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Administrative data

Description of key information

skin irritation, rabbits (m/f), intact skin, not irritating
eye irritation, rabbits (m/f), washed and unwashed eye, not 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)

Additional information

One study was performed to assess the skin irritation potential of the analogue test item (Huntsman 1980). Males and females of NZW rabbits were exposed to the test item and the mean values for edema and erythema over 24,48 and 72h observation period were recorded. Under the experimental conditions the test item is not considered as a skin irritant.

One study was performed to assess the eye irritation potentail of the analogue test item (Huntsman, 1980).

Males and females of NZW rabbits were exposed to the test item and the mean values for cornea, iris and conjunctivae over 24,48 and 72h observation period were recorded. Under the experimental conditions the test item is not considered as an eye irritant.

Based on the read across considerations the same results apply to Acid Black 164.

Justification for classification or non-classification

Under Regulation 1272/2008 a substance is classified as skin irritant Cat. 2 if:

1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Mean values at 24, 48 and 72h for oedema or erythema are <2 for all animals and are completely reversible within 72h, therefore the test substance is not classified as skin irritant.

Under Regulation 1272/2008 a substance is classified as eye irritant Cat. 2 if it is present at least in 2 of 3 tested animals, a positive response of: 1)    corneal opacity ≥ 1 and/or 2)   iritis ≥ 1, and/or 3)  conjunctival redness ≥ 2 and/or 4)  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.

All the scores calculated as mean value at 24, 48 and 72h for the test substances for all tested animals are equal to zero, therefore the substance is not classified as eye irritant.

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