Benzyl benzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 January 1985 to 26 February 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The test material was probably administered, at various concentrations in peanut oil, as the technical grade material but no information was available to confirm purity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Standard limit test according to OECD 401

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl benzoate

EC Number:

204-402-9

EC Name:

Benzyl benzoate

Cas Number:

120-51-4

Molecular formula:

C14H12O2

IUPAC Name:

benzyl benzoate

Test material form:

other: clear colourless liquid

Details on test material:

- Name of test material (as cited in study report): benzylbenzoat H&R or benzylbenzoate
- clear, colourless liquid
- Analytical purity: no data
- Lot/batch No.: 4128806 B
- Expiration date of the lot/batch: no data

stored at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A Tuck & Sons Ltd, Essex, UK
- Age at study initiation: 4-6 weeks old
- Weight at study initiation: 119-148g males and 118-148g females
- Fasting period before study: yes, overnight unti 2 hours aftre dosing
- Housing: groups of five by se in polypropylene cages
- Diet (e.g. ad libitum):Rat & Mouse Expanded No.1, supplied by SDS Witham, Essex; ad libitum
- Water (e.g. ad libitum): ad libitum access to tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 40-55%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 31 January 1985 To: 26 February 1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: For range finding test - 20, 100, 200, 300 and 400 mg/ml and for the main study 400 mg/ml
- Amount of vehicle (if gavage): dose volume was 5 mL/kg bw
- Justification for choice of vehicle: arachis oil used basd on suitability during range-finding investigations

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

DOSAGE PREPARATION (if unusual): prepared freshly for each dose administration

Doses:

range-finder: 100, 500, 1000, 1500 and 2000 mg/kg bw

main study: 2000 mg/kg bw

No. of animals per sex per dose:

2 in range finder; 5 in main study

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequent hourly observations on day of dosing; daily checks thereafter; bodyweights recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

Not required

Results and discussion

Preliminary study:

The range finding investigation revealed no mortalities in the dose range 100 to 2000 mg/kg bw. Hunched posture, lethargy, decreased respiratory rate and piloerection were frequently observed in the range-finder groups but the signs and severity of clinical response showed no treatment relationship. Recovery from systemic effects was complete within three days for all groups.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths at the limit dose

Mortality:

There were no deaths in the main study, following dosing at 2000 mg/kg bw.

Clinical signs:

other: Hunched posture, lethargy, piloerection, ptosis and a decreased respiratory rate were commonly observed shortly after dosing with infrequent cases of body tremors also noted. Recovery from all signs was complete by Day 4.

Gross pathology:

Macroscopic examination at necropsy revealed congested lungs for one rat (normally an agonal response) and pale areas on the gastric glandular region for one rat. No other macroscopic abnormalities were apparent.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 for benzylbenzoate was greater than 2000 mg/kg bw in rats.

Executive summary:

In a standard acute oral study in rats, in accordance with test guideline OECD 401, groups of five male and female rats were dosed at 2000 mg/kg bw. Clinical signs including hunched posture, decreased respiratory rate, lethargy, ptosis and pilo-erection were apparent shortly after dosing but recovered within 4 days. The acute oral median lethal dose for benzylbenzoate was greater than 2000 mg/kg bw in rats.