Registration Dossier
Registration Dossier
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EC number: 915-335-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin corrosion: Not corrosive based on an OECD TG 404 test.
Skin irritation: Not irritating based on an OECD TG 404 test.
Eye irritation: Not irritating based on an OECD TG 405 test.
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
Skin Irritation
In a skin irritation/corrosion study, performed similar to OECD 404 and following GLP principles, four female New Zealand white rabbits were exposed to 0.5 ml of undiluted test material and 0.5 ml of a 50% solution under semi-occlusive conditions. After 4 hours, the test substance was removed by gentle swabbing with cotton wool soaked in warm water, and animals were observed for 7 days. Following 4-hour treatment with the undiluted material, the mean erythema scores of the four rabbits were 2 for all rabbits (mean scores 24, 48, and 72 hours after removal of the substance). The mean oedema scores over this time period were 2, 1.67, 2, and 2, respectively. Most of the effects were not reversible within 7 days. Based on the edema and erythema scores being <2.3 (but higher than 1.5), the substance is considered not to be corrosive or an irritant.
Eye Irritation
In an eye irritation study, performed similar to OECD 405 and following GLP principles, 0.1 mL of undiluted test substance was applied to six rabbit eyes followed by examinations at 24-, 48 and 72-hours and at day 7 days following treatment. The following results were obtained and expressed as mean scores 24, 48, and 72 hours after removal of the substance: Corneal opacity (score 1) was observed in 2 out of 6 animals. Iritis (Score 0.33) was observed in 3 out of 6 animals. Conjunctivae redness was observed in 5 out of 6 animals with scoring of 0.33, 0.67, 1 (2 animals), and 2, respectively. Chemosis was observed in 4 out of 6 animals with scoring of 0.33 (2 animals), and 1.33 (2 animals). All effects were cleared with 7 days. The substance is not considered to be an eye irritant.
Justification for classification or non-classification
Based on the results of the available skin and eye irritation in vivo studies, classification of the substance for skin and eye irritation is not warranted according to EU CLP (EC 1272/2008 and its amendments).
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