Tetrasodium 4-amino-6-[[2,5-dimethoxy-4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-5-hydroxy-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 to 28 May 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Federal Register 38, No 187

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Federal Register 38, No 187

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Blue 203

IUPAC Name:

Reactive Blue 203

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test item: Reactive Blue 203

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.8 to 2.2 kg
- Housing: single
- Diet (e.g. ad libitum): ERKA Z-6000
- Water (e.g. ad libitum): tap water
- Acclimation period: NA


IN-LIFE DATES: From: 25. May To: 28. May 1982

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg pasted with 1 drop physiological saline solution

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

The test item was applied to the left eye of each rabbit. The contra-lateral eye surved as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 to 72 hours

Score:

0

Max. score:

4

Other effects:

up to 48 h the nictitating membranes were blueish discoloured

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification according to EC: not irritating

Executive summary:

A group of 6 New Zealand White rabbit, weighing 1.8 – 2.2 kg, was used for this study.

A 100 mg portion of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls.

The eyes were examined at 1, 7, 24, 48, and 72 hours following instillation of the test material into the eyes. The readings of the eyes were made in accordance with the Draize technique for scoring ocular lesions.

No signs for eye irritating properties were observed throughout the study; up to 48 h the nictitating membranes were blueish discoloured.