Registration Dossier
Registration Dossier
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EC number: 915-316-2 | CAS number: -
Carcinogenicity
Administrative data
Description of key information
No study totally compliant with the guideline requirements for a carcinogenicity study is available. There is some limited information from a chronic toxicity/carcinogenic study in rat, albeit of reliability 3 according to Klimisch cotation criteria due to significant deficiencies, which could suggest that no carcinogenic effects are expected.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There is no evidence of a carcinogenic effect of the reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane based on the results of a chronic toxicity/carcinogenic study albeit of reliability 3 according to Klimisch criteria. Therefore no classification for carcinogenicity is required according to the classification criteria of Annexe VI Directive 37/548/EEC or EU Regulation 1272/2008 (CLP).
Additional information
One chronic toxicity/carcinogenic study (combined with a satellite repro-fertility experiment), of reliability 3 according to Klimisch cotation criteria, is available (Mossinger, 1977). In this study the test substance was administered in the diet for 24 months to Wistar rats (20/sex/dose) at a single dose level of 100 ppm (corresponding to approximately 5 mg/kg bw/day). Control group (20 rats/sex) received diet without test substance. In addition, 98 rats (35 males and 63 females) from 14 to 38 months old completed the historical data on the used strain. Six animals were euthanized after 6-month exposure. Two treated males died during the exposure period: one for unknown reasons while incipient acute mycoplasmic bronchopneumonia was observed in the second animal. One female also died during the exposure and chronic typhlitis was observed at necropsy. No haematological abnormalities were observed but values were not reported. There was no treatment related increase in tumor incidence at macroscopic and microscopic pathological examinations when compared to controls. In particular, malignant tumors observed in two treated males (one pulmonary reticulolymphosarcomas and one interstitial tumor of the testis) represented a rate of 5% which was lower that the negative control rate (7.5%). Despite this study does not satisfy the guideline requirement for a carcinogenicity study OECD453 in rat to due to significant deficiencies (e.g. only a single low dose tested) these results could suggest that no carcinogenic effects are expected.
Justification for selection of carcinogenicity via oral route endpoint:
No carcinogenicity study is required since the substance is not mutagenic and no hyperplasia or pre-neoplastic lesions were observed in any available studies.
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