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Description of key information

Key value for chemical safety assessment

Additional information

There are no human or non-human carcinogenicity data available for the test material.

The test material has been evaluated in vitro and in vivo assays and did not give evidence of genotoxicity.

A European Union Risk Assessment Report for Primary Alkyl amines (DRAFT dated October 2008) evaluated the potential carcinogenicity of substances closely related to the test material. These materials were Amines, Tallow Alkyl; Amines, Coco Alkyl; Octadec-9-enylamine; Octadecylamine, and Amines, Hydrogenated Tallow Alkyl. The draft conclusion from the report follows:

 

There are no human data on the carcinogenicity of the alkylamines assessed in this report.

There are no conventional carcinogenicity studies in rodents with compliance to the current standard of test guidelines for this endpoint on the alkylamines assessed in this report.

Earlier studies on the chronic toxicity of octadecylamine, the main C18-component of hydrogenated tallow alkylamines (content of 60%) (Deichmann et al., 1958: oral S-D rats, doses up to 25 mg/kg bw, 2 years; MacDonald et al., 1962: oral, S-D rats, doses up to 25 mg/kg bw, 2 years) provide no indication of a carcinogenic effect.

No positive potential for carcinogenicity was predicted for octadecylamines and octadecenylamines from the Danish QSAR database.

Due to the lack of reliable data no final conclusion can be drawn on the carcinogenic potential of any of the fatty alkylamines under consideration. Negative data from mutagenicity and sparce data from chronic toxicity do not give a concern that alkylamines may have a carcinogenic potential.

Justification for classification or non-classification