Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study technically not feasible
Justification for data waiving:
other:

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name: Carbamic acid, N-(3-(triethoxysilyl)propyl)2-(ethyl-(4-nitrosophenyl) amino) ethyl ester
- CAS 1195231-94-7

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, an acute dermal toxicity study according to OECD 402 is not performed due to the molecular weight of the substance and experience from acute oral toxicity testing. Based on expert judgement, nitrososilane is not considered to be hazardous after single dermal exposure.
Executive summary:

Acute oral toxicity

The test item nitrososilane was investigated for its potential acute oral toxicity in rats following the protocol of OECD method 423 (Henkel, 2013). All animals survived a dose of 2000 mg/kg until the end of the study. The median lethal dose (LD50) was found to be above 2000 mg/kg bw, which does not require classification under the EU regulation (Regulation (EC) 1272/2008). The substance has to be classified in category 5 for acute toxicity under the Globally Harmonized System of Classification and Labelling of Chemical Substances of the United Nations (UN-GHS).

Acute dermal toxicity - waiving

Testing is technically not feasible and unnecessary animal testing can be avoided because it is difficult that the substance passes through the skin barrier. Nitrososilane is a green solid powder with a molecular weight of 442 g/mol. Substances with a molecular weight of >= 500 g/mol cannot easily pass the skin barrier. The nitrososilane is close to this threshold value and, therefore, no relevant dermal availability is expected for this substance. Taking the expected low dermal availability into account and considering the result of the acute oral toxicity study, it is not expected that the nitrososilane is hazardous after single dermal exposure. We do not expect the median lethal dose to reach a value below 2000 mg/kg.

Conclusion

In conclusion, an acute dermal toxicity study according to OECD 402 is not performed due to the molecular weight of the substance and experience from acute oral toxicity testing. Based on expert judgement, nitrososilane is not considered to be hazardous after single dermal exposure.