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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Two studies in rabbits were performed to evaluate irritating or corrosive properties of the test material to skin or

eyes (OECD guideline 404 and 405). Application of the test substance did not provoke skin irritation. Treatment of rabbits eyes caused slight conjuctival irritation. All reaction resolved within 7 days and were below the treshold of regualtion. Therefore, the substance is not considered to be 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 item to cause acute dermal irritation or corrosion was assessed by a single topical application of an amount of 0.5 g of the test item for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch. The following test item-related clinical observation was recorded immediately after removal of the patch in one animal only: very slight erythema (grade 1). The cutaneous reaction was reversible in this animal within 1 hour after removal of the patch. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema. Considering the described cutaneous reaction as well as the average score for irritation, the test item does not show a skin irritating potential under the test conditions chosen.

The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 16 mg) of the test item to one eye of three White New Zealand rabbits. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, 72 and 96 hours after application and on study day 7. The following test item-related clinical observations were recorded during the course of the study: slight conjunctival redness (grade 1), slight discharge (grade 1). Additional findings like injected scleral vessels in a circumscribed area were noted at hour 1 or from hour 1 until hour 24 in all animals. The ocular reactions were reversible in all animals within 7 days after application at the latest. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 1.0, 0.3 and 0.3 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis. Considering the described ocular reactions as well as the average score for irritation, the test substance does not show an eye irritating potential under the test conditions chosen.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified as irritating for skin or eyes under Directive 67/548/EEC.

                                             

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008.