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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 264-119-1 | CAS number: 63393-93-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (test substance purity not specified, limited documentation, no necropsy and no histopathology were performed).
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
- Reference Type:
- secondary source
- Title:
- Final report of the safety assessment for Isopropyl Lanolate.
- Author:
- CIR
- Year:
- 1 980
- Bibliographic source:
- Journal of environmental pathology, toxicology and oncology;4/4, 121-132, 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- test substance purity not specified, limited documentation, no necropsy and no histopathology were performed
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Fatty acids, lanolin, iso-Pr esters
- EC Number:
- 264-119-1
- EC Name:
- Fatty acids, lanolin, iso-Pr esters
- Cas Number:
- 63393-93-1
- Molecular formula:
- UVCB
- IUPAC Name:
- Fatty acids, lanolin, isopropyl esters
- Details on test material:
- - Name of test material (as cited in study report): isopropyl lanolate, distilled
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: 24 hours
- Housing: Animals on the same dosage level were placed in a common cage.
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2.0, 4.0, 8.0, 16.0, 32.0 and 64.0 mL/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily for a 2 week period
- Necropsy of survivors performed: no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 54 400 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Calculated by 64 mL with a density of 850 mg/mL
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: The animals of the 2 highest dosage levels (32.0 and 64.0 mL/kg bw) exibited passive behavior patterns and had mild diarrhea.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
