Registration Dossier

Administrative data

Description of key information

No studies were available to assess the skin sensitisation potential of the substance, however, data are available for the structurally related substance dimethoxydiphenylsilane (CAS: 6843-66-9).

Buehler test (OECD TG 406, GLP): not sensitizing

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
Reason / purpose:
read-across source
Reading:
1st reading
Hours after challenge:
30
Group:
negative control
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
30
Group:
test group
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
54
Group:
negative control
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
54
Group:
test group
Dose level:
100% (v/v)
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
Executive summary:

One study is available from structural analogue dimethoxy(diphenyl)silane CAS 6843 -66 -9. It is concluded that dimethoxy(diphenyl)silane and triethoxy(phenyl)silane are not skin sensitising. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the skin sensitising potential that are higher than the typical experimental error of the test method.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No studies were available to assess the skin sensitisation potential of triethoxy(phenyl)silane (CAS: 780-69-8), however, data are available for the structurally related substance dimethoxy(diphenyl)silane (CAS: 6843-66-9). Both substances are moisture sensitive liquids that hydrolyse to produce hydrolysis products which are also structurally similar. Triethoxy(phenyl)silane produces ethanol and phenylsilanetriol, while dimethoxy(diphenyl)silane produces methanol and diphenylsilanediol. Therefore, it is considered that read-across between the substances is appropriate. Neither methanol nor ethanol is sensitising in standard test species for REACH endpoints and are therefore not taken into account for further assessment of this endpoint.

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.

 

In the key study to assess skin sensitization a Buehler test according OECD TG 406 and in compliance with GLP was performed (Eisele, 1995c, RL2). Female Dunkin Hartley guinea pigs were treated (20/10 control/test group) thrice with 300 µl of the analogue substance dimethoxydiphenylsilane every 7 days during the induction period. The test substance was applied undiluted for 6 hours under occlusive conditions. In a pretest the substance was found to be not irritating when applied undiluted. Two weeks after the last induction one challenge was performed in the same way as the induction procedure. 30 and 52 hours after the beginning of the challenge the skin reactions were scored. No reactions were observed at any time point and in any animal. In conclusion, the test substance is considered not to be a skin sensitizer under the applied conditions.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation of the registered substance do not meet the criteria for classification according to Regulation 1272/2008, and are therefore conclusive but not sufficient for classification.