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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 208-008-8 | CAS number: 505-32-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Peer-reviewed data, available as short summary from secondary source, reliability according to HPV/ICCA SIDS.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Acute toxicity studies. Report to RIFM, unpublished.
- Author:
- Moreno OM
- Year:
- 1 982
- Bibliographic source:
- RIFM-FEMA Database, Location 1689
- Reference Type:
- secondary source
- Title:
- Acute toxicity studies. Report to RIFM, unpublished.
- Author:
- Moreno OM
- Year:
- 1 982
- Bibliographic source:
- Cited in: OECD SIDS Isophytol; SIAM 16 (2003-02-20)
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Single dermal application of the test substance to clipped, intact or abraded abdominal skin under occluded patches for 24 hours.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- EC Number:
- 208-008-8
- EC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Cas Number:
- 505-32-8
- Molecular formula:
- C20H40O
- IUPAC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Isophytol
- Physical state: no data
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals, sex not further specified
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and/or systemic effects daily, dermal reactions on days 1, 7 and 14; no data on weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, dermal reactions
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality occurred
- Clinical signs:
- other: "Few faeces, moderate/severe skin reactions"
- Gross pathology:
- 2/10: "treated skin and intestinal abnormalities"
Any other information on results incl. tables
No deaths occurred at a limit dose of 5000 mg/kg bw during the observation period. As the principal toxic sign, "few faeces" were observed. Skin reactions were described as "moderate/severe", without further details. At necropsy, 8 animals were without diagnostic findings, while 2 showed "treated skin and intestinal abnormalities"; these abnormalities were not described in detail.
Conclusion:
The acute dermal LD50 for isophytol is greater than 5000 mg/kg bw. Observations during 14 days after application and necropsy showed skin abnormalities at treated sites in 2/10 animals and some changes to the function and structure of the digestive tract, all of which were judged to be related to isophytol.
Applicant's summary and conclusion
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.
