Registration Dossier
Registration Dossier
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EC number: 209-269-0 | CAS number: 564-20-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 15 to May 3, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The study was performed prior to the OECD test guideline No. 401 but the protocol is similar to the TG. Test material information are lacking.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Study was performed according to procedure suggested by Hagan in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The association of Food and Drug Officials of the United States, 1975), pp 17-45
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- [3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
- EC Number:
- 209-269-0
- EC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
- Cas Number:
- 564-20-5
- Molecular formula:
- C16H26O2
- IUPAC Name:
- [3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: from a suitable licensed dealer.
- Age at study initiation: 6 to 8 weeks of age
- Weight at study initiation: 180-258 g
- Fasting period before study: 18 hours.
- Housing: galvanized cages with indirect bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 2 days
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): temperature controlled room
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% - 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: 1, 3, 6 and 24 hours after treatment, and dialy thereafter.
- Frequency of weighting: at Day 1 and Day 14
- Necropsy of survivors performed: Yes; non-survivors and animals sacrificed at the end of the 14-day observation period were subjected to gross necropsy. - Statistics:
- No
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0/5 (M); 0/5 (F)
- Clinical signs:
- other: No effect
- Gross pathology:
- One animal showed fibrous tissue encrasing heat. No effects in the others.
- 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 LD50 Combined > 5000 mg/kg bw
- Executive summary:
In an acute oral toxicity study, groups of Wistar rats (5/sex/dose) were administered a single oral (gavage) dose of test material suspended at 25% in corn oil at 5000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
The test material was not toxic orally to rats under conditions of this test. The internal organ on superficial examination appeared normal, excep for a deposit of fibrous tissue in the thoracic cavity of one animal.
Oral LD50 Combined > 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.
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