Potassium 4-acetoacetylaminobenzenesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Buxted Rabbit Co. Ltd., Great ToteaseFarm, Buxted, Sussex, UK
- Age at study initiation: no data
- Weight at study initiation: 2.2-3.0 kg
- Housing: individually in grid floor cages
- Diet (e.g. ad libitum): Standard Rabbit Diet from B.P. Nutrition U.K. Ltd., Witham, Essex
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ambient temperature
- Humidity (%): ambient humidity

Test system

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g test item

Duration of treatment / exposure:

4 hours

Observation period:

24 and 48 hours after treatment

Number of animals:

6 female rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 48 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 48 hors

Score:

0

Max. score:

0

Irritant / corrosive response data:

The primary irritation index of test article was 0.14 (taking into account the 4 hour-reading with a score of 1 in 1/6 animals). The test article is therefore regarded as mild irritant, not requiring any classification. The structure of the tissue at the contact site was not destroyed within 24 hours of application in any of the 6 animals and the test article is therefore considered non-corrosive, too.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was found to be non-irritating to rabbit skin.

Executive summary:

A study was performed to determine the primary skin irritation index and corrosive effects of the test item in the New Zealand White rabbit. The study design was based on OECD Guidelines No. 404. Six female rabbits were tested and 0.5 ml test substance applied undiluted onto the clipped skin area of the animals. A single 4 -hour application produced a primary irritation index of 0.14. The test item was classified as a non-irritant to rabbit skin. No corrosive effects were noted.