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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: 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:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isoundecan-1-ol
EC Number:
257-376-6
EC Name:
Isoundecan-1-ol
Cas Number:
51750-47-1
Molecular formula:
C11H24O
IUPAC Name:
3,5 dimethyl nonanol-1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Sex: Male (3), Female (3)
- Age at study initiation: Approximately 14 weeks
- Weight at study initiation: 2.64-2.92 kg
- Housing: Individually
- Diet (e.g. ad libitum): Purina certified rabbit chow HF, ad libitum
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 14d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1987-08-17 To: 1978-08-31

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Contralateral, unexposed eye served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): Neat
Duration of treatment / exposure:
Test material was instilled into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were held together for approximately 1 second to prevent material loss. The contralateral eye served as the control.
Observation period (in vivo):
- 1, 4, 24, 48, and 72h post instillation and once per day on Days 4, 7, 10 and 14
Number of animals or in vitro replicates:
- Male (3), Female (3)
Details on study design:
SCORING SYSTEM:
- Ocular reactions scored according to the Draize scale

TOOL USED TO ASSESS SCORE:
- 2% sodium fluorescein dye was used to confirm the presence or absence of corneal ulceration in treated eyes.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 H
Score:
1.27
Max. score:
3
Reversibility:
not fully reversible within: 10 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 H
Score:
0.05
Max. score:
2
Reversibility:
fully reversible
Remarks:
48 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 H
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: JEF656F
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF656F
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF656F
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF656F
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: JEF656F
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF656F
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF656F
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF656F
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: JEF656F
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF656F
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF656F
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF656F
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: JEF656F
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF656F
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF656F
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF656F
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: JEF655M
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF655M
Time point:
48 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF655M
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF655M
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: JEF655M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF655M
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF655M
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF655M
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Irritation parameter:
iris score
Basis:
animal: JEF655M
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF655M
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF655M
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF655M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: JEF655M
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF655M
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF655M
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF655M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: JEF665M
Time point:
24 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF665M
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF665M
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF665M
Time point:
24/48/72 h
Score:
0.22
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: JEF665M
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF665M
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF665M
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF665M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: JEF665M
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF665M
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF665M
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF665M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: JEF665M
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF665M
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF665M
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF665M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: JEF658F
Time point:
24 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF658F
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF658F
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF658F
Time point:
24/48/72 h
Score:
1
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: JEF658F
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF658F
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF658F
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF658F
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: JEF658F
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF658F
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF658F
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF658F
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: JEF658F
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF658F
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF658F
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF658F
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: JEF657M
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF657M
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF657M
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF657M
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: JEF657M
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF657M
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF657M
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF657M
Time point:
24/48/72 h
Score:
0.083
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: JEF657M
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF657M
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF657M
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF657M
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: JEF657M
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF657M
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF657M
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF657M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal: JEF662F
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF662F
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF662F
Time point:
72 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: JEF662F
Time point:
24/48/72 h
Score:
0.56
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: JEF662F
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF662F
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF662F
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: JEF662F
Time point:
24/48/72 h
Score:
0.17
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: JEF662F
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF662F
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF662F
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: JEF662F
Time point:
24/48/72 h
Score:
0.17
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
animal: JEF662F
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF662F
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF662F
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: JEF662F
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
A conjunctival response was observed in all animals and consisted of redness, chemosis, and discharge. Redness was noted in all animals up to 24h post instillation. The incidence of redness steadily decreased through Day 14. Chemosis was noted in 4 animals at the 1 hour observation, and in 5 animals at the 4h observation. After 4 hours, the incidence of chemosis decreased. White discharge was noted in 4 animals at 1 and 4h post instillation. Iridial responses were not noted after the 24 hour observation. Corneal ulceration was noted in 1 animal at the 24 h observation. Ocular irritation was most prominent at the 1 and 4 h observations where the total Draize score ranged from 2 to 19 (out of 110).
Other effects:
- All animals survived the exposure

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Does not require classification. Criteria used for interpretation of results: EU
Conclusions:
The eye irritation potential for isoundecanol is minimal.
Executive summary:

Isoundecanol was administered via instillation into the eye to 6 rabbits at a dose of 0.5 ml neat solution.  Ocular examinations occurred at 1h, 4h, 24h, 48h, 72h, Day 4, Day 7, Day 10, and Day 14 post instillation. Ocular damage was assessed and scored according to the Draize eye test. All animals survived the exposure. Ocular irritation was most prominent at the 1 and 4 h observation point where the total Draize score ranged from 2 to 19. Irritation subsided as the study progressed and by Day 14, 2 animals were clear of ocular irritation. The remaining 4 animals exhibited conjunctival redness with a corresponding Draize score of 1.  The eye irritation potential for isotridecanol is minimal. Mean eye irritation scores between 24 and 72 hours were: cornea score 0, iris score 0.05, and conjunctival redness 1.27.

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