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Description of key information

Several studies are available for Acute oral, dermal and inhalation toxicity. The studies were conducted using rats, mice and rabbits as the test species. Two of the Acute Oral Toxicity studies conformed to OECD Guideline 401. The Acute Inhalation Toxicity Study conformed to OECD Guideline 403.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Reason / purpose:
reference to same study
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
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
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
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
Preliminary study:
No applicable
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

No further data

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Older guideline-comparable studies are available in the rat and mouse, methodology is acceptable for hazard evaluation and classification purposes

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 Octover, 1996 - 22 November, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
A single dose level of 0.766 mg/I of air was used as this was the maximum attainable concentration of vapour at ambient temperature.
Principles of method if other than guideline:
The acute inhalation toxicity of benzyl acetate was assessed by exposing a group of rats, for a period of 4 hours, to the vapour of the test substance at a concentration of 0.766 mg/I of air. This was the maximum attainable concentration of vapour at ambient temperature. A further group, acting as a control, was exposed to clean air only.
GLP compliance:
yes
Test type:
traditional method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzyl Acetate
- Substance type: intermediate
- Physical state: Clear colourless liquid
- Analytical purity: >98%
- Expiration date of the lot/batch: 9 October, 1997
- Storage condition of test material: Room temperature and in the dark
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Manston Road, Margate, Kent, England
- Age at study initiation: between 8 weeks and 12 weeks old
- Weight at study initiation: 198 - 273 g
- Fasting period before study: no
- Housing: The holding cages (size 35 cm x 53 cm x 25 cm height) were made of stainless steel sheet and wire mesh and were suspended on a movable rack.
- Diet (e.g. ad libitum): measured amounts
- Water (e.g. ad libitum): measured amounts
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hous light and 12 hours dark

IN-LIFE DATES: From: 3 November, 1996 To: 22 November, 1996
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: whole-body exposure chambers
- Exposure chamber volume: 120 Iitres
- Method of holding animals in test chamber: The rats were held for exposure in stainless steel mesh exposure cage subdivided to provide individual compartments for the rats.
- Source and rate of air: A supply of clean dried air was connected to the vapour generator and the supply pressure was adjusted to give a flow rate of 25 Iitres per minute measured at the generator outlet tube.
- Method of conditioning air: air supplied to the generator was dried, filtered and oil free.
- System of generating particulates/aerosols: The atmosphere generator, shown in Figure 1, was designed to produce and maintain an atmosphere containing vapour by evaporation of the test substance from a sintered glass disc with a countercurrent of air.
- Treatment of exhaust air: Each chamber was installed in a large fume cupboard exhausting through an absolute filter.
- Temperature, humidity, pressure in air chamber: 23°C± 5°C, 48 ± 3%

TEST ATMOSPHERE
- Brief description of analytical method used: Gas chromatography: The samples from the bubblers were placed in appropriately labelled scintillation vials prior to injection onto the GC column.
Column: DB-1701fusedsilicaWCOT(J&W), 15m x 0.53mm, dF 111m. Helium carrier at 5.1mllmin. Temperature: l30°C
Detector: FlO, Range O. Temperature: 280°C.
Flow rates: hydrogen, 40 mllmin; air 400 ml/min. Retention Time Approximately 2.65 minutes Injection Volume 1 Ill. Temperature: 180°C
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle (if applicable): air
- Concentration of test material in vehicle (if applicable): 0.766 mg/I of air (nominal 5.4 mg/L)


Analytical verification of test atmosphere concentrations:
yes
Remarks:
Five air samples were taken from the chamber during each exposure and the concentration of Benzyl acetate in the chamber air was determined by chemical analysis.
Duration of exposure:
ca. 4 h
Concentrations:
0.766 mg/I of air. This was the maximum attainable concentration of vapour at ambient temperature.
No. of animals per sex per dose:
5 rats/sex/dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The clinical signs were recorded at the end of the chamber equilibration period, at 0.25, 0.5 and 1.0 hours and then at hourly intervals during the exposure. During the observation period, the clinical signs were recorded once in the morning and then as necessary following a later check for clinical signs. All rats were weighed daily from the day of delivery to the Huntingdon Life Sciences until the end of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: The amount of food and water consumed by each cage of rats was measured daily from the day of arrival. The daily mean intakes of food and water for each rat were calculated from the recorded data.
All rats were subjected to a detailed macroscopic examination. The lungs were removed, dissected clear ofsurrounding tissue and weighed in order to calculate the lung weight to bodyweight ratio.
Statistics:
Not applicable
Preliminary study:
Not relevant
Key result
Sex:
male/female
Dose descriptor:
LCLo
Effect level:
> 0.766 mg/L air
Based on:
test mat.
Remarks:
the maximum attainable vapour concentration at ambient temperature.
Exp. duration:
4 h
Mortality:
There were no deaths following exposure to benzyl acetate.
Clinical signs:
other: All rats were normal in appearance and behaviour during exposure and during the observation period. Food and water consumption of test rats were not affected following exposure to benzyl acetate vapour.
Body weight:
Bodyweight gain for rats exposed to the vapour of benzyl acetate was similar to that of the control
rats.
Gross pathology:
There were no macroscopic findings at post mortem.
Other findings:
No additional findings

