Registration Dossier
Registration Dossier
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EC number: 261-818-3 | CAS number: 59587-38-1
Endpoint summary
Administrative data
Description of key information
Skin: OECD TG 439, in vitro reconstructed human epidermis test. Predicted to be a non-irritant. Reliability = 1
Eye: OECD TG 437, in vitro bovine corneal opacity and permeability test. An IVIS scoring of 7.3 is obtained for the test article diluted at 20% and pH of 5.0. Reliability = 1
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
The skin irritation potential of the test substance was evaluated based upon measuring the relative conversion of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) in the test substance-treated tissues after exposure to the test article for a 60-minute exposure period, followed by a 42-hour post-exposure expression period in accordance with OECD guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method). Skin irritation potential of the test substance was predicted if the relative viability was less than or equal to 50%. The test article was not observed to directly reduce MTT in the absence of viable cells. The mean viability of the test substance was 101.0% and the test substance is predicted to be a non-irritant.
The potential ocular irritancy of the test substance, as measured by changes in opacity and permeability (to fluorescein) in isolated bovine corneas was examined in accordance with OECD guideline 437. Bovine corneas were incubated in the presence of the test substance at 32 ± 1ºC for 4 hours. The test substance was determined to have an in vitro score of 7.3.
Justification for classification or non-classification
Based on in vitro skin irritation assay, scoring 101% viability, the test substance is not classified for skin irritation, in accordance with Regulation (EC) No 1272/2008 (CLP).
Based on in vitro eye irritation assay, the test substance is classified for eye irritation cat. 2, in accordance with Regulation (EC) No 1272/2008 (CLP).
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