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Registration Dossier
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EC number: 203-233-8 | CAS number: 104-75-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In a Weight of Evidence approach it was demonstrated that the test item did not show any mutagenic activity in the bacterial reverse mutation assay (Ames test) with and without metabolic activation.
The structural analogue substance, N-octylamine, did not induce mutation at the hprt locus of L5178Y mouse lymphoma cells under test conditions employed in this study. This included treatments up to highly toxic concentrations in two independent experiments, in the absence and presence of a rat liver metabolic activation system.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
A reliable and suitable study with the structural analogue substance, N-octylamine, exists showing no clastogenic or aneugenic activity in the in vivo Mammalian Erythrocyte Micronucleus Test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In vitro studies:
2-ethylhexylamine was evaluated for mutagenicity in the Salmonella/microsome preincubation assay using a standard protocol approved by the National Toxicology Program. Doses of 0, 10, 33, 100, 333, 1000, 1666, 3333 µg/plate were tested in four Salmonella typhimurium strains (TA98, TA100, TA97, and TA1537) in the presence and absence of Aroclor-induced rat or hamster liver S9. Under the experimental conditions, 2-ethylhexylamine did not show any mutagenic activity in the bacterial reverse mutation test with and without metabolic activation on the 5 tested strains. The positive controls gave the expected values (Zeiger et al. 1988; reliability score: 2).
A second Ames test of 2-ethylhexylamine to induce reverse mutation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 and E. coli CM891
was performed in accordance with the international guidelines (OECD 471) and in compliance with the principles of GLP. 2-ethylhexylamine was tested in two independent experiments, with and without a metabolic activation system, according the preincubation method (30 min at 37°C). Strains were exposed to 2-ethylhexylamine at 5, 15, 50, 150, 500, 1500, 5000 µg/plate (three plates/dose-level). After 48 hours of incubation at 37°C, the revertant colonies were scored. No noteworthy increase in the number of revertants was observed for all doses with and without metabolic activation on the (Huntingdon 1999; reliability score: 2)
There are no data for 2 -ethylhexylamine on in vitro mutagenicity in mammalian cells and in vitro cytogenicity available. However, there is sufficient information available from a close structural similar substance.
A study on mutagenicity in mammalian cells (HPRT-test according to OECD TG 476) is currently being performed at COVANCE on behalf of the consortium. This test is thought for read-across from Octylamin to Ethylhexylamin. Additionally, other HPRT-tests are also currently being performed so that the primary amines can be evaluated as a category together.
N-octylamine did not induce mutation at the hprt locus of L5178Y mouse lymphoma cells in a valid study that was conducted in accordance with OECD test guideline No. 476 and under GLP conditions. This included treatments up to highly toxic concentrations in two independent experiments, in the absence and presence of a rat liver metabolic activation system. Vehicle controls and positive control substances performed as expected (Covance, 2010). The study is considered to be valid and acceptable for assessment.
In vivo studies:
For N-octylamine hydrochloride an in vivo Mammalian Erythrocyte Micronucleus Test (OECD 474) in mouse has been performed (BASF, 2007) which is used for read-across. Under the experimental conditions chosen the test substance N-octylamine hydrochloride has no chromosome-damaging (clastogenic) effect nor does it lead to any impairment of chromosome distribution in the course of mitosis (aneugenic activity) in bone marrow cells in vivo. The test was negative.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. As a result the test substance are not considered to be classified as mutagenic under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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