Dimethoxydiphenylsilane

Endpoint summary

Description of key information

Skin irritation in rabbits (OECD TG 404, GLP): irritating
Eye irritation in rabbits (OECD TG 405, GLP): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Two studies on skin and eye irritation are available for assessment of the irritative/corrosive properties of dimethoxydiphenylsilane.

Skin irritation/corrosion:

In the key study for the assessment of skin irritation 3 New Zealand White rabbits were treated with 0.5 ml of the test substance for 4 h under semi-occlusive conditions with subsequent washing (Hüls AG, 1995b). The study was performed according to OECD TG 404 and in compliance with GLP regulations. In all three animals grade 2 erythema and grade 4 edema (2/3 animals) were observed by 30-60 minutes after patch removal. The mean scores over 24, 48, and 72 h were 2 for erythema reactions in 3/3 animals, and 3, 2, and 3.3 for edema scores in animal 1, 2, and 3, respectively. Dry skin and desquamation were observed in all animals after approximately one week. All effects were fully reversible within 13 days.

In a second study 3 females New Zealand White rabbits were treated with 0.5 ml of the test substance for 4 h under semi-occlusive conditions with subsequent washing with water (Bayer AG, 1984a). The study was performed according to OECD TG 404 and not in compliance with GLP regulations. No effects were observed, thus the mean scores over 24, 48, and 72 h were 0 for erythema and edema in all animals.

 

Eye irritation:

In the key study for the assessment of eye irritation 3 New Zealand White rabbits were treated with 0.1 ml of the test substance for 24 h with subsequent washing (Hüls AG, 1995c). The study was performed according OECD TG 405 and in compliance with GLP regulations. Grade 2 conjunctival redness was observed in all three rabbits one hour after treatment. Grade 1 conjunctival chemosis was observed at one hour and 24 hours in all three animals. There was no sign of irritation in any of the animals by 48 hours. There were no signs of irritation in the corneal or iris throughout the whole study period. The mean scores over 24, 48, and 72 h were 0.33 for redness and chemosis in each animal. In conclusion, dimethoxydiphenylsilane is considered to be not irritating to the eye.

These findings were supported by a second study, where also 3 New Zealand White rabbits were treated with 0.1 ml of the test substance for 24 h with subsequent washing (Bayer AG, 1984b). The study was performed according to OECD TG 405 but not in compliance with GLP regulations. None of the animals showed any signs of irritation, which supports the findings of the key study, that dimethoxydiphenylsilane is considered not to be irritating to the eye.

Justification for classification or non-classification

The available data on skin irritation of the test substance meet the criteria for classification as “skin irritant, cat. 2” (H315) according to Regulation (EC) 1272/2008 and as “Xi: irritant” (R38) according to Directive 67/548/EEC.

The available data on “eye irritation” of the test substance 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.