Registration Dossier

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: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Exxal 13
- Physical state: clear colorless liquid
- Stability under test conditions: stable at room temperature
- 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: Kleintierfarm Madoerin AG
- Age at study initiation: 14 – 15 weeks
- Weight at study initiation: 2.1-2.9 kg
- Housing: individually
- Diet (e.g. ad libitum): Kliba 341 rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): assumed 100%
Duration of treatment / exposure:
In 3 out of 6 rabbits, approximately 30 seconds after treatment, the treated eye was flushed with lukewarm physiological saline for about one minute
Observation period (in vivo):
1, 24, 48, and 72 hours and 7 and 14 days post exposure
Number of animals or in vitro replicates:
6 total (3 males rinsed 30 seconds after exposure, 3 females unrinsed)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 30 seconds after exposure in 3 animals

SCORING SYSTEM:
Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 through 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 through 72 hours
Score:
1.22
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Unrinsed eyes
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0
Max. score:
4
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0
Max. score:
2
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0
Max. score:
3
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0
Max. score:
4
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #7, Male
Time point:
other: 1h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #8, Male
Time point:
other: 1h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #9, Male
Time point:
other: 1h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #10, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #11, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #12, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #7, Male
Time point:
24 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #8, Male
Time point:
24 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #9, Male
Time point:
24 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #10, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #11, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #12, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #7, Male
Time point:
48 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #8, Male
Time point:
48 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #9, Male
Time point:
48 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #10, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #11, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #12, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #7, Male
Time point:
72 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #8, Male
Time point:
72 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #9, Male
Time point:
72 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #10, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #11, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #12, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #7, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #8, Male
Time point:
7 d
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #9, Male
Time point:
7 d
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #10, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #11, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #12, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #7, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #8, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #9, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
cornea opacity score
Basis:
other: Animal #10, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #11, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
cornea opacity score
Basis:
other: Animal #12, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #7, Male
Time point:
other: 1h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #8, Male
Time point:
other: 1h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #9, Male
Time point:
other: 1h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #10, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #11, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #12, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #7, Male
Time point:
24 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #8, Male
Time point:
24 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #9, Male
Time point:
24 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #10, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #11, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #12, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #7, male
Time point:
48 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #8, Male
Time point:
48 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #9, Male
Time point:
48 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #10, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #11, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #12, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #7, Male
Time point:
72 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #8, Male
Time point:
72 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #9, Male
Time point:
72 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #10, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #10, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #11, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #12, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #7, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #8, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #9, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #10, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #11, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #12, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #7, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #8, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #9, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
iris score
Basis:
other: Animal #10, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #11, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
iris score
Basis:
other: Animal #12, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #7, Male
Time point:
other: 1h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #8, Male
Time point:
other: 1h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #9, Male
Time point:
other: 1h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #10, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #11, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #12, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #7, Male
Time point:
24 h
Score:
2
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #8, Male
Time point:
24 h
Score:
2
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #9, Male
Time point:
24 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #10, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #11, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #12, female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #7, Male
Time point:
48 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #8, Male
Time point:
48 h
Score:
2
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #9, male
Time point:
48 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #10, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #11, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #12, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #7, Male
Time point:
72 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #8, Male
Time point:
72 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #9, Male
Time point:
72 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #10, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #11, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #12, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #7, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not RInsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #8, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not RInsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #9, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #10, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #11, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #12, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #7, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #8, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #9, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
conjunctivae score
Basis:
other: Animal #10, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #11, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
conjunctivae score
Basis:
other: Animal #12, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #7, Male
Time point:
other: 1h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #8, Male
Time point:
other: 1h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #9, Male
Time point:
other: 1h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #10, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #11, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #12, Female
Time point:
other: 1h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #7, Male
Time point:
24 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #8, Male
Time point:
24 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #9, Male
Time point:
24 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #10, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #11, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #12, Female
Time point:
24 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #7, Male
Time point:
48 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #8, Male
Time point:
48 h
Score:
1
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #9, Male
Time point:
48 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #10, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #11, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #12, Female
Time point:
48 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #7, Male
Time point:
72 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #8, Male
Time point:
72 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #9, Male
Time point:
72 h
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #10, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #11, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #12, Female
Time point:
72 h
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #7, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #8, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #9, Male
Time point:
7 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #10, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #11, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #12, Female
Time point:
7 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #7, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #8, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #9, Male
Time point:
14 d
Score:
0
Remarks on result:
other: Not Rinsed
Irritation parameter:
chemosis score
Basis:
other: Animal #10, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #11, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritation parameter:
chemosis score
Basis:
other: Animal #12, Female
Time point:
14 d
Score:
0
Remarks on result:
other: Rinsed eyes
Irritant / corrosive response data:
No staining of the corneas and conjunctivae was observed in the rabbits during the entire test period which could be related to the test article effects. No corrosion effect was observed at each of the measuring intervals. No acute toxicological signs were observed in the animals during the test.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified Criteria used for interpretation of results: EU
Conclusions:
The eye irritation potential for isotridecanol is minimal.
Executive summary:

In this study, isotridecanol was evaluated for its eye irritation potential in rabbits.  0.1 ml was instilled into the left eye of 6 rabbits.  Thirty seconds after instillation, 3 of the 6 rabbits had their eyes rinsed clear of the test material.  All rabbits were examined at 1, 24, 48 and 72 hours and 7 and 14 days post exposure.  No staining of the corneas and conjunctivae was observed in the rabbits during the entire test period which could be related to the test article effects.  No corrosion effect was observed at each of the measuring intervals.  No acute toxicological signs were observed in the animals during the test.  The signs of slight irritation that were noted in the 3 rabbits of the un-rinsed group were typically resolved by the 7 day observation period.  The eye irritation potential for isotridecanol is minimal. Mean eye irritation scores between 24 and 72 hours were: cornea score 1, iris score 0.33, conjunctival redness 1.22, and chemosis 0.33.