no further data

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LCLo for benzyl acetate as vapour is in excess of 0.766 mg/l, the maximum attainable vapour concentration at ambient temperature.
Executive summary:

The acute inhalation toxicity of benzyl acetate was assessed by exposing a group of rats, for a period of 4 hours, to the vapour of the test substance at a concentration of 0.766 mg/L of air. This was the maximum attainable concentration of vapour at ambient temperature (the nominal concentration was 5.4 mg/L). A further group, acting as a control, was exposed to clean air only. Based on the results of this study, the test substance does not require classification according to Regulation EC No. 1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
766 mg/m³
Quality of whole database:
Acceptable guideline and GLP study

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was applied to 3 rabbits and their reactions observed for 14 days.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Benzyl Acetate
- Lot/batch No.: RIFM HRB-03-1184
- Description: Clear colourless liquid
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No information provided
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No information provided
Duration of exposure:
No information provided
Doses:
5g/kg body weight
No. of animals per sex per dose:
3 animals used
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
No information provided
Preliminary study:
Not relevant
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg body weight
Based on:
not specified
Mortality:
No deaths observed
Clinical signs:
No abnormal clinical signs observed
Body weight:
No information provided
Gross pathology:
No information provided
Other findings:
No information provided

No information provided

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the LD50 of the test substance was determined to be greater than 5g/kg bodyweight. According to Regulation EC No. 1272/2008, the test substance does not require classification.
Executive summary:

In a study conducted by Moreno (1972), the test substance, Benzyl Acetate, was applied to 3 rabbits at a dose of 5g/kg body weight. The rabbits were observed for 14 days following application. The study resulted in an LD50 determined to be greater than 5g/kg bodyweight. According to Regulation EC No. 1272/2008, the test substance does not require classification.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Older non-guideline study, acceptable for hazard evaluation

Additional information

Acute Oral Toxicity:

In a study conducted by Abdo (1986), 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.

In a study conducted by Abdo (1986), male and female B6C3F1 mice 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 mice 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 mice. According to Regulation (EC) No. 1272/2008, no classification is warranted.

In a study conducted by Jenner (1964), oral dosages benzyl acetate were administered by intubation to the rat . Animals were observed for 2 weeks during which time the development of toxic signs was followed and time of death recorded. The acute oral LD50 was determined. The LD50 for benzyl acetate was found to be 2490 mg/kg. According to Directive 67/548/EEC, no classification is warranted. According to Regulation (EC) No. 1272/2008, no classification is warranted.

The key study was determined to be the one conducted by Abdo in 1986 as it conformed to the guidelines.

Acute Inhalation Toxicity:

The acute inhalation toxicity of benzyl acetate was assessed by exposing a group of rats, for a period of 4 hours, to the vapour of the test substance at a concentration of 0.766 mg/I of air. This was the maximum attainable concentration of vapour at ambient temperature. A further group, acting as a control, was exposed to clean air only. Based on the results of this study, the test substance does not require classification according to Regulation EC No. 1272/2008.

Acute Dermal Toxicity:

In a study conducted by Moreno (1972), the test substance, Benzyl Acetate, was applied to 3 rabbits at a dose of 5g/kg body weight. The rabbits were observed for 14 days following application. The study resulted in an LD50determined to be greater than 5g/kg bodyweight. According to Regulation EC No. 1272/2008, the test substance does not require classification.

Justification for classification or non-classification

Acute oral toxicity:

Based on the results of the key study (Abdo, 1998), the test substance does not require classification according to Regulation EC No. 1272/2008.

Acute Inhalation Toxicity:

Based on the results of the available study, the test substance does not require classification according to Regulation EC No. 1272/2008.

Acute Dermal Toxicity:

Based on the results of the available study, the test substance does not require classification according to Regulation EC No. 1272/2008.