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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 942-425-2 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 14 to June 28, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study comparable to OECD test guideline No. 401 but GLP status not reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Section 1500.3 - Federal Hazardous Substances Act Regulations - 16 CFR
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (3R*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Molecular formula:
- C15H30O
- IUPAC Name:
- (3R*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Reference substance name:
- (3S*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Molecular formula:
- C15H30O
- IUPAC Name:
- (3S*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol
- Test material form:
- not specified
- Details on test material:
- - Physical state: no data
- Sample received: 1984-06-04
- Storage condition of test material: no data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA.
- Age at study initiation: no data
- Weight at study initiation: 200-300 g
- Fasting period before study: overnight deprivation of food
- Housing: 5 rats/cage by sex, in stainless steel cages with elevated wire mesh flooring
- Diet (e.g. ad libitum): Wayne Lab-Blox ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: appropriate time
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- None
- Doses:
- 5000 mg/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: frequently on the day of dosage, and twice per day thereafter.
- Frequency of weighing: on the day of dosage (individually), and on Day 7 and 14 after dosing (grouped)
- Necropsy of survivors performed: yes, gross examinations - Statistics:
- none
Results and discussion
- Preliminary study:
- not applicable
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: All animals appeared normal throughout the 14 day observation period
- Gross pathology:
- No gross abnormalities
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Oral LD50Combined > 5000 mg/kg bw.
Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS. - Executive summary:
In a limit acute oral toxicity study performed similarly to the OECD test guideline No. 401, a group of fasted, Sprague-Dawley rats (5/sex) was administered a single oral dose of undiluted test material at 5000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.
No mortality and no clinical signs were observed throughout the study. There was no adverse effect on bodyweight gain. No gross abnormalities were observed at necropsy.
Oral LD50Combined > 5000 mg/kg bw
Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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.
