Registration Dossier

Administrative data

Description of key information

The key skin sensitisation study, conducted according to OECD TG 406, and in compliance with GLP, reports the test substance, 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane, to be not sensitising (DCC, 2000).

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The key skin sensitisation study, conducted according to OECD TG 406, and in compliance with GLP, reports the test substance, 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane, to be not sensitising (DCC, 2000).

At induction, 3 intradermal injections of Freund's Complete Adjuvant diluted in water, 1% (v/v) of test material in Alembicol D, or 1% (v/v) test material in a 50:50 mixture of Freund's Complete Adjuvant and Alembicol D, were made intracutaneously to the scapular region of 20 test guinea pigs (day 1). One week later, 0.4 mL of undiluted test substance was applied epicutaneously to the same area for 48 hours, kept in contact with the skin under impermeable plastic adhesive tape.

At challenge (two weeks after topical induction application), 0.2 mL of 25% and 50% test material in Alembicol D were applied topically to the left flank of each test animal, kept in contact with the skin for 24 hours under impermeable dressing. Dermal reactions were evaluated at 24 and 48 hours after removal of the test material. Changes in body weight were recorded on day 1 and the last day of the observation period. At the end of the study period, all the animals were sacrificed and necropsy was performed.

No mortality occurred during the observation period. Expected body weight gain was observed in all the animals. No dermal reactions (erythema or oedema) were noted in any of the test animals at 24 and 48 hours after challenge exposure.

Appropriate negative and positive controls were used and gave expected results.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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 is required for skin sensitisation according to Regulation (EC) 1272/2008.