Lithium dihydrogen 5-sulphonatoisophthalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Data Reported: 21 September 1979

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Justification for type of information:

Weight of Evidence: The test result is reported without adequate documentation to fully judge its reliability. However, when coupled with data from a second species, its reliability and usefulness for classification and labeling is enhanced.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Documentation insufficient to fully judge reliability.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Lithium dihydrogen 5-sulphonatoisophthalate

EC Number:

256-275-4

EC Name:

Lithium dihydrogen 5-sulphonatoisophthalate

Cas Number:

46728-75-0

Molecular formula:

C8H6O7S.Li

IUPAC Name:

lithium dihydrogen 5-sulphonatoisophthalate

Test material form:

solid: particulate/powder

Details on test material:

- Moisture content: 6.5%
- Colour: Off-white

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No information reported.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Rats were given 10% aqueous solutions of the test substance via gavage.

Doses:

Reported as: 200 - 3200 mg/kg-bw. No intermediate dose was reported but is presumed to have been 800 mg/kg with a 0 mg/kg control group; giving presumed doses of 0, 200, 800, and 3200 mg/kg-bw.

No. of animals per sex per dose:

In total, 20 animals are reported but the number of animals per dose is not reported. Given the presumed doses of 0, 200, 800, and 3200 mg/kg-bw, it is presumed there were 5 animals per dose.

Control animals:

other: Not specified but presumed yes.

Remarks:

See above discussion on doses and animals per dose.

Statistics:

Not specified.

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

approximate LD50

Effect level:

2 262 mg/kg bw

Based on:

test mat.

Mortality:

Numbers not reported. Time of death reported to be 1-2 days.

Clinical signs:

Normal to slight weakness and quite in low doses. Lethargic with diarrhea and one animal moribund in the high dose.

Body weight:

Positive weight change reported after 2 weeks.

Gross pathology:

No information reported.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The test substance is reported to have an Oral LD50 in rats of 2262 mg/kg-bw.

Executive summary:

In a non-GLP study performed in a manner similar to OECD 401, the test substance was found to have an Oral LD50 in rats of 2262 mg/kg-bw.