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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Toxicology and carcinogenesis of benzyl acetate (CAS NO. 140-11-4) in F344/N rats and B6C3F1 mice (gavage studies)
Author:
Abdo, K. et al
Year:
1986
Bibliographic source:
National Toxicology Program, Publication No. 86-2506, USA, 1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
Male and female F344/N rats were obtained from Frederick Cancer Research Center and observed for 7 days before the test began. Animals were approximately 5 weeks old when placed on study, Groups of five rats of each sex were administered a single dose of benzyl acetate (250, 500, 1,000, 2,000, or 4,000 mg/ kg body weight) in corn oil by gavage. No controls were used. All animals were examined twice daily for clinical signs and mortality during the 15-day observation period. Animals were housed five per cage and received water and feed ad libitum during the observation period. Necropsies were not performed.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzyl Acetate
- Physical state: water-white liquid with a pear-like odor
- Other:
Melting Point: -5100C
Boiling Point: 213 C
Vapor Pressure: 1.99 mm Hg at 60'C
Density: 1.05
Refractive Index: 1.4998
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzyl Acetate
- Physical state: water-white liquid with a pear-like odor
- Other:
Melting Point: -5100C
Boiling Point: 213 C
Vapor Pressure: 1.99 mm Hg at 60'C
Density: 1.05
Refractive Index: 1.4998

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Frederick Cancer Research Center Frederick. M D
- Age at study initiation: 5 weeks
- Housing: Bedding: Beta-Chips heat treated hardwood chips
Cages: Polycarbonate
Cage filters: Spun-bonded polyester filters

- Diet (e.g. ad libitum): Wayne Lab-Blox Allied Mills. ad libitum
- Water (e.g. ad libitum): Tap water supplied through automatic watering system. ad libitum
- Acclimation period: 1 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 40-60
- Air changes (per hr): 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Male and female rats: 250, 500, 1,000, 2,000 or 4,000 mg/kg body weight in corn oil
- Amount of vehicle (if gavage): 5 ml/kg for rat
- Justification for choice of vehicle: No data

MAXIMUM DOSE VOLUME APPLIED: 4,000 mg/kg body weigh


Doses:
Male and female rats: 250, 500, 1,000, 2,000 or 4,000 mg/kg body weight in corn oil
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Necropsy of survivors performed: no
- Other examinations performed: Observed twice daily for mortality and clinical signs
Statistics:
No data

Results and discussion

Preliminary study:
No applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals that received benzyl acetate at 4,000 mg/ kg body weight were inactive within 2 hours after dosing, and 4/5 males and 2/5 females in these groups died (all on day 2).
Clinical signs:
All animals that received benzyl acetate at 4,000 mg/ kg body weight were inactive within 2 hours after dosing. No other compound-related clinical signs were observed
Body weight:
No data
Gross pathology:
No data
Other findings:
No further data

Any other information on results incl. tables

No further data

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 for Benzyl acetate was found to be above 2000 mg/kg body weight in rats. According to Regulation (EC) No. 1272/2008, no classification is warranted.
Executive summary:

Male and female F344/N rats were obtained from Frederick Cancer Research Center and observed for 7 days before the test began. Animals were approximately 5 weeks old when placed on study, Groups of five rats of each sex were administered a single dose of benzyl acetate (250, 500, 1,000, 2,000, or 4,000 mg/ kg body weight) in corn oil by gavage. No controls were used. All animals were examined twice daily for clinical signs and mortality during the 15-day observation period. Animals were housed five per cage and received water and feed ad libitum during the observation period. Necropsies were not performed. The LD50 for Benzyl acetate was found to be above 2000 mg/kg body weight in rats. According to Regulation (EC) No. 1272/2008, no classification is warranted.