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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Not irritating, male rabbit; OECD 404; Janssen and van Doorn, 1992a
EYE
Not irritating, male rabbit; OECD 405; Janssen and van Doorn, 1992b

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)

Additional information

Skin

In the key study, three rabbits received a single four hour application of 0.5g of the test material and were assessed for at 30 minutes, 24, 48 and 72 hours after treatment for any signs of skin irritation. Very slight erythema was seen in all animals 30 minutes after removal of test material and very slight erythema was seen in one animal after 24 hours. There were no other signs of skin irritation. The study was performed in line with GLP, to a standardised guideline and with a high standard and as such was assigned a reliability score of 1.

Supporting information is available in the form of a study in which the test material was applied to abraded and non abraded skin of three rabbits for five consecutive days. Readings of the reactions were made every 24 hours up to 10 days after first application. Under the conditions of the study, the test material did not elicit any reaction in any of the animals. The study was not performed to GLP but was conducted in line with solid scientific principles and as such was assigned a reliability score of 2.

Eye

In the key study, 0.1 ml of test material was placed into the conjunctival sac of one eye of each of three male rabbits. The eyes of the rabbits were examined and the ocular reactions graded at 24 hour intervals up to and including 72 hours post treatment. At 24 hours after application of the test material a fold of the cornea across the whole eye was observed in one rabbit. No adverse effects were observed hereafter. The study was performed in line with GLP, to a standardised guideline and with a high standard and as such was assigned a reliability score of 1.

Supporting information is available in the form of a study in which the test material was placed into the conjunctival sac of eight male rabbits. The treated eye of five animals were rinsed with 300 ml of lukewarm water 5 minutes after installation of the test material. The treated eyes of the remaining three animals were rinsed in the same way 24 hours after installation. Readings of reaction of all animals were made at 1, 24, 48, 72 and 96 hours and at 7 days after installation of the test material. At 1 hour after application of the test material a slight redness of the conjunctivae was apparent in all animals of both groups; no adverse effects were observed hereafter. The study was not performed to GLP but was conducted in line withsolidscientific principles and as such was assigned a reliability score of 2.

Overall, the results of not irritating were consistent over all studies and considered suitable for assessment as an accurate reflection of the test material. The available data is considered to be complete and the conclusion for both skin irritation and corrosion, and eye irritation, not irritating, was taken forward for risk assessment.

Justification for classification or non-classification

Under the conditions of the studies, the test material is considered to be practically non-irritating to the skin and eye and does not require classification for skin irritation in line with Regulation No. 1272/2008.