Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

With regard to mutagenicity, only negative results were obtained for primary alkylamines in both, in vitro and in vivo. Octadecylamines have been shown to be not mutagenic in bacterial gene mutation testing. Likewise only negative results from tests on bacterial mutagenicity and 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 are considered as sufficient to exclude a mutagenic potential of octadecylamines in vivo. This conclusion is in line with the existing EU risk assessment on primary alkylamines in general.


Short description of key information:
Octadecylamines were tested in a GLP compliant bacterial gene mutation test (Ames-test) in Salmonella typhimurium TA 100, TA 1535, TA 1537, TA 1538, TA 98 and E. coli WP2uvrA according to OECD TG 471 with and without endogenous metabolic activation (S9-mix from Aroclor-induced rat liver). No increases in the number of revertants were induced in any of the tester strains used.

No data is available for octadecylamines in other test systems. However, data from closely related primary alkylamines can be used based on read-across. 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 also 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 octadecylamines are not available. However, based on read-across 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.

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 octadecylamines, as well as of the whole category of primary alkylamines, is not warranted.