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Diss Factsheets

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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted February 24, 1987
Deviations:
no
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

Constituent 1
Chemical structure
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.