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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 283-911-8 | CAS number: 84775-83-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Salvia sclarea, Labiatae.
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study, the oral LD50 of test substance was 5600 mg/kg bw with 95 % confidence limits of 5000-6200 mg/kg bw in male rats. (Pre-GLP, Rel. K2)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- no guideline available
- Principles of method if other than guideline:
- Standard acute method
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test item: Compound No. 72-8-48
- Source of test material: Research Institute for Fragrance Materials, Inc., USA.
- Physical state: Clear liquid
- Date of receipt: 06 April 1972 - Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-250 g
- Fasting period during the study: Animals were fasted for a minimum of 16 h prior to administration of the test item.
- Diet: Food, ad libitum
- Water: Water, ad libitum - Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Test substance was administered as a concentrate.
- Doses:
- 4000, 5000, 6250 and 7800 mg/kg bw
- No. of animals per sex per dose:
- 10 males/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made at 1 and 6 h after dosing and daily thereafter for 14 days.
- Necropsy of survivors performed: Yes; all surviving animals were sacrificed for gross necropsy examination. - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 5 000 - 6 200
- Mortality:
- - Deaths occurred overnight following administration of test substance.
- 1/10, 4/10, 7/10 and 10/10 animals were died at 4000, 5000, 6250 and 7800 mg/kg bw, respectively. - Clinical signs:
- other: Rats experienced lethargy, diarrhea and urinary incontinence.
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute oral toxicity study, groups (10 males/dose) of Wistar rats were given a single oral dose of test substance at 4000, 5000, 6250 and 7800 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were sacrificed for macroscopic examination.
Rats experienced lethargy, diarrhea and urinary incontinence. Deaths occurred overnight following administration of test substance. 1/10, 4/10, 7/10 and 10/10 animals were died at 4000, 5000, 6250 and 7800 mg/kg bw, respectively. In this study, the oral LD50 of test substance was 5600 mg/kg bw with 95 % confidence limits of 5000-6200 mg/kg bw in male rats.
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 600 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5000 mg/kg bw
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.
