Dibenzylbenzene, ar-methyl derivative

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 T03-021

Deviations:

yes

Remarks:

the age of the animals at study initiation or the individual results (bodyweight, clinical signs) were not reported.

GLP compliance:

yes

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: Charles River France (76410, Saint-Aubin-lès-Elbeuf)
- Age: 6 weeks
- Weight at study initiation: 184 g (males) and 153 g (females)
- Number of animals per dose group: 5 males + 5 females
- Controls: 5 males + 5 females received the same volume of sterile distilled water.
- Fasting period before study (with water): yes, 18 to 19 hours before treatment
- Housing: 5/polycarbonate cage (40.8 cm x 33.3 cm x 15 cm)
- Diet (e.g. ad libitum): rodent diet ad libitum
- Water (e. g. ad libitum): ad libitum in 500-800 mL feeding bottle
- Acclimatation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 50+/-20
- Air changes (per hr): 15
- Photoperiod (hrs dark/hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Dosage-volume: 10 mL/kg

Doses:

10360 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

EXAMINATIONS:
- Post dose observation period: 14 days
- Clinical signs: examined at least once a day
- Mortality: recorded at least once a day
- Body weight: measured just before administration and then on days 6 and 14.
- Necropsy:
. macroscopic examination of the main organs such as digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities.
. microscopic examination: no

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 10 360 mg/kg bw

Mortality:

No deaths were recorded.

Clinical signs:

other: A piloerection was observed in all the treated animals approximately 4.5 hours after administration. However, it was no more observed the following day.

Gross pathology:

No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD0 was > 10360 mg/kg.

Executive summary:

The acute oral toxicity of Dibenzylbenzene, ar-methyl derivative was tested on male and female Sprague-dawley rats at the limit dose of 10360 mg/kg. No mortality was observed during the exposure and 14 days following the exposure. Piloerection was noted in all the treated animals, 4.5 hours after the administration of Dibenzylbenzene, ar-methyl derivative but was no more observed the following day. No differences in body weight gain or in macroscopic findings were observed.

Under these experimental conditions, the LD0 was consider to be > 10360 mg/kg.