Registration Dossier

Administrative data

Description of key information

Skin irritation -

The skin irritation potential was identified in a literature paper which is off accepted scientific standard (Motoyoshi K et al 1979), however was not sufficient for C& L. The paper looked at the skin irritancy potential of the read-across substance phenethyl alcohol in Guinea pigs, rabbits, miniature swine and humans.

Eye irritation:

The eye irritation potential  was identified in a key study conducted to OECD Guideline 405 (Acute Eye Irritation / Corrosion) on the read-across substance phenylacetic acid.

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:
adverse effect observed (irritating)

Additional information

Skin Irritation:

Test on Guinea pigs and rabbits on the read-acoss subtance Phenylethyl alcohol led to the conclusion that the substance is a moderate irritant, however the test on miniature swine did not show any irritant effects. This is not sufficient for C & L purposes as the total score was the average of the reddening rate ( erythema, 72 h reading), the dilating rate, the swelling rate, and the bluing rate of 6 animals in a group. Only two parameters out of these can be used for C & L purposes therefore the subtance cannot be classified as a moderate irritant.

A patch test on a panel of 50 male adults on the read-acoss subtance Phenylethyl alcohol (in 32% actone) was found to be negative for skin irritation. Since no skin irritation effect were seen in miniature swine and in particular the humans patch test the substance Phenylethyl alcohol was concluded as not an skin irritant overall.

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Eye Irritation:

The eye irritation study conducted to OECD Guideline 405 (Acute Eye Irritation / Corrosion) on the read-across substance phenylacetic acid has been concluded as a GHS category 1 eye irritation. It was found that in at least 2 animal's effects on the cornea were not fully reversed fully within an observation period of 21 days, thus leading to the justification of the GHS categoty 1 classification.