Registration Dossier

Administrative data

Description of key information

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

OECD TG 406: not sensitising

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 Regulations (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 trimethoxy(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:

Studies were chosen as key when the available study was of relevance and of sufficient quality for classification and labelling and for risk assessment.

No studies were available to assess the skin sensitisation potential of trimethoxyphenylsilane, however, data are available for the structurally related substance dimethoxydiphenylsilane (CAS: 6843-66-9). Both substances hydrolyse in contact with water to produce silanol hydrolysis products which are structurally similar, phenylsilanetriol and diphenylsilandiol. Therefore, it is considered that read-across between the substances is appropriate.

A key skin sensitisation study, conducted in compliance with GLP and according to OECD TG 406, found the structural analogue substance dimethoxydiphenylsilane (CAS: 6843-66-9) was not a skin sensitiser.The sensitisation index was calculated to be 0% for the test group following challenge. Appropriate positive and solvent controls were included and gave expected results(Prüfinstitut für Toxikologie, 1995).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation of the structural analogue substance, dimethoxydiphenylsilane (CAS: 6843-66-9), do not meet the criteria for classification according to Regulation (EC) 1272/2008 or EU Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification of the registered substance.