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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-686-4 | CAS number: 57345-19-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May, 14 1997 to June, 24 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- rel-(3S,5aR,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Molecular formula:
- C18H30O2
- IUPAC Name:
- rel-(3S,5aR,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Reference substance name:
- rel-(3R,5aS,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
- Cas Number:
- 220432-47-3
- Molecular formula:
- C18H30O2
- IUPAC Name:
- rel-(3R,5aS,7aR,11aR,11bS)-3,8,8,11a-tetramethyldodecahydro-5H-3,5aepoxynaphtho[2,1-c]oxepine
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Lot No.: 2007806
Purity: 98.9 % (major peak)
Expiration date: 17-04-1997
Test animals
- Species:
- rat
- Strain:
- other: HanIbrn: Wist (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd, Wölferstrasse 4, 4414 Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks (Males) and 10 weeks (Females)
- Weight at study initiation: 201 - 212 g (Males) and 172 - 185 g (Females)
- Housing: Groups of in Makrolon type-4 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, batch nos 84/87 and 86/97 rat maintenance diet available ad libitum
- Water (e.g. ad libitum): Community tap water available ad libitum
- Acclimation period: One week under laboratory conditions after health examination.
- Temperature (°C): 22°C
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: corn oil
- Details on oral exposure:
- The test article was suspended in vehicule (corn oil) at a concentration of 0.2 mg/L and administered at a volume of 10 ml/Kg.
- Doses:
- 2000mg/Kg BW
- No. of animals per sex per dose:
- 1 dose per animal per sex
- Control animals:
- no
- Details on study design:
- The animals were examined for clinical signs four times during day 1 and once daily during days 2 - 15.
Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and days 8 and 15. All animals were necropsied and examined macroscopically.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study
- Clinical signs:
- other: No clinical signs of toxicity were observed during the observation period
- Other findings:
- No macroscopic organ findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean lethal dose of Amberketal after single oral administration to rats of both sexes observed over a period of 14 days , could not be estimated as no death poccured
LD50 > 2000 mg/Kg BW - Executive summary:
A group of five male and female rats was treated with Amberketal at 2000 mg/Kg by oral gavage accoridng to the OECD guideline No. 401.
The test article was suspended in vehicule (corn oil) at a concentration of 0.2 mg/L and administered at a volume of 10 ml/Kg.
The animals were examined for clinical signs four times during day 1 and once daily during days 2 - 15.
Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and days 8 and 15. All animals were necropsied and examined macroscopically.
No deaths occurred during the study.
No clinical signs of toxicity were observed during the observation period
The body weight of animals was within the range of physiological variability known for rats of this strain and age
No macroscopic organ findings were observed at necropsy.
The mean lethal dose of Amberketal after single oral administration to rats of both sexes observed over a period of 14 days , could not be estimated as no death poccured
LD50 > 2000 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.
