Registration Dossier
Registration Dossier
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EC number: 925-425-7 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 17 - June 17 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-yl acetate
- EC Number:
- 260-555-1
- EC Name:
- [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-yl acetate
- Cas Number:
- 57082-24-3
- Molecular formula:
- C17H28O2
- IUPAC Name:
- 4,4,8-trimethyltricyclo[6.3.1.0~2,5~]dodec-1-yl acetate
- Reference substance name:
- 1-((1S,2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-en-9-yl)ethan-1-one
- Molecular formula:
- C17H26O
- IUPAC Name:
- 1-((1S,2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-en-9-yl)ethan-1-one
- Reference substance name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-yl acetate
- Cas Number:
- 77346-43-1
- Molecular formula:
- C17H28O2
- IUPAC Name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-yl acetate
- Reference substance name:
- 1-((1S,2S,5R,9S)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-7-en-9-yl)ethan-1-one
- Cas Number:
- Not applicable
- Molecular formula:
- C17H26O
- IUPAC Name:
- 1-((1S,2S,5R,9S)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-7-en-9-yl)ethan-1-one
- Reference substance name:
- 4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-ol
- EC Number:
- 207-458-2
- EC Name:
- 4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-ol
- Cas Number:
- 472-97-9
- Molecular formula:
- C15H26O
- IUPAC Name:
- 4,4,8-trimethyltricyclo[6.3.1.0~2,5~]dodecan-1-ol
- Reference substance name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-ol
- Cas Number:
- 62560-57-0
- Molecular formula:
- C15H26O
- IUPAC Name:
- (3S,3aS,7R,9aS)-1,1,7-trimethyldecahydro-3a,7-methanocyclopenta[8]annulen-3-ol
- Reference substance name:
- 2,2,4,7a-tetramethyl-1,2,3,6,7,7a-hexahydro-1,3a-ethanoindene
- Cas Number:
- 4545-68-0
- Molecular formula:
- C15H24
- IUPAC Name:
- 2,2,4,7a-tetramethyl-1,2,3,6,7,7a-hexahydro-1,3a-ethanoindene
- Reference substance name:
- not applicable
- Cas Number:
- not applicable
- Molecular formula:
- not applicable
- IUPAC Name:
- not applicable
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
- Specific details on test material used for the study:
- Name (as stated in the report): VETYVENAL
Batch: 285526
Expiration date: March 25, 2003
Test animals
- Species:
- rat
- Strain:
- other: HanBrl: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 3 males and 3 females (Rat, HanBrl: Wist (SPF)) were used when treated respectively: 8 weeks and 10 weeks old. By unique cage number and corresponding color-coded spots on the tail. Under laboratory conditions, after health examination, only animals without any visible signs of illness were used for the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- The animals received a single dose of the test article on a 2000 mg/kg body weight basis by oral gavage following fasting for 16.5 and 18.5 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
The application volume was 10 ml/kg body weight.
Rationale: Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article. - Doses:
- The dose formulations were made shortly before each dosing occasion. The concentration of the test item dosage was: 2000 mg/kg body weight (single dose). The test item was diluted in vehicule (PEG 300) at a concentration of 0.2 mg/l and administered at a volume dosage of 10 ml/kg.
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
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 death occurred during the study.
- Clinical signs:
- No clinical signs were observed during the study period.
- Body weight:
- The body weight of the animals was within the range commonly recorded for this strain and age.
- Other findings:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of VETYVENAL after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occured.
LD50(rat): greather than 2000 mg/kg body weight. - Executive summary:
Two groups, each using three male or three female HanBrl: WIST (SPF) rats were treated with VETYVENAL at 2000 mg/kg by oral gavage. The test article was suspended in vehicle (polyethylene glycol PEG 300) 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 test day 1 and once daily during test 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 on days 8 and 15.
All animals were necropsied and examined macroscopically.
No death occurred during the study.
No clinical signs were observed in the females during the course of the study.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
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