Vetiveria zizanioides, ext., acetylated

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:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Test guideline 2

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

Test material information

Constituent 1

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

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

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

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

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

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

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

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

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

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

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

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

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:

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