Registration Dossier
Registration Dossier
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EC number: 248-607-1 | CAS number: 27689-12-9
Endpoint summary
Administrative data
Description of key information
A Primary Skin Irritation study and an Eye Irritation study have been conducted on Procrylat. The substance was non-irritating to the eyes and non-irritating to the skin.
Key value for chemical safety assessment
Additional information
A Primary Skin Irritation study and an Eye Irritation study have been conducted on Procrylat. The substance was non-irritating to the eyes and non-irritating to the skin.
The primary eye irritation/corrosion potential of the test article (liquid, batch P2274001) was evaluated in New Zealand White Rabbits. This study was performed in accordance with Swiss GLP (1986), OECD GLP (1992), US FDA GLP 21CFR58, Japan MHLW (1988). The study design was based on Directive 92/69/EEC, B.5 (1992) and OECD 405 (1987). The test material (0.1 mL) was administered as received to the conjunctival sac of one eye of each rabbit (1 male, 2 females) by gently pulling the lower eyelid away from the eye. The lids were held together for approximately one second after administration to insure adequate distribution of the test material. The contralateral eye of each animal served as the control. The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours postdose using the Draize technique. There were no systemic clinical signs, corneal opacity, iritis or conjunctival chemosis at any time during the study. Conjunctival redness was observed in all animals at 1 hour after dosing (score: 1, one animal and 2, two animals; average: 1.67) that persisted through 48 hours after dosing (scores: 1; average 1.00). All animals were normal at 72 hours after dosing. The individual animal mean conjuctival redness scores (24 -72 hours) were 0.67, 0.67, and 0.67. The mean total score for ocular irritation was 0.67/110. Based on the results of the study, the test article is not an ocular irritant.
The primary skin irritation potential of the test article (liquid, batch P2274001) was evaluated in New Zealand White rabbits. This study was conducted in accordance with Swiss GLP (1986), OECD GLP (1992), US FDA GLP 21CFR58, Japan MHLW (1988). The study design was based on Directive 92/69/EEC, B.4 (1992) and OECD 404 (1993). The test article was administered as received. Hair was clipped from the dorsal skin of three rabbits (1 male, 2 females). The test article (0.5 mL) was applied to a 6 cm2 area on the skin. Gauze was used to cover the site and create a semi-occlusive dressing. The dressing was secured around the abdomen with tape for a 4-hour exposure. Observations for skin irritation (erythema and edema) were recorded at 1, 24, 48 and 72 hours after unwrapping. The Primary Irritation Index (PII) was calculated. There were no abnormal clinical signs or changes in body weight. All erythema and edema scores were 0 throughout the study and the PII was 0. Based on the results of this study (all scores were 0; PII = 0), the test article is not a dermal irritant.
Justification for classification or non-classification
Procrylat does not meet the CLP classification criteria for eye or skin irritation.
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