Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.