1,1'-(1,1,2,2-tetramethylethylene)dibenzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1993-02-04 to 1993-02-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

84/449/EEC

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-(1,1,2,2-tetramethylethylene)dibenzene

EC Number:

217-568-2

EC Name:

1,1'-(1,1,2,2-tetramethylethylene)dibenzene

Cas Number:

1889-67-4

Molecular formula:

C18H22

IUPAC Name:

(2,3-dimethyl-3-phenylbutan-2-yl)benzene

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: males: 249 - 299 g; females: 196 - 191 g
- Fasting period before study: yes, 18 h before treatment
- Acclimation period: at least one week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: standard vehicle according to guideline

DOSAGE PREPARATION:
The test item was granulated using a mortar and pestle, subsequently weighed into a glass beaker on a Mettler tarred analytical balance and corn oil was added. Adjustment was made for the specific gravity of the vehicle. A weight/weight suspension was prepared using a magnetic stirrer. The preparation was made immediately prior to dosing.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Motality/Viability: At least three times each day
Body Weights: Test days 1 (pre-administration), 8 and 15
Clinical Signs: Each animal was examined for changes to treatment with particular attention paid to changes in behaviour, respiration, motility, body posture, motor susceptibility, skin, eyes, nose and fur. Observations (including mortality/viability) were performed four times during day 1 and once daily during days 2 - 15.
- Necropsy of survivors performed: yes, all animals.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: No clinical signs were observed during the study period.

Gross pathology:

Macroscopic post mortem examinations of the animals at termination did not reveal any abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of 1,1'-(1,1,2,2-tetramethylethylene)dibenzene in the rat after oral administration (gavage) is greater than 2000 mg/kg bw.

Executive summary:

The oral toxicity of 1,1'-(1,1,2,2-tetramethylethylene)dibenzene was assessed according to OECD guideline 401 and EU method B.1. The test item was administered to one group of 3 male and 3 female Wistar rats by oral gavage, at a single dose of 2000 mg/kg bw. No mortality occurred, no clinical signs were observed and no macroscopic abnormalities were seen at necropsy. Based on these observations, the estimated acute oral toxicity LD50 of 1,1'-(1,1,2,2-tetramethylethylene)dibenzene in rats of both sexes observed for a period of 15 days is greater than 2000 mg/kg bw.