Potassium 4-acetoacetylaminobenzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March - April 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: guideline study, non-GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

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)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Substance name: P0363
- Storage: Keep container tightly closed. Store in dry, cool and well-ventilated place. Do not store in heat or direct sunlight.
- Aggregate state/appearance: solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin and Kingman, Grimston, Aldbrough, Nr. Hull, HUll 4QE
- Age at study initiation: no data
- Weight at study initiation: 125-225 g
- Fasting period before study: overnight before treatment
- Housing: gang housing in groups of 2 or 5 by sex as appropriate in grid floor polypropylene boxes
- Diet (e.g. ad libitum): Rat and Mouse No. 1 Expanded Diet, BP Nutrition (U.K.) Ltd., Witham, Essex
- Water (e.g. ad libitum): tap water
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 19 - 25°C
- Photoperiod (hrs dark / hrs light): natural lighting conditions

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

- Pre-test: 10, 50, 500, 5'000 and 15'000 mg/kg
- Main study: 5000 mg/kg

No. of animals per sex per dose:

- Pre-test: 1 male / 1 female per dose group
- Main study: 5 males / 5 females

Control animals:

no

Results and discussion

Preliminary study:

100% mortality was observed at 15'000 mg/kg in the pre-test only.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed in main study.

Clinical signs:

other: None reported.

Gross pathology:

None reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 on Wistar rats was found to be > 5000 m/kg (males/females).

Executive summary:

The acute oral toxicity on Wistar rats was assessed in a study equivalent or similar to OECD testing method no. 401. A range-finding test with reduced number of animals and dose groups of 10-15'000 mg/kg was performed, followed by the main study with a limit dose of 5000 mg/kg bw.

Neither mortality nor signs of toxicity were observed in the main study. In conclusion, the acute oral LD50 on Wistar rats was determined to be > 5000 mg/kg.