Potassium 4-acetoacetylaminobenzenesulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

March 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

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:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

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 LZ699.00
- 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
- Colour: white to yellowish
- Odour: Odourless

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Nossan S.r.I., Correzzana (MI), Italy
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 176-200 g
- Housing: individually in polycarbonate cages
- Diet (e.g. ad libitum): commercially available laboratory rodent diet (Altromin MT, A. Rieper S.p.A., Bolzano, Italy)
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): artificial cycle of 12 hours light and 12 hours dark each day

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred following dosing.

Clinical signs:

other: No clinical signs were observed, with the exception of an abrasion, which became a scab, observed in a single female animal on Days 2, 3 and 4. This sign was not considered to be related to treatment with the test substance.

Other findings:

No abnormalities were found on necropsy of animals on termination of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermall LD50 on Sprague-Dawley rats was found to be > 2000 m/kg (males/females).

Executive summary:

The acute dermal toxicity on Sprague-Dawley rats was assessed in a study following OECD testing method no. 403. A limit test with a dose of 5000 mg/kg bw was performed. Neither mortality nor signs of toxicity were observed in the main study. In conclusion, the acute oral LD50 on rats was determined to be > 2000 mg/kg.