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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye: Based on the results of the only available (and reliable) study (in vivo), the test substance is considered as not irritating to the eye.
Skin: As the test substance did not induce any skin irritation effects in both an acute dermal toxicity study (dose of 2000 mg/kg bw) and a LLNA assay (at the max. test concentration), it can be concluded that the test substance is not skin irritating.

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 eye irritation potential of the test substance was investigated in a study according to OECD test guideline 405.

The amount of 0.1g was applied to eyes of three Russian rabbits and washed out after 1 hour. After 1 hour, redness (score 1) was observed in all rabbits and chemosis of score 1 in one rabbit. No irritant reaction was present after 24, 48 and 72 hours in all rabbits. Therefore, the test substance is considered to be not irritating to the eye.

As the test substance did not induce any skin irritation effects in both a acute dermal toxicity study (dose of 2000 mg/kg bw) and a LLNA-test (max. test concentration of 50%, application volume 25µl), it can be concluded that the test substance is not skin irritating. Therefore, there is no need to further investigate the skin irritation potential.

Justification for classification or non-classification

Eye irritation:

The test substance did not induce any effects after 24, 48 and 72 hours and does therefore not need to be classified.

Skin irritation:

The test substance did not induce skin irritation effects in an acute dermal limit test and in a LLNA for skin sensitisation.

Therefore, it does not need to be classified.