Registration Dossier
Registration Dossier
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EC number: 227-101-4 | CAS number: 5655-61-8
Endpoint summary
Administrative data
Description of key information
Skin irritation: Key study: Test method OECD 404.GLP study: Based on the read-across approach, laevo bornyl acetate was determined to be not irritating to the skin in accordance with CLP Regulation (EC) no. 1272/2008 and as irritating to the skin (Xi, R38) according to Directive 67/548/EEC.
Eye irritation: Key study: Test method OECD 405.GLP study: Based on the read-across approach, laevo bornyl acetate was determined to be not irritating to the eye.
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: Key study: Read-across approach from experimental data on the analogue isobornyl acetate:
An in-vivo skin irritation test was performed on the analogue substance isobornyl acetate according to OECD 404. Three New Zealand White rabbits were exposed to 0.5 mL (unchanged) test sample under semi-occlusive conditions for 4 hours. After patch removal, the rabbits were observed at 30 -60 min, 24, 48 and 72 hours and 7 days. Two rabbits showed erythema score of 2 at mean 24 -72h time period, which was fully reversible by day 7. No edema was observed. Based on these results, the read-across approach was applied and laevo bornyl acetate was determined to be not irritating to the skin in accordance with CLP Regulation (EC) no. 1272/2008 and as irritating to the skin (Xi, R38) according to Directive 67/548/EEC.
Eye irritation: Key study: Read-across approach from experimental data on the analogue isobornyl acetate:
An in-vivo eye irritation test was performed on the analogue substance isobornyl acetate according to OECD Guideline 405. The right eye of three New Zealand White rabbits were exposure to 0.1 mL (unchanged) test sample. The other one was used as control. The effects were observed after 1, 24, 48 and 72 hours exposure. Two rabbits showed a chemosis score of 0.33 (mean 24 -72h) which was fully reversible after 48 hours of exposure. One rabbit showed a conjunctivae score of 0.66 (mean 24 -72h) which was fully reversible after 72 hours of exposure. Based on these results, the read-across approach was applied and laevo bornyl acetate was determined to be not irritating to the eye.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available.
Justification for classification or non-classification
Based on the available information, laevo bornyl acetate is not classified for skin irritation and eye irritation in accordance with CLP Regulation (EC) no. 1272/2008. Besides, it is classified as irritating to skin (Xi, R38) according to Directive 67/548/EEC.
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