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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: not irritating in rabbits
Eye irritation: BCOP: negative; in vivo eye irritation in rabbits: 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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Rabbits is the commonly species used to assess irritation endpoint. It is believed to be more sensitive than humans. Therefore, as the substance was not irritating in rabbits, it should not be irritating to human skin.

For eye irritation endpoint, a BCOP test was performed and showed that the substance has no corrosive or severe irritant effects. Also, an in vivo study in rabbits was performed which enables to classify the substance as irritating according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272 /2008.The substance is considered to be irritating to eyes.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one in vivo study available.

Effects on eye irritation: irritating

Justification for classification or non-classification

The substance induced only moderate skin irritation in rabbits. As overall mean scores for erythema and oedema were lower than 2 and that effects can be considered reversible, the substance should not be classified for skin irritation according to Directive 67/548/EEC and CLP Regulation (EC) N° 1272/2008.

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, mean individual scores at 24, 48 and 72 h post instillation for the 3 animals were 2.0, 2.0, 2.0 for cornea score; 0.0, 1.0, 0.3 for iris score; 1.0, 1.3, 0.7 for conjunctivae score and 1.0, 1.3, 0.7 for chemosis score. All signs of irritation were reversible. Therefore the substance is classified as “R36 Irritating to eyes”, according to Directive 67/548/EEC and "H319 Causes serious eye irritation" according to CLP Regulation (EC) N° 1272 /2008.