Registration Dossier

Administrative data

Description of key information

A standard skin irritation study was not conducted; however, a dermal toxicity study was conducted in rats (OECD 402) and no irritation was observed.  An eye irritation test in rabbits (OECD 405, OPPTS 870.2400; and EEC Method B.5) was conducted with TMBPA to assess irritation/corrosion effects.  Under the test conditions and according to GHS Classification, TMBPA was considered not irritating to eyes.  
Based on the lack of corrosive effects reported in acute dermal toxicity and eye irritation studies on animals, TMBPA is not a corrosive substance.

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)

Additional information

In the GLP/OECD guideline 402 dermal toxicity study, rats were dermally exposed to TMBPA moistened with water (70% w/w mixture; dosed at 2000 mg TMBPA/kg body weight) for 24 hours. After exposure, the occlusive dressings were removed and the animals were observed for 14 days. No signs of dermal irritation were noted on any animal at any time post-exposure. In the GLP/OECD guideline 405 eye irritation study, no corneal or iris involvement was observed in the test eyes of any animal at any time point. Only slight conjunctival redness, slight to obvious chemosis with slight to moderate discharge were observed in all three animals at 1 hour. By 24 hours, only slight conjunctival redness and discharge were noted in one animal. All animals showed no signs of ocular irritation, redness or discharge at 48 and 72-hours. Therefore, under the conditions of this study and according to GHS Classification, TMBPA is considered to be not irritating to the eye.

Justification for classification or non-classification

Based on the lack of corrosive effects in an acute dermal toxicity study and the negative results in an eye irritation study, the test substance does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.