Registration Dossier

Administrative data

Description of key information

The key study for skin irritation found the test material not irritating to the skin of rabbits in a 4 hour occlusive study, conducted according to current OECD guideline and in compliance with GLP (NOTOX 2011).

The key study for eye irritation found the test material not irritating to the eye of rabbits, as determined in a reliable study conducted according to current OECD guieline and in compliance with GLP (NOTOX 2011).

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key study for skin irritation found the test material not irritating to the skin of rabbits in a 4 hour occlusive study, conducted according to current OECD guideline and in compliance with GLP (NOTOX 2011). No erythema or oedema were observed in any of the test animals at any of the scoring intervals (1, 24, 48 and 72 hours) following a 4-hour exposure to the test substance. No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

The key study for eye irritation found the test material not irritating to the eye of rabbits, as determined in a reliable study conducted according to current OECD guieline and in compliance with GLP (NOTOX 2011). Instillation of the test material into one eye of each animal resulted in irritation of the conjunctivae, which consisted of redness and discharge in two animals. The irritation had completely resolved within 24 hours in one animal and within 48 hours in the other animal. The mean Draize score at 1 hour post instillation was 2.7; at 24 hours post instillation it was 0.7 and at 48 and 72 hours post instillation it was 0. No staining of ocular or peri-ocular tissues by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.


Justification for classification or non-classification

Based on the available information, no classification is required for skin or eye irritation of 3,3-bis[(dimethyvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane in accordance with Regulation (EC) No 1272/2008.