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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
No clinical signs were observed during the study period.
Body weight:
The body weight gain shown by the animals over the study period was considered similar to that expected of normal untreated animals of the same age and strain, although low body weight gain was noted in two females over the second week.
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.