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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 946-636-0 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Well conducted study with limited detailed information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Octahydro-3,8,8-trimethyl-6-methylene-1H-3a,7-methanoazulen-5-ol
- EC Number:
- 248-917-7
- EC Name:
- Octahydro-3,8,8-trimethyl-6-methylene-1H-3a,7-methanoazulen-5-ol
- Cas Number:
- 28231-03-0
- Molecular formula:
- C15H24O
- IUPAC Name:
- Cedr-8(15)-en-9-ol
- Test material form:
- not specified
- Details on test material:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: obtained from sponsor, Material number 74-172
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: obtained from sponsor, Material number 74-172
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 (Sex unspecified)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: Not specified
- Other examinations performed: Clinical signs
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- None
- Body weight:
- Not reported
- Gross pathology:
- Not reported
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Based on CLP Criteria
- Conclusions:
- The oral LD50 value of Cedrenol in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified for acute oral toxicity according to the criteria laid down in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The acute toxic potential of Cedrenol was assessed in an acute oral toxicity limit test performed in 10 rats. The rats were exposed to 5000mg/kg bw Cedrenol via the oral route, and observed for clinical signs and mortality over an examination period of 14 days. Daily observations were performed. At the end of the study period no mortality was observed in any of the animals. Furthermore no symptoms occured in the test animals. The LD50 for acute oral toxicity was therefore set at >5000 mg/kg bw. Based on these results Cedrenol does not have to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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.
