Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In GLP guideline studies for skin and eye irritation in rabbits the test item showed no skin or eye irritation properties.

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

Skin irritation

The key study was performed according to OECD guideline 404 in compliance with GLP (BASF AG, 1998). In this study, the potential of the test material to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of 3 white New Zealand rabbits for 4 hours under semiocclusive dressing.

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for erythema and 0.0 for edema. The skin finding observed in 1 animal was reversible 24 hours after removal of the patch. Thus the study was terminated after 72 hours.

Under the test conditions chosen the test material did not give indication of an irritant property to the skin.

Eye irritation

The key study was performed according to OECD guideline 405 in compliance with GLP (BASF AG, 1998). In this study, the potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in 3 white New Zealand rabbits subjected to a single ocular application of 0.1 mL bulk volume (about 27 mg) of the test substance on day 0 (BASF AG, 1998).

The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis, and 0.4 for conjunctivae redness. The findings were reversible in all animals within 72 hours after application. Thus the study was terminated. The observed symptoms do not indicate an irritant property of the test substance to the eye.

Under the test conditions chosen the test substance did not give indication of an irritant property to the eye.


Justification for selection of skin irritation / corrosion endpoint:
only available reliable study

Justification for selection of eye irritation endpoint:
only available reliable study

Justification for classification or non-classification

Based on the results of the skin and eye irritation studies the test item does not need to be subjected to classification and labelling according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP/GHS).