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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: Guideline study with GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000
Reference Type:
other company data
Title:
Unnamed
Year:
1997
Reference Type:
other: monograph provided by ECHA
Title:
Endpoint record:Acute toxicity oral
Author:
ECHA
Year:
2010
Bibliographic source:
Document from ECHA

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Principles of method if other than guideline:
There is no need to add in this field.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
75 - 95% (typical 88%, verified by UV/visible spectrum, Infrared (IR) spectrum, Nuclear Magnetic Resonance (NMR), and Mass spectrum.)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Nothing to add in this field.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
2000 mg/kg test substance in arachis oil suspension administered by oral (gavage).
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
limit test
Statistics:
no data

Results and discussion

Preliminary study:
Nothing to add in this field.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Limit test
Mortality:
no death
Clinical signs:
No signs of systemic toxicty were observed during the observation period.
Body weight:
All animals showed expected gain in bodyweight.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Nothing to add in this field.

Any other information on results incl. tables

The test chemical was of very low acute oral toxicity in rats.

Mortality: No deaths were recorded.

Clinical observations: No clinical signs of toxicity were noted.

Morphological findings: No abnormalities were noted at necropsy.

Comment: All animals showed expected gain in bodyweight.

LD50: >2 000 mg/kg

Result: The test chemical was of very low acute oral toxicity in rats.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test material was considered as a nontoxic substance via acute oral toxicity study in rats.
Executive summary:

According to OECD TG 401, the acute oral toxicity was well investigated and the results indicated the test material has very low toxicity in rats. OECD TG 401 was deleted in 2002 due to animal welfare reasons, however, the validity of the results which accomplished under TG 401 should be confirmed.