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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 corrosion: not irritating


Eye irritation: not 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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The potential of the test substance to cause skin irritation was tested in an OECD guideline 404 study according to GLP. Three rabbits were treated with 0.5 g moistened test material on a 3 x 3 cm patch to the clipped skin for four hours under occlusive wrap. At the end of the treatment period, the test material was removed and skin reactions were monitored. No mortality, toxicity or clinical signs were observed. No skin reactions were noted at any time point, therefore the study was terminated 72 hours following test substance administration. Based on these findings, the test substance was not irritating to the skin.


 


 


The potential of the test substance to cause eye irritation was tested in an OECD guideline 405 study according to GLP. Three rabbits were treated with 0.1 g unchanged test substance in the conjunctival sac of the left eye, the right eye remained untreated as control. Animals were checked at 1h, 24, 48h and 72h after test substance application for effects on the eyes. Slight conjunctival redness (score 1) was observed at 1h, no effects were recorded at 24, 48 or 72 hours after test substance application. Due to the lack of findings, the study was terminated after 72 hours. Based on these results, the test material was found to be not irritating to the eye.

Justification for classification or non-classification

Based on the data available, the test item does not meet criteria for classification laid down in Regulation (EC) 1272/2008 (CLP).