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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Test species/strain/quality: Rat/Wistar/Crl:WI (Han)
Reason for selection of the test species: Rats were selected since this rodent species is recommended in the respective test guidelines. Wistar rats were selected since there is extensive experience available in the laboratory with this strain of rats.
Age on day 0: Young adult animals (female animals approx. 10 weeks)
Sex: As suggested by the OECD guideline nulliparous and non-pregnant female animals were used for the test, because there is no indication that male animals are likely to be more sensitive to the acute effects of the test item.
Supplier: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfed, Germany.
Arrival in the testing facility: Acclimatization period of at least 5 days before the beginning of the experimental phase: during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
Identification: Individual identification by cage cards and tail marking.
Body weight on day 0: Animals of comparable weight (+/- 20% of the mean weight)
Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 22°C ± 3°C for temperature and of 30-70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Route of administration: Single oral administration by gavage
Fasting period: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
Time of day of administration: In the morning
Observation period: 14 days
Doses:
2000 mg/kg/bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
By request of the sponsor a starting dose of 2000 mg/kg/bw was chosen in the first step with 3 female animals. Because no mortality occurred in the first step, 2000 mg/kg/bw were administered to another group of 3 females animals in the second step.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs were observed during clinical examination.
Body weight:
The mean body weight of the test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material was found to be > 2000 mg/kg bodyweight. The test substance is not classified as an acute oral toxin.
Executive summary:

The acute oral toxicity of the test substance to Wistar rats was determined in accordance with the OECD Guideline for Testing of Chemicals 423. The rats were exposed to a dose of 2000 mg/kg bw of the test substance via oral gavage route. The observation period was 14 days. The acute oral median lethal dose (LD50) of the test material was found to be > 2000 mg/kg bodyweight. The test substance is not classified as an acute oral toxin.