Alcohols, C9-11-branched

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: 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

Test material information

Constituent 1

Reference substance name:

Alcohols, C9-11-branched

EC Number:

271-360-6

EC Name:

Alcohols, C9-11-branched

Cas Number:

68551-08-6

Molecular formula:

CnH2n+1OH (n = 10 to 12)

IUPAC Name:

Branched alcohols, C10-12, C11 rich

Test material form:

liquid

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

Results

Results 1

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72 H

Score:

0.05

Max. score:

2

Reversibility:

fully reversible

Remarks:

48 h

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 H

Score:

0

Max. score:

4

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: JEF656F

Time point:

24 h

Score:

2

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: JEF656F

Time point:

48 h

Score:

1

Max. score:

3

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal: JEF656F

Time point:

72 h

Score:

1

Max. score:

3

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal: JEF656F

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Results 8

Irritation parameter:

chemosis score

Basis:

animal: JEF656F

Time point:

24 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

chemosis score

Basis:

animal: JEF656F

Time point:

48 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

chemosis score

Basis:

animal: JEF656F

Time point:

72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

chemosis score

Basis:

animal: JEF656F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

iris score

Basis:

animal: JEF656F

Time point:

24 h

Score:

0

Max. score:

2

Results 13

Irritation parameter:

iris score

Basis:

animal: JEF656F

Time point:

48 h

Score:

0

Max. score:

2

Results 14

Irritation parameter:

iris score

Basis:

animal: JEF656F

Time point:

72 h

Score:

0

Max. score:

2

Results 15

Irritation parameter:

iris score

Basis:

animal: JEF656F

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 16

Irritation parameter:

cornea opacity score

Basis:

animal: JEF656F

Time point:

24 h

Score:

0

Max. score:

4

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal: JEF656F

Time point:

48 h

Score:

0

Max. score:

4

Results 18

Irritation parameter:

cornea opacity score

Basis:

animal: JEF656F

Time point:

72 h

Score:

0

Max. score:

4

Results 19

Irritation parameter:

cornea opacity score

Basis:

animal: JEF656F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 20

Irritation parameter:

conjunctivae score

Basis:

animal: JEF655M

Time point:

24 h

Score:

2

Max. score:

3

Results 21

Irritation parameter:

conjunctivae score

Basis:

animal: JEF655M

Time point:

48 h

Score:

2

Max. score:

3

Results 22

Irritation parameter:

conjunctivae score

Basis:

animal: JEF655M

Time point:

72 h

Score:

1

Max. score:

3

Results 23

Irritation parameter:

conjunctivae score

Basis:

animal: JEF655M

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Results 24

Irritation parameter:

chemosis score

Basis:

animal: JEF655M

Time point:

24 h

Score:

1

Max. score:

4

Results 25

Irritation parameter:

chemosis score

Basis:

animal: JEF655M

Time point:

48 h

Score:

0

Max. score:

4

Results 26

Irritation parameter:

chemosis score

Basis:

animal: JEF655M

Time point:

72 h

Score:

0

Max. score:

4

Results 27

Irritation parameter:

chemosis score

Basis:

animal: JEF655M

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Results 28

Irritation parameter:

iris score

Basis:

animal: JEF655M

Time point:

24 h

Score:

0

Max. score:

2

Results 29

Irritation parameter:

iris score

Basis:

animal: JEF655M

Time point:

48 h

Score:

0

Max. score:

2

Results 30

Irritation parameter:

iris score

Basis:

animal: JEF655M

Time point:

72 h

Score:

0

Max. score:

2

Results 31

Irritation parameter:

iris score

Basis:

animal: JEF655M

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 32

Irritation parameter:

cornea opacity score

Basis:

animal: JEF655M

Time point:

24 h

Score:

0

Max. score:

4

Results 33

Irritation parameter:

cornea opacity score

Basis:

animal: JEF655M

Time point:

48 h

Score:

0

Max. score:

4

Results 34

Irritation parameter:

cornea opacity score

Basis:

animal: JEF655M

Time point:

72 h

Score:

0

Max. score:

4

Results 35

Irritation parameter:

cornea opacity score

Basis:

animal: JEF655M

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 36

Irritation parameter:

conjunctivae score

Basis:

animal: JEF665M

Time point:

24 h

Score:

