Registration Dossier
Registration Dossier
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EC number: 282-031-1 | CAS number: 84082-84-8
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- 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
Test material
- Reference substance name:
- rel-((3aR,6R)-7,7-dimethyl-8-methyleneoctahydro-1H-3a,6-methanoazulen-3-yl)methyl acetate
- Molecular formula:
- C17H26O2
- IUPAC Name:
- rel-((3aR,6R)-7,7-dimethyl-8-methyleneoctahydro-1H-3a,6-methanoazulen-3-yl)methyl acetate
- Reference substance name:
- 2-(8,8a-dimethyl-3,4,6,7,8,8a-hexahydronaphthalen-2(1H)-ylidene)propyl acetate
- Molecular formula:
- C17H26O2
- IUPAC Name:
- 2-(8,8a-dimethyl-3,4,6,7,8,8a-hexahydronaphthalen-2(1H)-ylidene)propyl acetate
- Reference substance name:
- rel-(8R,8aS)-8,8a-dimethyl-2-(propan-2-ylidene)-1,2,3,7,8,8a-hexahydronaphthalene
- Molecular formula:
- C15H22
- IUPAC Name:
- rel-(8R,8aS)-8,8a-dimethyl-2-(propan-2-ylidene)-1,2,3,7,8,8a-hexahydronaphthalene
- Reference substance name:
- rel-(5R,10R)-6,10-dimethyl-2-(propan-2-ylidene)spiro[4.5]dec-6-en-8-one
- Cas Number:
- 22196-46-9
- Molecular formula:
- C15H22O
- IUPAC Name:
- rel-(5R,10R)-6,10-dimethyl-2-(propan-2-ylidene)spiro[4.5]dec-6-en-8-one
- Reference substance name:
- rel-(4R,4aS)-4,4a-dimethyl-6-(propan-2-ylidene)-4,4a,5,6,7,8-hexahydronaphthalen-2(3H)-one
- Cas Number:
- 16981-90-1
- Molecular formula:
- C15H22O
- IUPAC Name:
- rel-(4R,4aS)-4,4a-dimethyl-6-(propan-2-ylidene)-4,4a,5,6,7,8-hexahydronaphthalen-2(3H)-one
- Reference substance name:
- rel-(1R,8aS)-1,8a-dimethyl-7-(propan-2-ylidene)-1,2,3,7,8,8a-hexahydronaphthalene
- Molecular formula:
- C15H22
- IUPAC Name:
- rel-(1R,8aS)-1,8a-dimethyl-7-(propan-2-ylidene)-1,2,3,7,8,8a-hexahydronaphthalene
- Reference substance name:
- 2-methoxy-4-prop-1-enylphenyl acetate
- EC Number:
- 202-236-1
- EC Name:
- 2-methoxy-4-prop-1-enylphenyl acetate
- Cas Number:
- 93-29-8
- Molecular formula:
- C12H14O3
- IUPAC Name:
- 2-methoxy-4-(prop-1-en-1-yl)phenyl acetate
- Reference substance name:
- rel-(1R,4aS,8aR)-1,4a-dimethyl-7-(prop-1-en-2-yl)-1,2,3,4,4a,5,6,8a-octahydronaphthalene
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1R,4aS,8aR)-1,4a-dimethyl-7-(prop-1-en-2-yl)-1,2,3,4,4a,5,6,8a-octahydronaphthalene
- Reference substance name:
- rel-(3aR,6R,8aR)-7,7-dimethyl-8-methylenehexahydro-1H-3a,6-methanoazulen-3(2H)-one
- Cas Number:
- 64550-95-4
- Molecular formula:
- C14H20O
- IUPAC Name:
- rel-(3aR,6R,8aR)-7,7-dimethyl-8-methylenehexahydro-1H-3a,6-methanoazulen-3(2H)-one
- Reference substance name:
- rel-(1R,4aS,8aR)-1-isopropyl-4,7-dimethyl-1,2,4a,5,6,8a-hexahydronaphthalene
- Cas Number:
- 31983-21-8
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1R,4aS,8aR)-1-isopropyl-4,7-dimethyl-1,2,4a,5,6,8a-hexahydronaphthalene
- Reference substance name:
- 6-isopropyl-4,8a-dimethyl-1,2,3,7,8,8a-hexahydronaphthalene
- Cas Number:
- 473-14-3
- Molecular formula:
- C15H24
- IUPAC Name:
- 6-isopropyl-4,8a-dimethyl-1,2,3,7,8,8a-hexahydronaphthalene
- Reference substance name:
- rel-(4R,4aR)-4,4a-dimethyl-6-(prop-1-en-2-yl)-1,2,3,4,4a,7-hexahydronaphthalene
- Molecular formula:
