Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: dermal
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:
- 2 013
Materials and methods
Test material
- Reference substance name:
- [SPEC][/SPEC][SYN]Nitrososilane[/SYN]
- IUPAC Name:
- [SPEC][/SPEC][SYN]Nitrososilane[/SYN]
- Reference substance name:
- [CS]000000419807[/CS]
- IUPAC Name:
- [CS]000000419807[/CS]
- Details on test material:
- - Name: Carbamic acid, N-(3-(triethoxysilyl)propyl)2-(ethyl-(4-nitrosophenyl) amino) ethyl ester
- CAS 1195231-94-7
Constituent 1
Constituent 2
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.
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