1

Max. score:

3

Results 37

Irritation parameter:

conjunctivae score

Basis:

animal: JEF665M

Time point:

48 h

Score:

1

Max. score:

3

Results 38

Irritation parameter:

conjunctivae score

Basis:

animal: JEF665M

Time point:

72 h

Score:

0

Max. score:

3

Results 39

Irritation parameter:

conjunctivae score

Basis:

animal: JEF665M

Time point:

24/48/72 h

Score:

0.22

Max. score:

3

Results 40

Irritation parameter:

chemosis score

Basis:

animal: JEF665M

Time point:

24 h

Score:

0

Max. score:

4

Results 41

Irritation parameter:

chemosis score

Basis:

animal: JEF665M

Time point:

48 h

Score:

0

Max. score:

4

Results 42

Irritation parameter:

chemosis score

Basis:

animal: JEF665M

Time point:

72 h

Score:

0

Max. score:

4

Results 43

Irritation parameter:

chemosis score

Basis:

animal: JEF665M

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 44

Irritation parameter:

iris score

Basis:

animal: JEF665M

Time point:

24 h

Score:

0

Max. score:

2

Results 45

Irritation parameter:

iris score

Basis:

animal: JEF665M

Time point:

48 h

Score:

0

Max. score:

2

Results 46

Irritation parameter:

iris score

Basis:

animal: JEF665M

Time point:

72 h

Score:

0

Max. score:

2

Results 47

Irritation parameter:

iris score

Basis:

animal: JEF665M

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 48

Irritation parameter:

cornea opacity score

Basis:

animal: JEF665M

Time point:

24 h

Score:

0

Max. score:

4

Results 49

Irritation parameter:

cornea opacity score

Basis:

animal: JEF665M

Time point:

48 h

Score:

0

Max. score:

4

Results 50

Irritation parameter:

cornea opacity score

Basis:

animal: JEF665M

Time point:

72 h

Score:

0

Max. score:

4

Results 51

Irritation parameter:

cornea opacity score

Basis:

animal: JEF665M

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 52

Irritation parameter:

conjunctivae score

Basis:

animal: JEF658F

Time point:

24 h

Score:

1

Max. score:

3

Results 53

Irritation parameter:

conjunctivae score

Basis:

animal: JEF658F

Time point:

48 h

Score:

1

Max. score:

3

Results 54

Irritation parameter:

conjunctivae score

Basis:

animal: JEF658F

Time point:

72 h

Score:

1

Max. score:

3

Results 55

Irritation parameter:

conjunctivae score

Basis:

animal: JEF658F

Time point:

24/48/72 h

Score:

1

Max. score:

3

Results 56

Irritation parameter:

chemosis score

Basis:

animal: JEF658F

Time point:

24 h

Score:

0

Max. score:

4

Results 57

Irritation parameter:

chemosis score

Basis:

animal: JEF658F

Time point:

48 h

Score:

0

Max. score:

4

Results 58

Irritation parameter:

chemosis score

Basis:

animal: JEF658F

Time point:

72 h

Score:

0

Max. score:

4

Results 59

Irritation parameter:

chemosis score

Basis:

animal: JEF658F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 60

Irritation parameter:

iris score

Basis:

animal: JEF658F

Time point:

24 h

Score:

0

Max. score:

2

Results 61

Irritation parameter:

iris score

Basis:

animal: JEF658F

Time point:

48 h

Score:

0

Max. score:

2

Results 62

Irritation parameter:

iris score

Basis:

animal: JEF658F

Time point:

72 h

Score:

0

Max. score:

2

Results 63

Irritation parameter:

iris score

Basis:

animal: JEF658F

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 64

Irritation parameter:

cornea opacity score

Basis:

animal: JEF658F

Time point:

24 h

Score:

0

Max. score:

4

Results 65

Irritation parameter:

cornea opacity score

Basis:

animal: JEF658F

Time point:

48 h

Score:

0

Max. score:

4

Results 66

Irritation parameter:

cornea opacity score

Basis:

animal: JEF658F

Time point:

72 h

Score:

0

Max. score:

4

Results 67

Irritation parameter:

cornea opacity score

Basis:

animal: JEF658F

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 68

Irritation parameter:

conjunctivae score

Basis:

animal: JEF657M

Time point:

