Dibenzylbenzene, ar-methyl derivative

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

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 03-033

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:

Dibenzylbenzene, ar-methyl derivative

EC Number:

258-649-2

EC Name:

Dibenzylbenzene, ar-methyl derivative

Cas Number:

53585-53-8

Molecular formula:

C21H20

IUPAC Name:

dibenzylbenzene, ar-methyl derivative

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 360x 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
- Photoperiod (hrs dark/hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 225 cm2 (15 x15 cm) on the back
- % coverage: not reported
- Type of wrap if used: adhesive

REMOVAL OF TEST SUBSTANCE
-Washing (if done): skin is wiped with a gauze pad, rinsed with tepid water and dried with paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1,98 ml/kg
- Concentration (if solution) : 1.01 g/mL

Duration of exposure:

24

Doses:

2000 mg/kg

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: dermal reactions

Statistics:

Student's test

Results and discussion

Preliminary study:

No mortality was observed at any dose level.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed.

Clinical signs:

other: No observed effects.

Gross pathology:

No abnormalities were revealed at necropsy.

Other findings:

CUTANEOUS FINDINGS:
In all the treated animals, a slight irritation was noted (grade 1 erythema). It disappeared on the second week. A slight cutaneous dryness was
observed between day 5 and day 10. A pelling occured between day 6 and day 11. No oedema was found at any moment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of the substance was found to be greater than 2000 mg/kg/bw. Therefore, no classification for acute dermal toxicity is required.

Executive summary:

The acute dermal toxicity of Dibenzylbenzene, ar-methyl derivative was determined in rabbits in a limit test (2000 mg/kg bw) performed according the French Guideline AFNOR NF T03 -333. The mortality and general behavior of the animals were observed for a period of 14 days after the administration of the 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.

The dermal LD50 of the substance was found to be greater than 2000 mg/kg bw; therefore, no classification for acute dermal toxicity should be required.