Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 227-101-4 | CAS number: 5655-61-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Additional information
Data waiving (other justification): In accordance with Column 2 of REACH Annex VIII, the study does not need to be conducted since a pre-natal developmental toxicity study is available.
Short description of key information:
Data waiving (other justification): In accordance with Column 2 of REACH Annex VIII, the study does not need to be conducted since a pre-natal developmental toxicity study is available.
Justification for selection of Effect on fertility via oral route:
In accordance with Column 2 of REACH Annex VIII, the study does not need to be conducted since a pre-natal developmental toxicity study is available.
Effects on developmental toxicity
Description of key information
Key study: Test method OECD 414, GLP study: Based on the read-across approach, the NOEL for maternal and developmental toxicity after an oral exposure of laevo bornyl acetate was determined to be 1000 mg/kg bw/day in rats.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study has a Klimisch score = 2.
Additional information
Key study: Read-across approach from experimental data on the analogue substance isobornyl acetate:
A pre-natal developmental toxicity test was performed with the analogue substance isobornyl acetate according to OECD Guideline 414. 20 female Wistar rats from were exposed by gavage to 0 (control) and 1000 mg/kg bw/day test item between Days 7 and 16 of gestation, in a limit test. On Day 21 of gestation, the animals were killed and both dams and fetus were examined. No substance related effects were observed on dams. The morphological examination of fetuses revealed no evidence of embryotoxic and teratogenic effects related to the test item. The NOEL of isobornyl acetate for maternal, ebryo/fetal toxicity and teratogenicity was determined to be 1000 mg/kg bw/day in rats. Based on these results, the read-across approach was applied and the NOEL of laevo bornyl acetate was determined to be 1000 mg/kg bw/day for maternal and developmental toxicity in rats.
Justification for selection of Effect on developmental toxicity: via oral route:
Only one study available.
Justification for classification or non-classification
Based on the available information, the substance is not classified for toxicity to reproduction in accordance with CLP Regulation (EC) no 1272/2008.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
