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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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although conducted prior to current protocol or GLP requirements, the study conformed to recognized protocols current at the time.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Principles of method if other than guideline:
Performed prior to current protocol or GLP requirements but by a method acceptable at the time.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material: 5-(Sodiosulfo)isophthalic Acid
- Appearance/Physical form: powder
- Formula Weight: 268 g/mol
- Molecular Formula: C8H6O7S-1Na
- Purity: >92% (assay)
- Impurities: sodium sulfate,- Lot/batch No.: ARK BA103-81; X-17007-226

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Male and female rats were given an aqueous solution of the test substance by gavage.
Doses:
3200 mg/kg bwt
No. of animals per sex per dose:
4
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 200 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 3 200 mg/kg bw
Mortality:
One of four male and one of four female rats died.
Clinical signs:
Clinical signs included prostration, diarrhea, rough hair coat, depressed appetite, and slight to moderate weakness post dosing.

Applicant's summary and conclusion

Conclusions:
The LD50 value of the test substance in male and female rats was greater than 3200 mg/kg bwt.