Registration Dossier
Registration Dossier
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EC number: 203-930-7 | CAS number: 112-04-9
Endpoint summary
Administrative data
Description of key information
No studies were available to assess the skin sensitisation potential of the test substance, however, data are available for the structural analogue substance triethoxy(methyl)silane (CAS 2031-67-6).
GPMT according to OECD TG 406: not sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No studies were available to assess the skin sensitisation potential of dimethoxydimethylsilane (CAS 1112-39-6), however, data are available for the structural analogue substance triethoxy(methyl)silane (CAS 2031 -67 -6).
Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
Studies were chosen as key when the available study was of relevance and of sufficient quality for classification, labelling and for risk assessment.
In a key guinea pig maximisation study conducted in compliance with GLP and according to OECD TG 406, the structural analogue substance triethoxy(methyl) silane was found to be a non-sensitiser. The sensitisation index was calculated to be 0% for the test group following challenge and rechallenge. A group of ten male and ten female guinea pigs was dosed with multiple intradermal injections on day 0 following a topical application on day 7 in order to investigate sensitisation potential of triethoxy(methyl) silane. The topical induction consisted of a 48 hour occluded dermal exposure to 0.5 ml of the test substance in a 50% (v/v) solution in sterile codex liquid paraffin. Eleven days after topical induction, challenge dosing for detection of sensitisation was performed. For challenge dosing, an essentially non-irritating concentration (10% (v/v)) of the test material was applied under occlusion for 24 hours. The test material vehicle, sterile codex liquid paraffin, was also found to be non-sensitising under the conditions of this study (Hazelton France, 1992b).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data available.
Justification for classification or non-classification
The available data on skin sensitisation of the structural analogue substance, triethoxymethylsilane, do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification of the registered substance.
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