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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

For skin irritation/corrosion, no adverse effects were observed in two in-vitro studies.
Adverse effects were observed in an in-vivo acute dermal toxicity study.
For Eye irritation, an adverse effect was observed in the BCOP in-vitro test.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Using the weight of evidence approach for skin irritation/corrosion it is concluded, that the substance has skin irritating properties:

1.) The available in-vitro skin irritation/corrosion studies indicate no adverse effects.

2.) For the in-vivo acute dermal toxicity study local effects are observed. These effects are erythema which are fully reversible within 7 days and scaling.

3.) The in-vitro Eye corrosion study shows adverse effects on the eye, the substance is characterised as severe irritating for the eye.

Taking together arguments 2.) and 3.), the substance may be irritant or corrosive to the skin.

The described observation from argument 2.) indicate only irritant properties.

Therefore the irritant/corrosive properties of the substance with regard to the skin can be described as "irritating".

The eye corrosion property of the substance is studied using the BCOP in-vitro test. A valid result is obtained showing corrosive properties. Further testing is not needed.

Justification for selection of skin irritation / corrosion endpoint:
From the available Endpoints non is choosen as the performed in-vitro studies indicate no effects. Justification for the Endpoint conclusion is based on local adverse effects observed in an in-vivo acute dermal toxicity study and adverse effects in an in-vitro eye irritation/corrosion study (see Discussion) .

Justification for selection of eye irritation endpoint:
only one valid in-vitro study available.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification