Black HM 2482

Endpoint summary

Description of key information

Skin Irritation: Non irritating
Eye Irritation: Non 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

SKIN IRRITATION
The skin irritation potential of the substance was evaluated in an in vivo experimental study according to the OECD Guideline 404. 0n test day 1, 0.5 g of the test article was applied to the intact skin of the shaved area and the skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removing of the dressing, gauze patch and test article.
Under the conditions of this experiment, test item was found to cause a primary irritation score of 0 when applied to intact rabbit skin. In the area of application a severe black discoloration of the skin was observed which could be related to effects of the test article. No corrosion effect had occurred on the skin at each measuring interval.

 

EYE IRRITATION
The substance was tested for eye irritation according to the OECD Guideline 405 (1981). A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 g per animal. The eyes of each animal were examined 1, 24, 48 and 72 hours after administration. Under the conditions of this esperiment, test item was found to cause a primary irritation score of 0.6 when applied to the rabbit eye mucosa. In the area of application a severe black discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. No corrosion was observed at each of the measuring intervals.

Justification for classification or non-classification

Skin Irritation / Corossion
A corrosive substance is a substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to 4 hour duration.
To classify a substance as irritant, the major criterion is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 - ≤ 4,0.
The mean score of observed values of erythema & edema after 24, 48, 72 hours after patch removal for all the three rabbits is 0.
The substance is not classified as skin irritant because in the performed tests it doesn't meet the classification criteria of the CLP regulation (EC) No. 1272/2008.

 

Eye Irritation
According to the CLP Regulation (EC 1272/2008), serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance, which is not fully reversible within 21 days of application. Eye irritation means the production of changes in the eye, which are fully reversible within 21 days of application.
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and chemosis, in all the tested animals. 

In conclusion, the substance does not meet the criteria to be classified for the eye/skin irritation, according to the CLP Regulation (EC) No 1272/2008.