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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-biphenylate
EC Number:
205-055-6
EC Name:
Sodium 2-biphenylate
Cas Number:
132-27-4
Molecular formula:
C12H9NaO
IUPAC Name:
sodium 2-phenylphenolate
Test material form:
solid: particulate/powder
Details on test material:
Batch No.: 80/07319

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd. (breeder)
- Weight at study initiation: 3.0, 3.1 and 3.6 kg, respectively
- Housing: The rabbits were individually housed in single cages (wire cages type III-high). Below the cages excrement trays with low-dust wood granulate type S 8/15 (Ssniff, Soest, Germany) were located.
- Diet: Standard diet "Ssniff K 4" (supplied by Versuchstierdiäten GmbH, Soest, Germany), approximately 100 - 120 g per animal and day
- Water: Tap water, ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): Approximately 50
- Air changes (per hr): Approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 Mar 1988 To: 15 Mar 1988

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with pysiological sodium chloride solution.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 1% fluorescein solution and ultraviolet light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 3 rabbits
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 3 rabbits
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 3 rabbits
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 3 rabbits
Time point:
24/48/72 h
Score:
1.78
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
within 7 days
Irritant / corrosive response data:
Animal #1 and #2 showed a cornea opacity score of 2 at the 1-, 24-, 48- and 72-h reading time point, which increased at the 7-day reading time point (score of 3). Animal #3 showed a cornea opacity score of 1 at all reading time points. The iris score was 1 and the conjunctivae score was 2 for all 3 rabbits at all reading time points. A slight swelling (chemosis score of 1) was determined in rabbit #1 at the 1-h and 7-day reading time point, which enhanced to a distinct swelling (score of 2) at the 24-, 48- and 72-h reading time point. A slight swelling was also observed at the 1-h reading time point in rabbit #2, which resulted in a distinct swelling (score of 2) at the 24- and 48-h reading time point in a score of 3 at the 72-h reading time point. This effect was not reversible within 7 days (score 2). Rabbit #3 showed a chemosis score of 1 at all reading time points.
The mucous membrane of the third eyelid of the animals was necrotized from the first evaluation. At the 7-day reading time point, 1/3 rabbits had a corneal pannus and hair loss at the upper and lower margin of the eyelid, respectively.

Any other information on results incl. tables

Table 1: Summary of Results

Rabbit # Time [h] conjunctivae iris cornea
redness swelling
1 1 2 1 1 2
24 2 2 1 2
48 2 2 1 2
72 2 2 1 2
average 2,0 2,0 1,0 2,0
2 1 2 1 1 2
24 2 2 1 2
48 2 2 1 2
72 2 3 1 2
average 2,0 2,3 1,0 2,0
3 1 2 1 1 1
24 2 1 1 1
48 2 1 1 1
72 2 1 1 1
average 2,0 1,0 1,0 1,0
   
Time [h] conjunctivae iris cornea
  redness swelling    
average
score		 1 2,00 1,00 1,00 1,67
24 2,00 1,67 1,00 1,67
48 2,00 1,67 1,00 1,67
72 2,00 2,00 1,00 1,67
24+48+72 2,00 1,78 1,00 1,67

Applicant's summary and conclusion

Interpretation of results:
other: Eye Dam. 1, H318 according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: Eye Dam. 1, H318