
Not carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Species:
- mouse
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Species:
- mouse
Justification for classification or non-classification
No carcinogenic effects were observed at dose levels exceeding the limit dose in life-long feeding studies in rats and mice. As a result the substance is not classified for repeated dose toxicity under CLP Regulation (EC n.1272/2008).
Additional information
The following reported data were obtained for Similar Substance 1. It is expected that the Target substance will present similar effects of carcinogenicity. Justification for Read Across is given in Section 13 of IUCLID.
For carcinogenicity properties, Borzelleca (1990) study already quoted in repeated dose toxicity endpoint, has been chosen as key study.
In the study a life-time feeding study in rats with dietary concentrations of 0.1, 1 and 2% (w/w) published by Borzelleca et al (1990). The study design includes the requirements of OECD testing guideline 453, and includes additional fertility and developmental toxicity elements. The chronic toxicity study started with in-utero exposure. Parental animals (each 60 males and females) were exposed via the diet during pre-mating, mating and pregnancy for a total period of 2 months. Then the offspring (70 males and 70 females) was weaned onto the test-material containing diet and kept on this diet for life-long exposure (30 months). For each ten male and female rats, an interim sacrifice was performed after 12 months. Calculated from the body weights, the doses for males were 0, 50, 514, 1072 mg/kg bw and those for females were 0, 62, 631, 1319 mg/kg bw.
During the study, there was blue staining of fur, feces and exposed skin which is caused by the blue color of the test substance. There were no adverse observations regarding clinical signs, mortality, urinalysis, haematology, clinical chemistry, ophthalmoscopy, organ weights and histopathology. High dose animals showed a slightly higher food consumption. After week 90, mean body weights of the 2.0% females began a steady downward trend that was statistically significant (P < 0.01) from week 102 until the end of the study; terminal body weights were 15% lower compared to control group animals. High dose females showed a reduced survival rate (10/70 versus 28/70 and 24/70 in two control groups) compared to the control group.
The same authors also published the results of a life-long feeding study in mice with 0.5, 1.5, and 5% (w/w) in the diet, and it only included parameters related to carcinogenic properties. No adverse findings were noted in that study. Calculated for daily uptake per kg body weight, doses were 0, 661, 2064, 7354 mg/kg bw for males and 0, 819, 2562, 8966 mg/kg bw for females.
Another supporting study is reported for Similar Substance 1 published by Mannell (1964).Four groups of 15 male and 15 female Wistar rats, four to six weeks old, were fed diets containing 0 (control), 0.03, 0.3 or 3% of test substance for 75 weeks, at which time the experiment was terminated. The numbers of survivors at this time were 23 (control), 19, 20 and 19 rats in the four groups, respectively; tissues from five male and five female survivors in each group were examined histologically. One lymphosarcoma occurred in a male fed the 0.3% dose level. The study is not considered as key study since inadequate histological examination of tissues in this experiment are noted.
Carcinogenicity for dermal route has been investigated by Carson (1984) in a skin painting supporting study in mice. The tested doses were very low (50 mg/kg bw) since the dose was chosen for assessment of use in lipsticks. Dermal application of 1 mg per mouse twice per week for 18 months did not cause skin cancer. Full histopathology of a low number of randomly chosen animals did not give an indication of systemic toxicity or carcinogenicity.
In conclusion, no carcinogenicity was observed for Similar Substance 1 in all studies reported.
References:
- Borzelleca, J.F. et al. 1990.Lifetime Toxicity/Carcinogenicity Studies of FD&C Blue no. 1 (Brilliant Blue FCF) in Rats and Mice.Fd. Chem. Toxicol.28, 221-234.
- Carson, S. 1984. Skin Painting Studies in Mice with 14 FD&C and D&C Colors.J. Toxicol. - Cut. and Ocular Toxicol.3, 357 – 370.
- Mannell et al. 1964. Chronic toxicity studies on food colours. V. Observations on the toxicity of Brilliant Blue FCF, Guinea Green B and Benzyl Violet B in rats.J. Pharm. Pharmacol.16: 56-59.
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