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Administrative data

Key value for chemical safety assessment

Additional information

Data on mutagenicity testing with dodecylamines are not available. However, with analogous primary alkylamines only negative results were obtained in both, in vitro and in vivo. C12 -18 -(even numbered)-alkylamines have been shown to be not mutagenic in bacterial gene mutation testing. Likewise only negative results from tests on bacterial mutagenicity and negative data on gene and chromosome mutations in mammalian cells in vitro and on chromosomal aberrations and micronuclei in vivo were revealed for the whole category of primary alkylamines. Alltogether, the negative data on primary alkylamines are considered as sufficient to exclude a mutagenic potential of dodecylamines in vivo. This conclusion is in line with the existing EU risk assessment on primary alkylamines in general.

Short description of key information:
No study reports concerning mutagenicity testing of dodecylamines are available. However, data from closely related primary alkylamines can be used for assessment based on read-across. C12-18-(even numbered)-alkylamines, C16-18-(even numbered, C18-unsaturated)-alkylamines as well as octadecylamines were tested for gene mutation in Salmonella typhimurium strains and E. coli with and without metabolic activation. No increases in the number of revertants were induced in any of the tester strains used. Data from (Z)-octadec-9-enylamine (CAS No. 112-90-3) indicate absence of mutagenicity at the hprt locus in mammalian CHO cells up to 10 nl/ml with and without S9-mix.

Negative results for mutagenicity of (Z)-octadec-9-enylamine (CAS No. 112-90-3) were obtained in a valid L5178Y TK+/- mouse lymphoma assay in the presence and absence of metabolic activation. No increases in mutation frequency as compared to solvent controls were found. Additionally, (Z)-octadec-9-enylamine (CAS No. 112-90-3) did also not induce chromosomal aberrations in a valid cytogenetic study in vitro in CHO cells in the presence and absence of aroclor 1254 induced rat liver S9-mix.

Data from in vivo mutagenicity studies on dodecylamines are not available. However, no indications of a related potential exist from analogous compounds. A GLP-compliant bone marrow micronucleus test with tallow alkylamines (CAS No. 61790-33-8) in 50 Sprague Dawley rats led to a negative result after a single oral dose of 2000 mg/kg body weight.

Negative results are also reported from an in vivo chromosomal aberration test in mice. Administration of single doses up to 5000 mg/kg body weight in corn oil via gavage revealed no significant increases in aberrant cells although clinical signs of toxicity indicated that the test material was systemically available after oral application. Based on all available data, a mutagenic potential for dodecylamines as well as for primary alkylamines in general is not deducible.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available database confirming the absence of a mutagenic potential in vitro as well as in vivo, respective classification of dodecylamines, as well as of the whole category of primary alkylamines, is not warranted.