reaction product of: C.I. Leuco Sulfur Black 1 with (3-chloro-2-hydroxypropyl)trimethylammonium chloride

Endpoint summary

Description of key information

Not Skin Irritant / Skin Corrosive

Category 1 (Serious Eye Damage)

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:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation / Corrosion

Skin irritation potential was evaluated in an experimental study according to the OECD Guideline 404 (1992) and EU method B.4 (1992). 0.5 g of undiluted, solid test item was applied to the shaved, dorsal area of three rabbits for a duration of 4 hours. Observations were recorded at 1, 24, 48 and 72 hours after removal of test substance. Irritation scores (mean 24, 48 and 72 hours) were 0.0 for both erythema and oedema in all test subjects. In the area of application, pale black staining of the treated skin was observed in all test subjects. No corrosive effect was observed. The test substance is not corrosive or irritating to the skin.

Eye Irritation / Corrosion

Eye irritation potential was evaluated in an experimental study according to the OECD Guideline 405 (1987) and EU method B.5 (1992). 0.1 g of undiluted, solid test item was administered to the left conjunctival sac of three rabbits (one male and two female) and was not rinsed. Observations and irritation scores were recorded at 1, 24, 48 and 72 hours and 7, 14 and 21 days after application of the test item.

Irritation scores for all parametres were calculated as means at 24, 48 and 72 hours. All irritation scores were 0.0 at these timepoints. Black or light black staining of the cornea was reversible in one test animal after 72 hours and in a second test animal after 21 days. The third test animal showed light black corneal staining until the end of the study period (21 days). Black or light black stainging of the nictitating membrane was observed in all three test animals until the end of the study period (21 days). No corrosive effect was observed.

Justification for classification or non-classification

Skin Irritation/Corrosion

According to the CLP criteria (EC 1272/2008) for skin corrosion and irritation a substance is classified as corrosive to the skin (Category 1) if it produces irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, in at least 1 test animal following the application of a test substance for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, discolouration due to blanching of the skin after 14 days, complete areas of alopecia, and scars. Skin corrosives can be further divided into 3 sub-categories:

- Sub-Category 1A: corrosive responses in at least one animal following exposure ≤ 3 min during an observation period ≤ 1 h

- Sub-Category 1B: corrosive responses in at least one animal following exposure > 3 min and ≤ 1 h and observations ≤ 14 days

- Sub-Category 1C: corrosive responses in at least one animal after exposures > 1 h and ≤ 4 h and observations ≤ 14 days

A substance is classified as a skin irritant (Category 2) if:

(i) it produces reversible damage (mean score of ≥ 2.3 and ≤ 4.0 for erythema and/or oedema at 24, 48 and 72 hours after removal) following the application of a test substance for ≤ 4 hours in at least 2 of 3 tested animals; or

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

(iii) very definite positive effects related to chemical exposure are apparent in a single animal but it does not meet the criteria above.

According to the study available, the mean irritation scores (both erythema and oedema were 0) for the test item do not satisfy the abovementioned criteria for Category 1: Skin Corrosive or Category 2: Skin Irritant.

Eye Irritation/Corrosion Criteria

According to the CLP criteria (EC 1272/2008) for serious eye damage and eye irritation, a substance is classified as:

- Category 1: Serious Eye Damage if it produces

(i) effects on the cornea, iris or conjunctiva which are not reversible within 21 days in at least one animal, and/or

(ii) a positive response of corneal opacity (mean score ≥ 3) or iritis (mean score > 1.5) in at least 2 of 3 animals,

following grading at 24, 48 and 72 hours after application of the test material to the anterior surface of the eye.

A substance is classified as Category 2:

Eye Irritant if it produces a positive response of corneal opacity (mean score 1), iritis (mean score 1), conjunctival redness (mean score 2) and/or chemosis (mean score 2) in at least 2 of 3 animals

following grading at 24, 48 and 72 hours after application of the test material to the anterior surface of the eye which is fully reversed within 21 days.

All irritation scores recorded at 24, 48 and 72 hours were 0.0. Black or light black stainging of the nictitating membrane was observed in all three test animals until the end of the study period (21 days). The available data demonstrated that corneal staining was not reversible within 21 days only in one animal. As the substance has a harmonised classification in Annex VI of the CLP Regulation (EC 1272/2008), the classification of the test item as Category 1: Serious Eye Damage is warranted.