Registration Dossier
Registration Dossier
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EC number: 221-337-1 | CAS number: 3069-33-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
An Ames test is available with N-[3-(methoxydimethylsilyl)propyl]ethylenediamine (CAS 3069-33-8).
The mutagenicity of N-[3-(methoxydimethylsilyl)propyl]ethylenediamine in bacteria was assessed in a study performed according to OECD Guideline 471 with Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 (LPT, 2002). The tester strains were treated using the plate incorporation and the preincubation method both with and without S9-mix. The concentrations tested were 10 - 1000 and 3.16 - 316 µg/plate for the plate incorporation and preincubation test, respectively. Results achieved with vehicle (DMSO) and positive controls were valid. No genotoxicity was observed in the presence and absence of metabolic activation. No precipitation was observed up to the highest dose tested. Cytotoxicity (defined as reduction of colonies by more than 50% and/or by a scarce background lawn) was observed in all strains at 1000 (plate incorporation) or 316 (preincubation) µg/plate. In the plate incorporation test cytotoxicity was observed at lower concentrations in TA 102 (-S9: 100 µg/plate; +S9: 316 µg/plate), TA 1535 (-S9: 316 µg/plate), TA 1537 (-S9: 316 µg/plate; +S9: 316 µg/plate). In the preincubation test cytotoxicity was observed at lower concentrations in TA 98 (-S9: 100 µg/plate), TA 102 (-S9: 100 µg/plate; +S9: 316 µg/plate), TA 1535 (-S9: 100 µg/plate; +S9: 316 µg/plate), TA 1537 (+S9: 316 µg/plate).
In conclusion, N-[3-(methoxydimethylsilyl)propyl]ethylenediamine did not induce mutations in bacteria under the test conditions applied.
Justification for selection of genetic toxicity endpoint
The available in vitro data fulfil the standard requirements given in Annex VII of Regulation (EC) 1272/2008. Therefore the mutagenicity study was chosen under "Endpoint selection" in accordance with ECHA, Practical guide 14, Version 1, 2012.
Short description of key information:
Mutagenicity in bacteria (OECD 471, Ames): S. typhimurium strains: TA 98, TA 100, TA 102, TA 1535 and TA 1537: negative with and without metabolic activation
Mutagenicity in mammalian cells: no data
Clastogenicity in mammalian cells: no data
Mutagenicity/clastogenicity in vivo: no data
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The available in vitro data are reliable and suitable for classification and fulfil the standard requirements given in Annex VII of Regulation (EC) 1272/2008. Based on the available data, there is no indication that the substance induces genetic toxicity. Nevertheless, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 or Directive 67/548/EEC can be made, as no information on mutagenicity and clastogenicity in mammalian cells/in vivo is available.
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