Registration Dossier
Registration Dossier
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EC number: 271-360-6 | CAS number: 68551-08-6
Endpoint summary
Administrative data
Description of key information
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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
Isoundecanol was administered via an occluded dermal patch to 6 rabbits at a dose of 0.5 ml neat solution for 4 hours to assess the skin irritation potential. Dermal evaluations occurred at 45 minutes, 24h, 48h, 72h, and 7 days post patch removal. Application sites were graded for erythema, edema, and other signs of dermal irritation according to the Draize method of scoring. Signs of erythema were noticed in all animals at 45 minutes post patch removal; ranging from very slight to slight. At the 72h observation point, erythema had increased in severity in all animals; ranging from very slight to moderate/severe with signs of edema. Irritation decreased after 72h and by Day 7, 3 animals were clear of erythema and edema while the remaining 3 animals exhibited very slight erythema and very slight edema. The mean skin irritation scores between 24 and 72 hours were: erythema 1.83 and edema 1.5.
Eye
Isoundecanol was administered via instillation into the eye to 6 rabbits at a dose of 0.5 ml neat solution. Ocular examinations occurred at 1h, 4h, 24h, 48h, 72h, Day 4, Day 7, Day 10, and Day 14 post instillation. Ocular damaged was assessed and scored according to the Draize eye test. All animals survived the exposure. Ocular irritation was most prominent at the 1 and 4 h observation point where the total Draize score ranged from 2 to 19. Irritation subsided as the study progressed and by Day 14, 2 animals were clear of ocular irritation. The remaining 4 animals exhibited conjunctival redness with a corresponding Draize score of 1. The eye irritation potential for isotridecanol is minimal. Mean eye irritation scores between 24 and 72 hours were: cornea score 0, iris score 0.05, and conjunctival redness 1.27.
Justification for selection of eye irritation endpoint:
Reversable effects that do not require classification.
Justification for classification or non-classification
No classification for 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.
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