Dimethoxymethylsilane

Endpoint summary

Description of key information

Skin irritation: not irritating (OECD TG 404, RA from CAS 2031-62-1)
Eye irritation: not irritating (OECD TG 405, RA from CAS 2031-62-1)

 

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 read-across justification.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

No irritation potential was observed with the source substance, thus no irriation potential is estimated for the target substance. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in skin irritation potential.

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 read-across justification.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

over all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

over all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of animals #1 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

over all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Animal No. 1 and 3 showed redness grade 1 of the conjunctivae 1 hour post instillation. 24 hours post instillation until the end of the observation period no signs of irritation were recorded.
Animal No. 2 showed redness grade 1 of the conjunctivae 1 hour, as well as 24 hours post instillation. 48 hours, as well as 72 hours post instillation no signs of irritation were recorded.

Other effects:

Throughout the observation period not weight loss was observed for the test animals.

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

In conclusion, it was shown that the source substance is not irritating to the eyes. This is also estimated for the target substance. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in eye irritation potential.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No measured irritation data are available for the registered substance dimethoxy(methyl)silane (CAS 16881-77-9), however, data are available for the structural analogue diethoxy(methyl)silane (CAS 2031-62-1). Both substances hydrolyse in contact with water to produce the common silanol hydrolysis products, methylsilanediol and methylsilanetriol. Therefore, it is considered that read-across between the substances is appropriate.

 

In the key skin irritation study performed according to OECD TG 404 and in compliance with GLP (BSL, 2007), three female New Zealand White rabbits were exposed to 0.5 mL of the neat test material (CAS 2031-62-1) for 4 hours applied onto the clipped skin via semi-occlusive dressing. Skin reactions were evaluated 1, 24, 48 and 72 hours post-application. Neither erythema nor edema formation were observed during the study period. There were no remarkable body weight changes during the contact and observation period.

Based on the above study result on the source substance diethoxy(methyl)silane (CAS 2031-62-1) and according to EU classification criteria, dimethoxy(methyl)silane (CAS 16881-77-9) is considered to be not irritating to the skin.

 

In the key eye irritation study performed according to OECD TG 405 and in compliance with GLP (BSL, 2007), 0.1 mL of diethoxy(methyl)silane (CAS 2031-62-1) was instilled in the eye of three female New Zealand White rabbits. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours post-application. All animals showed redness (grade 1) of the conjunctivae 1 hour post-application which was fully reversible within 48 hours post-application. No further signs of irritation and no remarkable body weight changes were noted during the study period.

Based on the above study result on the source substance diethoxy(methyl)silane (CAS 2031-62-1) and according to EU classification criteria, dimethoxy(methyl)silane (CAS 16881-77-9) is considered to be not irritating to the eyes.

Justification for classification or non-classification

The available data on skin and eye irritation for the structural analogue substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.