Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
This study is included in a NONS registration and therefore has been evaluated by a relevant competent authority and is considered to be reliable.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
10 male and 10 female rats

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
10 animals per sex per dose
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 2000 mg/kg bw ; Number of animals: 10; Number of deaths: 0
Female: 2000 mg/kg bw ; Number of animals: 10; Number of deaths: 0
Clinical signs:
No deaths and no signs of toxicity were observed.
Gross pathology:
No effects on organs

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for the test item was determined to be > 2000 mg/kg b.w., the only concentration tested. No deaths and no signs of toxicity were observed.
Executive summary:

The acute oral toxicity of the test item to Crj(CD)SD rats was determined in a limit test conducted according to international guidelines. The LD50 was determined to be > 2000 mg/kg b.w., the only concentration tested. No deaths and no signs of toxicity were observed.

The study is a GLP compliant, guideline study and is acceptable with restrictions.