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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The substance is non-irritant to skin and eye of rabbits.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Local changes induced by the substance at the site of contact, namely skin and eye, were evaluated irrespective of whether the substance may become systemically available. Skin and eye irritation of the substance was tested on rabbits by topical application and instillation, respectively. As for the dermal application, pink staining of the treated skin was seen during the whole observation period. As for the eye instillation, no effects on cornea and iris and signs of conjuctivae chemosis were seen. The conjuctivae redness was observed in female rabbits, but the relative scores were below the threshold for classification of the substance as irritant.

The dermal exposure to the substance induced no systemic symptoms in animals during the test and observation period, and no mortality. One female lost weight during the acclimatisation period, while the body weight gain of other animals was not affected during the study period.

Similarly, in the case of eye, no clinical signs of systemic toxicity were seen and no mortality occurred. The body weight of the animal was within the normal range of variability.

Under the test conditions, during the observation period, the substance did not induce systemic toxicity.

 


Justification for selection of skin irritation / corrosion endpoint:
The study is reliable and representative.

Justification for selection of eye irritation endpoint:
The study is reliable and representative.

Justification for classification or non-classification

The substance is not classified according to the CLP Regulation (EC 1272/2008). As for skin irritation, the mean scores for erythema and edema at 24, 48 and 72 hours are lower than threshold level of 2.3 for at least 2 of 3 animals.

As for eye irritation, the averaged scores at 24, 48 and 72 hours for at least 2 of 3 animals are lower than the threshold level of 1 for cornea and iris, and lower than threshold level of 2 for conjuctivae redness and chemosis.