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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication/ study report which meets basic scientific principles.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Carciogenesis Studies of Food Grade Geranyl Acetate (71% Geranyl Acetate, 29% Citronellyl Acetate) (CAS No. 105-87-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
Author:
US National Institutes of Health
Year:
1987
Bibliographic source:
National Toxicology Program - Technical Report Series No. 252

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Specifications for the Conduct of Studies to Evaluate the Toxic and Carcinogenic Potential of Chemical, Biological, and Physical Agents in Laboratory Animals for the National Toxicology Program (NTP)
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Citronellyl acetate
EC Number:
205-775-0
EC Name:
Citronellyl acetate
Cas Number:
150-84-5
Molecular formula:
C12H22O2
IUPAC Name:
3,7-dimethyloct-6-en-1-yl acetate
Constituent 2
Chemical structure
Reference substance name:
Geranyl acetate
EC Number:
203-341-5
EC Name:
Geranyl acetate
Cas Number:
105-87-3
Molecular formula:
C12H20O2
IUPAC Name:
3,7-dimethylocta-2,6-dien-1-yl acetate (E)-
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): food-grade geranyl acetate
- Composition of test material: 71% geranyl acetate (CAS 105-87-3) and 29% citronellyl acetate (CAS 150-84-5) was reported for the lot used for chronic studies. No accurate determination of the content of these two components was made for the lot used in the subacute and subchronic studies.
- Lot No.: 70201 (Elan Chemical Co, Newark, NJ)
- Storage condition of test material: in the dark at 5°C

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Portage, MI
- Age at study initiation: 5 weeks
- Housing: 5/cage
- Diet and water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 40 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 days
Frequency of treatment:
once daily
Doses / concentrations
Remarks:
Doses / Concentrations:
62, 125, 250, 500, 1000 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
BODY WEIGHT: Yes
- Time schedule for examinations: weekly

OBSERVATION OF MORTALITY: Yes
- Time schedule: twice daily
Sacrifice and pathology:
NECROPSY: Yes

Results and discussion

Results of examinations

Details on results:
CLINICAL SIGNS AND MORTALITY:
- 1000 mg/kg bw: rats showed a reduction in activity from day 2 to day 4 after treatment
- all animals survived

BODY WEIGHT AND WEIGHT GAIN: no adverse effects on weight gains by dosed and control groups

NECROPSY: no compound-related effects

Effect levels

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No mortality as well as no other toxic effects were noted

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

The reported 14-day study was performed as range finding study for a 13-week 
study. (-> 7.5.1 NTP1987.Repeated dose toxicity: oral rat 13w)

Applicant's summary and conclusion