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
Key study: Test method similar to OECD 408. No data on GLP. Based on the read-across approach, the NOEL for laevo bornyl acetate after an oral exposure of 13 weeks was determined to be 15 mg/kg bw/day in rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 15 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The study has Klimisch score 2.
Additional information
Key study: Read-across from experimental data on the analogue isobornyl acetate.
A repeated dose toxicity study was performed with the analogue substance isobornyl acetate (test method similar to OECD 408). Rats were exposed to 0 (control), 15, 90 or 270 mg/kg bw/day by gavage during 13 weeks. In male rats given 270 mg/kg bw/day there was a decrease in renal concentrating ability, an increase in water intake, exfoliation of renal tubular cells, increased kidney weight and vacuolation of the renal tubular cells. Signs of nephrotoxicity were also seen with daily doses of 90 mg/kg bw/day. Vacuolation of the epithelium of the intrahepatic bile-duct and increase in liver weights were found at 270 mg/kg bw/day. The caecum were also enlarged at this dosage level. The NOEL was determined to be 15 mg/kg bw/day. Based on these results, the read-across approach was applied and the NOEL for laevo bornyl acetate after an oral exposure of 13 weeks was determined to be 15 mg/kg bw/day in rats.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Only one study available.
Justification for classification or non-classification
Based on the available data, laevo bornyl acetate is not classified for specific target organ toxicity by repeated exposure (STOT-RE) according to CLP Regulation (EC) no 1272/2008.
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