- C15H22
- IUPAC Name:
- rel-(4R,4aR)-4,4a-dimethyl-6-(prop-1-en-2-yl)-1,2,3,4,4a,7-hexahydronaphthalene
- Reference substance name:
- rel-(1R,8aR)-1-isopropyl-4,7-dimethyl-1,2,3,5,6,8a-hexahydronaphthalene
- Cas Number:
- 317819-82-2
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1R,8aR)-1-isopropyl-4,7-dimethyl-1,2,3,5,6,8a-hexahydronaphthalene
- Reference substance name:
- Likely sesquiterpine, MW 202
- Molecular formula:
- C15H22
- IUPAC Name:
- Likely sesquiterpine, MW 202
- Reference substance name:
- Likely acetylated sesquiterpenes and acetylated sesquiterpene alcohols
- IUPAC Name:
- Likely acetylated sesquiterpenes and acetylated sesquiterpene alcohols
- Reference substance name:
- Likely oxygenated sesquiterpenes
- IUPAC Name:
- Likely oxygenated sesquiterpenes
- Reference substance name:
- Unknown constituent, MW 260
- IUPAC Name:
- Unknown constituent, MW 260
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Constituent 13
Constituent 14
Constituent 15
Constituent 16
Constituent 17
- Specific details on test material used for the study:
- Identification: Vetyveryl Acetate
Description: yellow liquid
Batch number: 9000317035
Expiry date: March 25, 2003
Storage conditions: In a refrigerator (2 - 6 °C)
Safety precautions: Gloves, goggles and face mask were sufficient to assure personnel health and safety
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test system: Rat, HanIbm: WIST (SPF)
Rationale: Recognized by the international guidelines as a recommended test system
Source: RCC Ltd, Biotechnology & Animal Breeding Division, CH-4414 Füllinsdorf, Switzerland
Number of animals per group: 3 females or 3 males
Total number of animals: 3 females, 3 males
Age when treated: Females: 10 weeks; Males: 8 weeks
Identification: By unique cage number and corresponding colour-coded spots on the tail
Acclimatization: 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 mg/kg body weight basis by oral gavage following fasting for approximately 16.5 to 17.5 hours, but with free access to water. Food was provided again approximately 3 hours after dosing.
- Doses:
- Dose / kg bosy weight: 2000 mg
Application volume / kg body weight: 10 ml
Rationale: Oral administration was used as this is one possible route of human exposure during manufacture, handling and use of the test article. - No. of animals per sex per dose:
- 3 aminals per dose
- Control animals:
- not specified
- Details on study design:
- Observations
Mortality / Viability: Four times during test day 1 and once daily during days 2 - 15.
Body weights: On test dat 1 (pre-administration), 8 and 15
Clinical signs: Each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2 - 15.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death ocurred during the study
- Clinical signs:
- other: No clinial signs were observed during the stuy period
- Gross pathology:
- No marcoscopic findings were observed at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of Vetyveryl Acetate after signle oral administraion to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred.
LD50 : greater than 2000 mg/kg body weight
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