Registration Dossier
Registration Dossier
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EC number: 202-859-9 | CAS number: 100-51-6
Carcinogenicity
Administrative data
Description of key information
In studies similar to OECD TG 451 male and female F344/N rats received daily 0, 200 and 400 mg/kg bw/day substance and male and female B6C3F1 mice received daily 0, 100 and 200 mg/kg bw/day benzyl alcohol, in both cases by gavage for 104 weeks. Under the conditions of these studies there was no evidence of carcinogenic activity (NTP TR 343, 1989).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
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
According to legal classification (Directive 67/548/EEC and Regulation (EC) No. 1272/2008) benzyl alcohol is not classified for carcinogenicity.
Based on the available data and according to criteria of Regulation (EC) No. 1272/2008, Annex I, classification for carcinogenicity would not be justified.
Additional information
There are carcinogenicity studies (2-year, similar OECD TG 451, NTP TR 343, 1989) in rats and mice available which were considered both for assessment purposes:
Male and female F344/N rats received daily by gavage 0, 200 and 400 mg/kg bw/day benzyl alcohol diluted in corn oil over a period of 104 weeks. Doses were selected based on the results of a subchronic toxicity study. The result is cited from the NTP-report: "Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of benzyl alcohol for male and female rats dosed with 200 or 400 mg/kg. Survival in both dose groups of female rats was 50% that of vehicle controls, primarily due to an increased number of gavage-related deaths."
Under the same conditions male and female B6C3F1 mice received daily by gavage 0, 100 and 200 mg/kg bw/day benzyl alcohol diluted in corn oil for 104 weeks (5 days/week). Again, the result is cited from the NTP-report: "There was no evidence of carcinogenic activity of benzyl alcohol for male or female B6C3F1 mice dosed with 100 or 200 mg/kg for 2 years."
Justification for selection of carcinogenicity via oral route endpoint:
No study is selected here, since both studies on carcinogenicity (2 y, rat and mouse, NTP TR 343, 1989) are relevant.
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