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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritant

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

The skin and eye irritation potential of the substance was evaluated by taking into consideration available data on Similar Substance 02. Justification for Read Across is given in section 13 of IUCLID.

Skin Irritation

In the GLP compliant study, the skin irritancy potential of Similar Substance 02 was assessed in vivo using a method based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-5 “Primary dermal irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978. Six New Zealand White rabbits were exposed to the test material in an occlusive fashion for 24 hours on both intact and abraded skin. The skin reactions were evaluated in accordance with the Draize scale at 24, 48 and 72 hours followed by observations after 4 and 7 days.

Under the conditions of this study, the test material was found to be a skin irritant.

 

Eye Irritation

In the GLP compliant key study, the eye irritancy potential of the analogue substance was assessed in vivo using a method based upon the procedure outlined in the guidelines of the United States EPA, Paragraph 163.81-4 “Primary eye irritation study”, Federal Register, Vol. 43 No. 163, August 22, 1978. Nine New Zealand White rabbits were exposed to the test material; the treated eye of three animals was rinsed with saline 30 seconds after exposure. while the rest of the eyes remained unwashed. The reactions to the test material were evaluated in accordance with the Draize scale after 24, 48 and 72 hours followed by further observations after 4 and 7 days. Based on the irritation scores obtained, the substance is considered to be an eye irritant. The irritation scores seemed to decrease after 7 days but they were not reversible at the end of the observation period.

Justification for classification or non-classification

According to the CLP Regulation (EC) No.1272/2008, a substance is classified in Category 2 for Skin irritation when the mean score for erythema/eschar or for oedema is found between 2.3 - 4.0 in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal. All animals presented a mean score of erythema more than 3 and 5 out of 6 animals presented a mean score of 5 for edema. The substance is classified as a Skin Irrit.2 (H315).

According to the CLP Regulation (EC) No.1272/2008, a substance is classified in Category 2 for Eye irritation when it produces in at least in 2 of 3 tested animals, a positive response of: (a) corneal opacity ≥ 1 and/or (b) iritis ≥ 1, and/or (c) conjunctival redness ≥ 2 and/or (d) conjunctival oedema (chemosis) ≥ 2 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days. The substance produced conjuctivae and chemosis scores higher or equal to 2 in all tested animals. The substance is classified as an Eye Irritant 2 (H319).