Registration Dossier
Registration Dossier
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EC number: 943-526-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin Irritation: non irritant
Eye Irritation, category 2 (H319)
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 (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
In the key study, the mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in at least 2 of 3 animals for both erythema/eschar and oedema reactions.
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 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
The mean values from gradings at 24, 48 and 72 hours for not-rinsed eyes were 1/1.66 for corneal opacity, 1 for iritis, 3 for redness and lower than 2 for chemosis in 3/3 animals. The rinsed-eye animals showed a gradings at 24, 48 and 72 hours of 1 for corneal opacity, 1 for iritis, higher than 2 for redness and lower than 2 for chemosis in 3/3 animals. Despite in all cases symptoms were not fully recorded withing the observation period of 8 days, the severity decreses and are expected to be recovered within 21 days. The substance is not expected to be cause severe eye damage.
In conclusion, the substance does not meet the criteria to be classified as skin irritant; on the contrary, a classification as eye irritant, category 2 (H319), according to the CLP Regulation(EC 1272/2008), is applied.
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