Registration Dossier

Administrative data

Description of key information

GLP guideline study showing very slight erythema to rabbit skin (OECD 404)  
Non-GLP study reporting increased irritation response over 7 days after 24 hour exposure to the test substance

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Dermal Irritation

Longer exposure to the test material in the non-GLP study produced higher scores for erythema and oedema and showed an increasing effect over the first 7 days after exposure. However, no effect was attributed to abrasion of skin and the effects were largely reversible within 14 days. A recent GLP study conducted in accordance with the recognised guideline reported very mild irritation, which was fully reversible within 7 days.

Eye Irritation

A recent GLP study conducted in accordance with the recognised guideline reported conjunctival irritation that resolved within 72 hours. The results confirmed those reported in a previous non-GLP study.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

SKIN IRRITATION

Results from a modern GLP guideline study did not indicate significant inflammation of the skin under the terms of Directive 67/548/EEC or Regulation (EC) 1272/2008. No classification is therefore warranted under GHS/CLP.

EYE IRRITATION

Results from a modern GLP guideline study did not indicate significant eye inflammation under the terms of Directive 67/548/EEC or Regulation (EC) 1272/2008. No classification is therefore warranted under GHS/CLP.