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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation (Rabbit, GLP, OECD TG 404): not irritating to skin
Eye irritation (Rabbit, GLP, comparable to OECD TG 405): slighltly irritating to the eye
Eye irritation (Rabbit, GLP, comparable to OECD TG 405): not eye irritating
[Schering AG, Report No. 6510, 1985-03-28]

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

The test substance was semiocclusively applied to the intact skin of 2 male and 2 female rabbits for an exposure period of 4 h. Evaluation of skin irritation was made 1 hour after exposure and on days 1 to 4 according to OECD TG 404. Treatment was tolerated without any local reactions to the exposed skin (score 0 for erythema and edema) or other compound-related effects.

In a combined study on acute dermal toxicity and local tolerance a single dermal treatment with 2000 mg test substance for 24 hours under occlusive conditions induced local irritations as skin reddening and scab formation (score 1.7). However, the treatment conditions in this study are of minor relevance for the workplace.

In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight and transient irritation.


Justification for selection of skin irritation / corrosion endpoint:
most relevant study for this endpoint

Justification for selection of eye irritation endpoint:
only one study available

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.