Potassium 4-acetoacetylaminobenzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Italia S.p.A., (Como), Italy
- Age at study initiation: 9-11 weeks
- Weight at study initiation: ca. 2 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): anti-biotic free pelleted laboratory diet (Altromin MSK, A. Rieper, Bolzano, Italy)
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21°C
- Humidity (%): 45-65%
- Photoperiod (hrs dark / hrs light): Artificial lighting by fluorescent tubes was set to a 24 hour cycle of 12 hours light / 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 g test item

Duration of treatment / exposure:

see below

Observation period (in vivo):

1, 24, 48 and 72 hours after dosing

Number of animals or in vitro replicates:

3 male rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

No reaction was observed in the treated eyes of any of the three animals at examinations performed approximately I, 24, 48 and 72 hour after dosing.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Th test item was found to be non-irritating to the rabbit eyes.

Executive summary:

A study was performed to determine the primary eye irritation index and corrosive effects of the test item in the New Zealand White rabbit. The study design was based on OECD Guidelines No. 405. Three male rabbits were tested and 0.1 g test substance applied undiluted into the right eye of the animals. No reaction was observed in the treated eyes of any of the three animals at examinations performed approximately 1, 24, 48 and 72 hour after dosing.. The test item was classified as a non-irritant to rabbit eyes.