Registration Dossier

Administrative data

Description of key information

Studies equivalent to EC methods for assessment of skin and eye irritation were available on analogous substance Distillates (petroleum), straight-run middle (EC: 265-044-7)

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)

Additional information

Skin Irritation

A skin irritation test was conducted using rabbit. The test substance was applied to the intact/abraded skin of 6 rabbits (occlusive; 24 hours). The post-exposure observation period was 14 days. Slight erythema and oedema were seen during 24 -72 hours after exposure with mean scores of 1.8 and 1.5 respectively. Erythema and oedema scores were zero after 7 days and all effects were fully reversible within 14 days. It was concluded that the test substance was slight irritating to skin.

Eye irritation

An eye irritation test was conducted using rabbits. The test substance was instilled in the eye for 20-30 seconds and then washed. The post-exposure observation period was 7 days. No corneal or iridial irritation was seen and there was no initial pain response. It was concluded that the test substance was not irritating to the eye.


Effects on skin irritation/corrosion: slightly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the results obtained for the analogous substance, Distillates (petroleum), straight-run middle (EC: 265-044-7) Renewable Diesel will not fulfil the criteria for classification for these endpoints. Renewable Diesel is expected to be slightly irritating to skin (not sufficient for classification) and not irritating to eyes.