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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Specific details on test material used for the study:
Not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 total
Control animals:
not specified
Details on study design:
Not specified
Statistics:
Not specified

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
One animal died receiving this dose
Clinical signs:
isolated instances of diarrhea, chromorhinorrhea, ptosis, and chromodacryorrhea
Body weight:
Not specified
Gross pathology:
At necropsy, gross observations were normal for eight animals. Necropsy of the remaining two animals revealed the following changes in either one or both animals: red and/or yellow areas in the intestines, red areas in the stomach, mottled liver, mottled spleen, mottled kidneys, dark lungs, red exudate in the anogenital area, and a large amount of blood in the bladder.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was evaluated for acute oral toxicity in rats using a limit test dose of 5000 mg/kg bw. The LD50 of the test substance was greater than this dose. According to GHS criteria for acute oral toxicity, criteria for classification for acute oral toxicity are not met.