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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study, however basic data of test item (purity, stability) are missing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK)
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 227-243 g (males) and 200-214 g (females)
- Fasting period before study:
- Housing: The animals were housed in groups of up to 5 by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet: ad libitum; with the exception of an overnight fast immediately before dosing
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 50-56
- Air changes (per hr): 15
- Photoperiod: 12 hours dark/light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
The volume administered to each animal was calculated according to its fasted body weight at the time of dosing.
Doses:
Based on the results of a range-finding study a group of animals was treated as follows:
Dose level: 2000 mg/kg
Concentration: 200 mg/ml
Dose volume: 10 ml/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior dosing on day 0 and on days 7 and 14. At the end of the study the animals were killed and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic carvities for examination of major organs. The appearance of any macroscopic abnormalities was recoded. No tissues were retained.
Statistics:
no data

Results and discussion

Preliminary study:
There were no daeths or clinical signs of toxicity. Based on this information, a dose level of 2000 mg/kg body weight was selected for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths
Clinical signs:
No signs of systemic toxicity were noted during the study.
Body weight:
All animals showed an expected gain in body weight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information at the tested dose Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose of the test material was found to be greater than 2000 mg/kg body weight. No symbol and risk phrase are required according to EU labelling regulations.