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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
other: Annex V
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system 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:
other: 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.