Disodium [2,2'-bi-1H-indole]-3,3'-diolate

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:

weight of evidence

Study period:

9 February to 16 February 1987

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

[2,2'-bi-1H-indole]-3,3'-diol

EC Number:

229-449-2

EC Name:

[2,2'-bi-1H-indole]-3,3'-diol

Cas Number:

6537-68-4

IUPAC Name:

2,2'-biindole-3,3'-diol

Details on test material:

- Name of test material (as cited in study report): Indigo white 50% paste
- Molecular formula (if other than submission substance): C16H12N2O2
- Molecular weight (if other than submission substance): 264.29
- Smiles notation (if other than submission substance): C4=CC=C2C(=C4)C(O)=C(C1=C(O)C3=C(N1)C=CC=C3)N2
- InChl (if other than submission substance): InChI=1S/C16H12N2O2/c19-15-9-5-1-3-7-11(9)17-13(15)14-16(20)10-6-2-4-8-12(10)18-14/h1-8,17-20H
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: preparation
- Physical state: black paste
- Lot/batch No.: Mix 39
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.86 kg
- Housing: single
- Diet: Rabbit maintenance diet, Preston Farmers Ltd. UK ad libitum
- Water: tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 19
- Humidity (%): 45 to 50
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 9 To: 16. February 1987

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

1 hour

Observation period (in vivo):

1, 24, 48, 72 hours + 7 days

Number of animals or in vitro replicates:

1

Details on study design:

SCORING SYSTEM: see Tab. 1 + 2

Index
0-10 non irritating
11-25 slightly irritating
26-56 moderately irritating
57-110 severely irritating

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #1

Time point:

other: 1 h

Score:

19

Max. score:

110

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #1

Time point:

other: 24 h

Score:

85

Max. score:

110

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #1

Time point:

other: 48 h

Score:

66

Max. score:

110

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal #1

Time point:

other: 72 h

Score:

41

Max. score:

110

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

A dulling of the normal lustre of the corneal surface was noted one hour after treatment. Opalescent opacity was noted at subsequent 24, 48, and 72-hour observations. The cornea appeared normal on day 7.
Iridal inflammation was noted one hour after treatment and subsequent 24, 48, and 72-hour observations. The iris was normal on day 7.
Moderate conjunctival irritation was noted one hour after treatment, which increased to severe conjunctivitis at subsequent 24 and 48-hour observations. The conjunctival irritation egressed to minimal at the 72-hour observation. No conjunctival irritation was noted on day 7.

Other effects:

Areas of blue staining of the iris and conjunctival membranes were noted during the study

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US FDA

Conclusions:

The test item "indigo white 50% paste" is irritating to eyes. This is due to the alkaline ingredient in the preparation.