Registration Dossier
Registration Dossier
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EC number: 939-647-7 | CAS number: 1474044-68-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The substance bears no structural alerts for mutagenicity. Furthermore, OECD test guideline and GLP-compliant in vitro studies are available on a close analogue, sodium lauriminodipropionate:
. Gene mutation in bacteria:
S. typhimurium TA 1535, TA 1537, TA 98. TA 100, and TA 102, with and without metabolic activation, OECD 471 (1997): negative with and without metabolic activation.
. Gene mutation in mammalian cells:
HPRT, CHO, with and without metabolic activation, OECD 476: non mutagenic with and without metabolic activation.
. Cytogenicity in mammalian cells:
Chromosomal aberrations, V79, with and without metabolic activation, similar OECD 473: no mutagenic with and without metabolic activation.
There are no studies available investigating the in vivo genetic toxicity of the substance or sodium lauriminodipropionate. In accordance with Annex VII-IX of Regulation (EC) No 1907/2006, only in cases were evidence from in vitro tests (or other information) exist, testing in mammals is recommended. As no indication of mutagenicity was observed in the available test results or information, no further investigation is proposed.
Justification for selection of genetic toxicity endpoint
No study was selected, since all three in vitro studies were negative.
Short description of key information:
GENETIC TOXICITY IN VITRO
Gene mutation in bacteria:
S. typhimurium TA 1535, TA 1537, TA 98. TA 100, and TA 102, with and without metabolic activation, OECD 471 (1997): negative with and without metabolic activation
Gene mutation in mammalian cells:
HPRT, CHO, with and without metabolic activation, OECD 476: non mutagenic with and without metabolic activation
Cytogenicity in mammalian cells:
Chromosomal aberrations, V79, with and without metabolic activation, similar OECD 473: no mutagenic with and without metabolic activation
GENETIC TOXICITY IN VIVO
No information available, but complementary testing not required
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
All three in vitro studies were clearly negative up to limit test concentrations. Therefore the substance does not warrant any classification for genetic toxicity according to GHS (Regulation (EU) 1272/2008) or DSD (67/548/EEC).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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