Registration Dossier

Administrative data

Description of key information

The registration item will be considered as irritating to the skin and non-irritating to the eyes.

 

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

Skin irritation / corrosion

3,5,5-trimethylhexyl acetate is considered to be irritating to skin. In a similar to OECD TG 404 study in rabbits the mean values of erythema score at 24, 48 and 72 hours were between 2.3 and 3.7 in all tested animals (Unilever Research Laboratory 1982).

Eye irritation / corrosion

Two in vivo studies on eye irritation are available. In one of the studies, eight rabbits were treated with the test article (0.1 mL) diluted to 50% in olive oil. The eyes of 4 rabbits were rinsed immediately after dosing; the other 4 rabbits were left without rinsing. No mucosal reactions in the area of the eyes or the mucosa of the eye were noted. The spontaneous defence actions were insignificant.

In the second study, three rabbits were treated with 100 µL of a 10% dilution in Tween 80, one rabbit was treated with 100 µL of a 50% dilution in Tween 80 and one rabbit was treated with 100 µL undiluted substance. The grading of the ocular lesions was equivalent to the grading suggested in OECD TG 405. The mean of the cornea, iris and chemosis scores at 24, 48 and 72 h was below 1 in all animals and the mean of the conjunctivae scores at 24, 48 and 72 h was below or equal to 1 in all animals.

Thus, the available data set has certain limitations with regard to study quality and description. As all studies revealed low irritation potential and in order to respect the animal testing ban for cosmetics, it is still proposed to waive further in vivo testing and to conduct the hazard assessment on the basis of the available data.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

Skin irritation / corrosion

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin irritation/corrosion, the test item is classified and labelled as skin irritant category 2 (H315: "Causes skin irritation") according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighth time in Regulation (EU) No 2016/918.

Eye irritation / corrosion

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available weight of evidence data on eye irritation/corrosion, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighth time in Regulation (EU) No 2016/918.