Registration Dossier

Administrative data

Description of key information

The key study for skin irritation, conducted according to OECD TG 404, and in compliance with GLP, reports the test material to be not irritating to rabbit skin (LPT, 2002). The key study for eye irritation, conducted according to OECD TG 405, and in compliance with GLP, reports the test material to be not irritating to eyes (LPT, 2002).

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, conducted according to OECD TG 404, and in compliance with GLP, reports the test material to be not irritating to rabbit skin (LPT, 2002).

Following 4-hour dermal application of 0.5 mL of test material onto the skin of 3 rabbits, kept in contact with the skin under semi-occlusive dressing, no erythema or oedema were observed in any of the animals during the 14-day study period. No signs of systemic toxicity were noted in any of the animals.

A supporting skin irritation study was available, conducted according to OECD TG 404, and in compliance with GLP, which also reports the test material to be not irritating to rabbit skin (DCC, 2000).

Following 4-hour dermal application of 0.5 mL of test material onto the skin of 3 female rabbits, kept in contact with the skin under semi-occlusive dressing, well-defined erythema was observed in one animal, which was fully reversible within 10 days. No erythema was observed in the rest of the animals. Oedema was not evident in any of the test animals. No signs of systemic toxicity were noted in any of the animals during the 10-day observation period.

The key study for eye irritation, conducted according to OECD TG 405, and in compliance with GLP, reports the test material to be not irritating to eyes (LPT, 2002).

Following a single instillation of 0.1 mL of test material into the eyes of 3 rabbits, grade 1 corneal opacity was observed in 2 of the animals, which was fully reversible within 48 hours. The iris and conjunctivae were not affected by the test substance. No other signs of systemic toxicity were noted during the observation period.

A supporting eye irritation study was available, conducted according to OECD TG 405, and in compliance with GLP, which also reports the test material to be not irritating to rabbit eyes (DCC, 2000).

Following a single instillation of 0.1 mL of test material into the eyes of 3 rabbits, grade 1 conjunctival redness was observed in all of the animals, which was fully reversible within 48 hours. The cornea and iris were not affected by the test substance. No other signs of systemic toxicity were noted during the observation period.


Justification for classification or non-classification

Based on the available in vivo data for 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane, no classification for skin and eye irritation is required according to Regulation (EC) No. 1272/2008.