Registration Dossier

Administrative data

Description of key information

GLP study reporting the substance to be non-irritating to rabbit skin (OECD 404). 
Non-GLP study reporting moderately irritating to rabbit skin after 24 h exposure under an occlusive dressing
GLP study reporting initial irritation to rabbit eyes which had cleared by 7 d (OECD 405)
Non-GLP study reporting the test substance to be a mild irritant to rabbit eyes

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

SKIN IRRITATION

A non-GLP study found a single application of the test material to occluded rabbit skin was moderately irritating after an exposure period of 24 h. However, a modern GLP study reported minimal erythema at 24 h progressing to moderate inflammation by 72 h post dosing where all effects had cleared within 14 days. The levels and/or sustainability of irritation were not sufficient for classification (CLP/DSD).

EYE IRRITATION

A non-GLP study considered the test material to be mildly irritating to rabbit eyes. However, a more modern GLP study reported no initial pain response and found moderate conjunctival redness in all six rabbits and minimal corneal opacity in three rabbits had completely cleared by 7 days. The results did not warrant classification for eye irritation (CLP/DSD).

Justification for classification or non-classification

SKIN IRRITATION

 

Study results do not lead to classification as a skin irritant under the terms of Directive 67/548/EEC or Regulation (EC) 1272/2008.

EYE IRRITATION

Study results do not lead to classification as an eye irritant under the terms of Directive 67/548/EEC or Regulation(EC) 1272/2008.