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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Test was performed with dibenzyltoluene, new name: dibenzylbenzene, ar-methyl derivative

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
A piloerection was observed in all the treated animals approximately 4.5 hours after administration. However, it was no more observed the following day.
Body weight:
The body weight gain was similar in the treated and control groups.
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU and CLP-GHS
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.