Benzyltoluene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 14 to 28 October 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: AFNOR NF T 03-333

Deviations:

yes

Remarks:

The following parameters were missing: the age of animals at study start, the temperature, humidity and air changes during acclimation period.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzyltoluene

EC Number:

248-654-8

EC Name:

Benzyltoluene

Cas Number:

27776-01-8

Molecular formula:

C14H14

IUPAC Name:

1-benzyl-2-methylbenzene; 1-benzyl-3-methylbenzene; 1-benzyl-4-methylbenzene

Details on test material:

- Name of test material (as cited in study report): Ugilec 101
- Physical state: colourless liquid
- Storage condition of test material: bottle in aluminium

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: GWEN MEUR, France
- Age at study initiation: not reported
- Weight at study initiation: 2.5 +/- 0.1 kg
- Fasting period before study: not reported
- Housing: individually in cage of 540 x 360 x 315 mm
- Diet (e.g. ad libitum): 150 g of commercial granules given daily
- Water (e.g. ad libitum): filtered water ad libitum
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14 October To: 28 October 1981

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 225 cm2 (15 x 15 cm)
- % coverage: not reported
- Type of wrap if used: adhesive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gauze, then water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not reported
- Concentration (if solution): 0.99 g/mL



VEHICLE: No

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:daily observation and weighing on Days 1, 4, 7, 11 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: dermal reactions

Statistics:

Student's t test

Results and discussion

Preliminary study:

No mortality was observed at any dose level.

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed.

Clinical signs:

other: No treatment related clinical signs were observed. Diarrhea have been observed in 3 test substance treated animals, but also in 3 control animals.

Gross pathology:

No treatment related effect was elicited.

Other findings:

- Other observations:
Cutaneous reactions: In all treated animals, an moderate erythema (score = 2) was noted 24 hours after treatment, with oedema slight or moderate (score: 1 to 3). Oedema was reversible but not erythema.
Dryness of the skin from day 3 and skin desquamation from day 7 were also noted in most of treated animals. Those later findings persisted up to the end of experiment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The possible acute dermal toxicity of benzyl toluenes was evaluated in New-Zealand albinos rabbits. Benzyl toluenes was administered as such under occlusive binders at the dose level of 2000 mg/kg in groups of 10 rabbits (5 males and 5 females). The mortality and general behavior of the animals were observed for a period of 14 days after the administration of the test substance. No mortality was observed at the dose-level of 2000 mg/kg. The general behavior and the bodyweight of the animals were not influenced by the treatment. Under these experimental conditions, the LD₀ of benzyl toluenes administered by dermal route in the rabbits was higher than 2000 mg/kg.