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Toxicological information

Eye irritation

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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

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

Resultsopen allclose all
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
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
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
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.