Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short report, no GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

pre-dates GLP regulation

Test material

Test material information

Constituent 1

Reference substance name:

94933-05-8

EC Number:

619-080-9

Cas Number:

94933-05-8

IUPAC Name:

94933-05-8

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Morton commercial rabbits, Parsonage farm, Stansted, UK
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2,44 to 2,7 kg
- Housing: single, grid floor cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum):ad lib.
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21
- Humidity (%): 48 to 62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10/ 14

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 h after instillation

SCORING SYSTEM: acc. to Draize (1949)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hr

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 hr

Score:

0

Max. score:

0

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 hr

Score:

0

Max. score:

0

Irritant / corrosive response data:

Conjunctival irritation, identified by moderate redness, slight to moderate swelling and discharge, was noted in the 3 treated animals one hour after treatment. At the 24 hour observation all 3 rabbits showed moderate redness of the conjunctival membranes. The conjunctival irritation regressed and all eyes appeared normal on day 7.
No corneal opacity or iridtal inflarnmation was noted during the study period.
The hair adjacent to the eye was stained brown by the test article.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information slight effects not sufficient for classification Criteria used for interpretation of results: EU

Conclusions:

The test material was a mild irritant to the rabbit eye.

Executive summary:

A study was performed to assess the irritant effects of the test material on the eye of the New Zealand White rabbit. The protocol was designed to meet the requirements of Annex Vof the EEC Council Directive 79/831/EEC, the Organisatfon for Economic Co-operation and Development (OECD) and the HSE Approved Code of Practice Notification of New Substances Regulations 1982.

The instillation of 100 mg of solid Brown HH 469 produced positive eye effects in the conjunctivae of the 3 animals one and 24 hours after treatment. The test article was regarded as a mild irritant to the rabbit eye.