Reaction products of diazotised 4'-aminoazobenzene-4-sulphonic acid, coupled with resorcinol and diazotised sodium 4-aminobenzenesulfonate, sodium salts

Endpoint summary

Description of key information

not skin irritant

not eye irritant

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/CORROSION

The acute dermal irritation potential of the test item was evaluated in an in vivo study according to the OECD Guideline 404 (1981). 0.5 g of test item was applied on the clipped skin of six rabbits using a semi-occlusive patch; the right flank untreated was used as control.

No cutaneous reaction was observed. The erythema and oedema scores (mean values 24/48/72 h) were 0 in all animals.

 

EYE IRRITATION/CORROSION

The acute eye irritation potential of test item was evaluated in an in vivo study according to the OECD Guideline N 405 (1981). 0.5 g of test item was applied into the left eye of six rabbits; the right eye untreated was used as control. The eye observations were performed without rinsing the treated eye during a study period of 8 days after the test item application.

Corneal opacity and iritis scores (mean values 24/48/72 h) were 0 in all animals. Conjunctival redness scores (mean values 24/48/72 h) were<2 in all animals;conjunctival oedema (chemosis) scores (mean values 24/48/72 h) were < 2 in all animals expect for one animal (2 in animal #6). All effects observed were fully reversible within the observation period.

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible damage to the skin following the application of a test substance for up to 4 hours are classified in Category 2 (irritating to the skin) if:

-mean value of ≥ 2.3 ≤ 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from readings at 24, 48 and 72 h after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

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

-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.

Based on the available experimental data of skin irritation, the mean scores (24/48/72h) of erythema and edema were not in the range of ≥ 2.3 - ≤ 4.0; therefore the substance is not classified for skin irritation according to the CLP Regulation (EC 1272/2008).

 

EYE IRRITATION

According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) if, when applied to the eye of an animal, a substance produces at least in 2 of 3 tested animals, a positive response of:

-corneal opacity ≥ 1 and/or

-iritis ≥ 1, and/or

-conjunctival redness ≥ 2 and/or

-conjunctival oedema (chemosis) ≥ 2,

calculated as the mean scores following grading at 24, 48 and 72 h after installation of the test material, and which fully reverses within an observation period of 21 d.

Based on the available experimental data of eye irritation, the mean scores (24/48/72h) of corneal opacity and iritis were not ≥ 1 and conjunctival redness and conjunctival oedema (chemosis) were not ≥ 2. Moreover, all effects observed were fully reversible within the 14 day-study period. Therefore, the substance is not classified for eye irritation according to the CLP Regulation (EC 1272/2008).