Registration Dossier
Registration Dossier
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EC number: 271-234-0 | CAS number: 68526-85-2
Endpoint summary
Administrative data
Description of key information
Irritating to the skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin
Isodecanol was administered via an occluded patch to 6 rabbits at a dose of 0.5 ml for 4 hours of exposure to assess dermal irritation. Observations were conducted at 45 minutes, 24, 48 and 72 hours and 7 days after exposure. Well defined erythema was noted in 1 animal at the 45 minute point while the other animals had very slight erythema. Erythema increased after the 45 minute interval. Five animals were noted with well-defined erythema at the 24 and 48 hour intervals; the mean primary dermal irritation index was 2.16. At the 72 hour interval, all animals were noted with well-defined erythema. Erythema increased again at the Day 7 interval; two animals were noted with severe erythema and four animals were noted with well-defined erythema. The mean skin irritation scores between 24 and 72 hours were: erythema 1.5 and edema 0.56. Four of six animals exhibited desquamation by day 7, and the other 2 of 6 animals exhibited exfoliation.
Eye
Isodecanol was evaluated for acute eye irritation by a single instillation of 0.1 ml into the left eye of 6 rabbits. Slight to moderate eye irritation was observed within 1 h post instillation and included slight corneal opacity, slight iritis, and slight to moderate conjunctival redness. All signs of irritation were resolved by Day 7 post exposure. Mean eye irritation scores between 24 and 72 hours were: cornea score 0.5, iris score 0.5, and conjunctival redness 1.54.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
The data for the substance identified by CAS number 68526-85-2, subject of this registration, was demonstrated in a well-documented GLP study conducted according to recognized testing methodologies to produce skin irritation. This assessment is based on desquamation noted in 4 of 6 animals and exfoliation in the other 2 of 6 animals at Day 7.
Isodecanol CAS number 68526-85 -2 is therefore classified as irritant to skin according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) and the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.
No classification for eye irritation is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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