Registration Dossier

Administrative data

Description of key information

Skin irritation (OCED TG 404): irritating 
Eye irritation (OECD TG 405): 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

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

A key skin irritation study which was conducted according to OECD TG 404 and GLP, showed that (3-chloropropyl)diethoxymethylsilane was irritating to the skin of small white Russian rabbits. 30-60 minutes after removal of the dressing’s two rabbits had grade 2 erythema and edema, and one had grade 1 erythema and edema. After 24 and 48 hours the irritation had worsened so that the erythma was grade 2 and 3 and the edema was grade 2 and 4. The irritation then gradually reversed until there were no signs of erythema and edema on day 10. Yellow skin discolouration in animal 1 after 24 and 48 hours was observed. Dry or flaky skin in all animals after about a week was also observed. It was therefore concluded that (3-chloropropyl)diethoxymethylsilane was irritating to rabbit skin (Hüls AG, 1997c).

 

A key eye irritation study which was conducted to OECD TG 405 and GLP, showed that (3-chloropropyl)diethoxymethylsilane was only very slightly irritating to the eyes of small white Russian rabbits and therefore was not classified as an eye irritant. Within one hour of instillation there was some redness and edema of the conjunctiva. By 24 and 48 hours after instillation there was some redness, but no edema. At 72 hours there were no signs of irritation remaining. It was therefore concluded that (3-chloropropyl)diethoxymethylsilane was not an eye irritant (Hüls AG, 1997d).


Justification for selection of skin irritation / corrosion endpoint:
The key study was selected for assessment.

Justification for selection of eye irritation endpoint:
The key study was selected for assessment.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the available study for skin irritation, (3-chloropropyl)diethoxymethylsilane needs to be classified as R38 ‘’irritating to skin’’ according to the criteria of EU Directive 67/548/EEC, and Skin Irritant Category 2 under Regulation 1272/2008.

The available data on eye irritation of the registered 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.