Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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
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

Test animals

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

Administration / exposure

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

Results and discussion

Preliminary study:
Not relevant
Effect levels
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

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 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.