Registration Dossier

Administrative data

Description of key information

This substance is not irritating to skin or eyes. 

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 irritation (comparable to OECD TG 404)

In a key study this substance was applied to an abraded and an intact site on each white rabbits under semi-occlusive dressing for 24 hours (Costello, 1982). Six animals were tested in the study. Evaluation was made on the arithmetic mean of all animals. The primary irritation was determined to be 0.84. According to the conclusion of the study, the substance is not irritating to skin.

Eye irritation (similar to OECD TG 405)

In a key study, 0.1 mL test substance was instilled into the conjunctival sac of white rabbits (Costello, 1982). The test material was not washed from the eyes.The eyes were examined and graded for ocular reaction at 1h, and 1, 2, 3, 4, 7 days following instillation of test material into the eyes. The overall primary ocular irritation index was 0.7 and the test substance was unlikely to be an ocular irritant in the test animals.

Justification for classification or non-classification

Skin irritation

Since 6 animals were tested, the evaluation of test results was performed according to the Example 3b (section 3.2.6.1.4. in the ECHA "Guidance on the Application of the CLP Criteria", 2009). According to this approach the average score is determined per animal. In this case, if 4 of 6 animals reached a cut-off value of 2.3 or above at 24, 48 and 72 hours after patch removal, the classification as Skin Irritant is assigned. The highest mean value for erythema/eschar and for oedema was 1.0 in animal No.3. The mean values for other animals were all lower than 1.0. Therefore, this substance does not meet the requirement under EU CLP (Regulation (EC) No. 1272/2008) for classification as a skin irritant.

Eye irritation

In case of 6 rabbits, classification as eye irritant triggers if at least 4 ot 6 rabbits show a mean score of ≥ 1 for the cornea and/or for iris and ≥ 2 for conjunctival erythema and/or conjunctival swelling. In the eye irritation study, the mean score of 0.0 was for cornea and for iris in all animals grading at 24, 48 and 72 hours after instillation. The mean score of 0.33 was for conjunctival erythema and for conjunctival swelling only in one animal. Thefore, the substance does not meet classification criteria under EU CLP (Regulation (EC) No. 1272/2008) as eye irritant.