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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(February, 1987)
GLP compliance:
yes
Remarks:
Research & Consulting Company AG, CH-4452 Itingen, Switzerland

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
EC Number:
248-421-0
EC Name:
Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
Cas Number:
27344-41-8
Molecular formula:
C28H22O6S2.2Na
IUPAC Name:
disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)
Details on test material:
- Name of test material (as cited in study report): FAT 65029/G
- Physical state: solid, yellow
- Analytical purity: 87%
- Impurities (identity and concentrations): 10 % NaCl, 3 % H2O
- Lot/batch No.: EN 372 980
- Storage condition of test material: room temperature, light protected

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wolferstrasse 4, CH-4414 Fullinsdorf, Switzerland
- Age at study initiation: males: 14 weeks, female: 14 weeks
- Weight at study initiation: males: 2.4 - 2.5 kg, female: 2.6 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

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 g / animal
Duration of treatment / exposure:
single treatment, eyes not washed out
Observation period (in vivo):
1, 24, 48, 72 hours, 7, 14 and 21 days
Number of animals or in vitro replicates:
2 males, 1 female
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and a Varta Cliptrix diagnostic-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.4
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days (in two of three animals)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.55
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
Generally slight diffuse opacity of the cornea was observed in all animals within 1 hour to 72 hours or 14 days after test article treatment. In addition blood vessels on the sclera were visible within 1 hour to 7 or 21 days after treatment.
No corrosion of the cornea was observed at any of the measuring intervals.
Other effects:
A slight yellowish staining of the lidhairs of the treated eyes by pigment or coloring of the test article was observed (at 1 hour reading).
No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred up to 21 days.

Any other information on results incl. tables

Individual Scores:

 

 

 

 

Conjunctivae

animal no. / sex

time after application

cornea

iris

Redness

Chemosis

25 / male

1 hour

1

0

1

2

24 hours

1

0

2

2

48 hours

1

0

2

1

72 hours

1

0

2

1

7 days

1

0

1

0

14 days

1

0

1

1

21 days

0

0

1

0

26 / male

1 hour

1

0

2

2

24 hours

1

0

2

2

48 hours

1

0

2

1

72 hours

1

0

2

1

7 days

0

0

1

0

14 days

0

0

0

1

21 days

0

0

0

0

27 / female

1 hour

3

0

2

2

24 hours

3

1

2

3

48 hours

2

1

2

2

72 hours

2

1

2

1

7 days

2

1

2

1

14 days

1

0

1

1

21 days

0

0

1

0

25

mean 24-72 h

1.0

0.0

2.0

1.3

26

1.0

0.0

2.0

1.3

27

2.3

1.0

2.0

2.0

mean 24-72h

1.4

0.3

2.0

1.6

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU

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