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Diss Factsheets

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:
1999
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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
Constituent 3
Chemical structure
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
Constituent 4
Chemical structure
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
Constituent 5
Chemical structure
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
Constituent 6
Chemical structure
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
Constituent 7
Chemical structure
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
Constituent 8
Chemical structure
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
Constituent 9
Chemical structure
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
Constituent 10
Chemical structure
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
Constituent 11
Chemical structure
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
Constituent 12
Chemical structure
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
Constituent 13
Chemical structure
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
Constituent 14
Reference substance name:
Likely sesquiterpine, MW 202
Molecular formula:
C15H22
IUPAC Name:
Likely sesquiterpine, MW 202
Constituent 15
Reference substance name:
Likely acetylated sesquiterpenes and acetylated sesquiterpene alcohols
IUPAC Name:
Likely acetylated sesquiterpenes and acetylated sesquiterpene alcohols
Constituent 16
Reference substance name:
Likely oxygenated sesquiterpenes
IUPAC Name:
Likely oxygenated sesquiterpenes
Constituent 17
Reference substance name:
Unknown constituent, MW 260
IUPAC Name:
Unknown constituent, MW 260
Test material form:
liquid
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:
No clinial signs were observed during the stuy period
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age
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