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EC number: 248-421-0 | CAS number: 27344-41-8
Eye irritation
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:
- 1 991
- 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
- 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'-(biphenyl-4,4'-diyldiethene-2,1-diyl)dibenzenesulfonate
- 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
Constituent 1
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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