24 h

Score:

2

Max. score:

3

Results 69

Irritation parameter:

conjunctivae score

Basis:

animal: JEF657M

Time point:

48 h

Score:

1

Max. score:

3

Results 70

Irritation parameter:

conjunctivae score

Basis:

animal: JEF657M

Time point:

72 h

Score:

1

Max. score:

3

Results 71

Irritation parameter:

conjunctivae score

Basis:

animal: JEF657M

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Results 72

Irritation parameter:

chemosis score

Basis:

animal: JEF657M

Time point:

24 h

Score:

1

Max. score:

4

Results 73

Irritation parameter:

chemosis score

Basis:

animal: JEF657M

Time point:

48 h

Score:

0

Max. score:

4

Results 74

Irritation parameter:

chemosis score

Basis:

animal: JEF657M

Time point:

72 h

Score:

0

Max. score:

4

Results 75

Irritation parameter:

chemosis score

Basis:

animal: JEF657M

Time point:

24/48/72 h

Score:

0.083

Max. score:

4

Results 76

Irritation parameter:

iris score

Basis:

animal: JEF657M

Time point:

24 h

Score:

0

Max. score:

2

Results 77

Irritation parameter:

iris score

Basis:

animal: JEF657M

Time point:

48 h

Score:

0

Max. score:

2

Results 78

Irritation parameter:

iris score

Basis:

animal: JEF657M

Time point:

72 h

Score:

0

Max. score:

2

Results 79

Irritation parameter:

iris score

Basis:

animal: JEF657M

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 80

Irritation parameter:

cornea opacity score

Basis:

animal: JEF657M

Time point:

24 h

Score:

0

Max. score:

4

Results 81

Irritation parameter:

cornea opacity score

Basis:

animal: JEF657M

Time point:

48 h

Score:

0

Max. score:

4

Results 82

Irritation parameter:

cornea opacity score

Basis:

animal: JEF657M

Time point:

72 h

Score:

0

Max. score:

4

Results 83

Irritation parameter:

cornea opacity score

Basis:

animal: JEF657M

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 84

Irritation parameter:

conjunctivae score

Basis:

animal: JEF662F

Time point:

24 h

Score:

2

Max. score:

3

Results 85

Irritation parameter:

conjunctivae score

Basis:

animal: JEF662F

Time point:

48 h

Score:

1

Max. score:

3

Results 86

Irritation parameter:

conjunctivae score

Basis:

animal: JEF662F

Time point:

72 h

Score:

2

Max. score:

3

Results 87

Irritation parameter:

conjunctivae score

Basis:

animal: JEF662F

Time point:

24/48/72 h

Score:

0.56

Max. score:

3

Results 88

Irritation parameter:

chemosis score

Basis:

animal: JEF662F

Time point:

24 h

Score:

1

Max. score:

4

Results 89

Irritation parameter:

chemosis score

Basis:

animal: JEF662F

Time point:

48 h

Score:

1

Max. score:

4

Results 90

Irritation parameter:

chemosis score

Basis:

animal: JEF662F

Time point:

72 h

Score:

0

Max. score:

4

Results 91

Irritation parameter:

chemosis score

Basis:

animal: JEF662F

Time point:

24/48/72 h

Score:

0.17

Max. score:

4

Results 92

Irritation parameter:

iris score

Basis:

animal: JEF662F

Time point:

24 h

Score:

1

Max. score:

2

Results 93

Irritation parameter:

iris score

Basis:

animal: JEF662F

Time point:

48 h

Score:

0

Max. score:

2

Results 94

Irritation parameter:

iris score

Basis:

animal: JEF662F

Time point:

72 h

Score:

0

Max. score:

2

Results 95

Irritation parameter:

iris score

Basis:

animal: JEF662F

Time point:

24/48/72 h

Score:

0.17

Max. score:

2

Results 96

Irritation parameter:

cornea opacity score

Basis:

animal: JEF662F

Time point:

24 h

Score:

0

Max. score:

4

Results 97

Irritation parameter:

cornea opacity score

Basis:

animal: JEF662F

Time point:

48 h

Score:

0

Max. score:

4

Results 98

Irritation parameter:

cornea opacity score

Basis:

animal: JEF662F

Time point:

72 h

Score:

0

Max. score:

4

Results 99

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.