Registration Dossier

Administrative data

Description of key information

No studies were available to assess the skin or eye irritation potential of the substance, however, data are available for the structurally related substance trimethoxy(phenyl)silane (CAS: 2996 -92 -1).

OECD TG 404: not irritating
OECD TG 405: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
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
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable.
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable.
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema, oedema, or other dermal effects were noted at any exposure site. The primary irritation score was zero.
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 trimethoxyphenylsilane CAS 2996 -92 -1. It is concluded that trimethoxyphenylsilane and triethoxy(phenyl)silane are not irritant to skin. 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 irritation potential that are higher than the typical experimental error of the test method.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals in group 1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable.
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable.
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable.
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable.
Remarks on result:
no indication of irritation
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 trimethoxyphenylsilane CAS 2996 -92 -1. It is concluded that trimethoxyphenylsilane and triethoxy(phenyl)silane are not eye irritating. 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 eye irritation potential that are higher than the typical experimental error of the test method.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No studies were available to assess the skin or eye irritation potential of the test substance, however, data are available for the structural analogue substance trimethoxy(phenyl)silane (CAS: 2996-92-1). 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 trimethoxy(phenyl)silane produces methanol and phenylsilanetriol. Therefore, it is considered that read-across between the substances is appropriate. Neither methanol nor ethanol is an irritant 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.

 

A key skin irritation study, conducted according to OECD TG 404, found trimethox(phenyl)silane was not irritating to rabbit skin. No erythema, oedema, or other dermal effects were noted at any exposure sites (Hazelton Laboratories, 1980a).

A key eye irritation study, conducted according to OECD TG 405, found trimethoxy(phenyl)silane was not irritating to the eyes of rabbit. No corneal opacity, iritis, or conjunctival redness, chemosis, or discharge was noted in the washed or unwashed treated eyes of any of the animals (Hazelton Laboratories, 1980b).

Justification for classification or non-classification

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