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Administrative data

Description of key information

Skin Irritation
Key, Cognis, Steiling, 1991, rabbit, skin irritation, RL2 – not irritating
Eye Irritation
Key, Cognis, Steiling, 1991, rabbit, eye irritation, RL1 – not irritating

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

The irritating potential of the Fatty Acid Polyol with CAS No. 85116-93-4 (C16-18, esters with pentaerythritol) was tested in studies conducted according to OECD Guideline 404 (skin irritation/corrosion) and OECD Guideline 405 (eye irritation).

 

Skin Irritation

C16-18, esters with pentaerythritol (CAS No. 85116-93-4) was tested for its skin irritation potential according to OECD Guideline 404 (Key, Cognis, Steiling, 1991, rabbit, skin irritation, RL2): The shaved back of three Kleinrussen, Chbb:HM rabbits was exposed to 0.5 g test material for 4 hours under semi-occlusive conditions. Thereafter, the rabbits were observed for 72 hours. Skin reactions were assessed using the Draize scheme 24, 48 and 72 hours after removal of the test substance. No erythema and no oedema occurred in any of the tested animals at any reading time point.

 

Eye Irritation

C16-18, esters with pentaerythritol (CAS No. 85116-93-4) was tested for its eye irritation potential according to OECD Guideline 405 (Key, Cognis, Steiling, 1991, rabbit, eye irritation, RL1).

0.1 mL of the test material was instilled into the conjunctival sac of one eye of three Kleinrussen, Chbb:HM rabbits. The animals were observed for 72 hours. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize. No eye irritation was observed in any tested animal at any observation time point except for a slight and reversible exsudation after 24 h in one animal.

Justification for classification or non-classification

According to the DSD and CLP criteria for classification and labelling of dangerous substances C16-18, esters with pentaerythritol (CAS No. 85116-93-4) is not classified as skin or eye irritant.