Triethyl borate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit a meaningful evaluation of study results. Though the study was not conducted in accordance to GLP, the report carries a Quality assurance inspection note

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water. The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trimethyl borate

EC Number:

204-468-9

EC Name:

Trimethyl borate

Cas Number:

121-43-7

Molecular formula:

C3H9BO3

IUPAC Name:

trimethyl borate

Test material form:

liquid

Specific details on test material used for the study:

Name of test material (as cited in study report): TS2-16A Trimethyl Borate- Physical state: Liquid- Analytical purity: 99.2%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS- Source: Langshaw Farms of Augusta, Michigan- Weight at study initiation: 2220 to 3115 grams- Housing: Individually housed in hanging wire-mesh cage- Identification: Ear tag- Diet: Purina Certified Rabbit Chow, ad libitum- Water: Ad libitum- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°F): 64-82- Humidity (%): 35-68%- Photoperiod (12 hrs dark / 12 hrs light)IN-LIFE DATES: From: November 8, 1979 To: December 13, 1979

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 ml, undiluted

Duration of treatment / exposure:

Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds.

Observation period (in vivo):

Observation period: 35 daysThe unwashed group was terminated from the study on day 19

Number of animals or in vitro replicates:

9

Details on study design:

Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Approximately 24 hours prior to test material administration the eyes of potential study animals were observed for gross lesions and subjected to ultraviolet light examination following instillation of 1 drop of 2.0 percent Sodium fluorescein directly onto the corneal surface which was rinsed after a few seconds with distilled water. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. These 9 rabbits were administered 0.1 ml of the test material as received, undiluted. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for 1 second. Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds. The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

24 h

Score:

7.5

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

48 h

Score:

11.3

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

72 h

Score:

11.3

Reversibility:

fully reversible

Results 4

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

other: 96h

Score:

5

Reversibility:

fully reversible

Results 5

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 6

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

48 h

Score:

5

Reversibility:

fully reversible

Results 7

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

72 h

Score:

2.5

Reversibility:

fully reversible

Results 8

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

other: 96h

Score:

0

Reversibility:

fully reversible

Results 9

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

24 h

Score:

14

Reversibility:

fully reversible

Results 10

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

48 h

Score:

13

Reversibility:

fully reversible

Results 11

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No. 5037, Male

Time point:

72 h

Score:

9

Reversibility:

fully reversible

Results 12

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #1

Remarks:

Animal No.5037, Male

Time point:

other: 96h

Score:

5

Reversibility:

fully reversible

Results 13

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

24 h

Score:

7.5

Reversibility:

fully reversible

Results 14

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

48 h

Score:

20

Reversibility:

fully reversible

Results 15

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

72 h

Score:

20

Reversibility:

fully reversible

Results 16

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

other: 96h

Score:

5

Reversibility:

fully reversible

Results 17

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 18

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

48 h

Score:

5

Reversibility:

fully reversible

Results 19

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

72 h

Score:

5

Reversibility:

fully reversible

Results 20

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

other: 96h

Score:

0

Reversibility:

fully reversible

Results 21

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal 5047, Male

Time point:

24 h

Score:

15

Reversibility:

fully reversible

Results 22

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

48 h

Score:

18

Reversibility:

fully reversible

Results 23

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal 5047, Male

Time point:

72 h

Score:

12

Reversibility:

fully reversible

Results 24

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #2

Remarks:

Animal No. 5047, Male

Time point:

other: 96h

Score:

6

Reversibility:

fully reversible

Results 25

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 26

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

48 h

Score:

11.3

Reversibility:

fully reversible

Results 27

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

72 h

Score:

20

Reversibility:

fully reversible

Results 28

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

other: 96h

Score:

7.5

Reversibility:

fully reversible

Results 29

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 30

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

48 h

Score:

5

Reversibility:

fully reversible

Results 31

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

72 h

Score:

5

Reversibility:

fully reversible

Results 32

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

other: 96h

Score:

5

Reversibility:

fully reversible

Results 33

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

24 h

Score:

15

Reversibility:

fully reversible

Results 34

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

48 h

Score:

17

Reversibility:

fully reversible

Results 35

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

72 h

Score:

15

Reversibility:

fully reversible

Results 36

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #3

Remarks:

Animal No. 5055, Male

Time point:

other: 96h

Score:

8

Reversibility:

fully reversible

Results 37

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

24 h

Score:

15

Reversibility:

fully reversible

Results 38

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

48 h

Score:

15

Reversibility:

fully reversible

Results 39

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

72 h

Score:

10

Reversibility:

fully reversible

Results 40

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

other: 96h

Score:

15

Reversibility:

fully reversible

Results 41

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 42

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

48 h

Score:

5

Reversibility:

fully reversible

Results 43

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

72 h

Score:

2.5

Reversibility:

fully reversible

Results 44

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

other: 96h

Score:

0

Reversibility:

fully reversible

Results 45

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal 5044, Female

Time point:

24 h

Score:

16

Reversibility:

fully reversible

Results 46

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

48 h

Score:

10

Reversibility:

fully reversible

Results 47

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044,, Female

Time point:

72 h

Score:

8

Reversibility:

fully reversible

Results 48

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #4

Remarks:

Animal No. 5044, Female

Time point:

other: 96h

Score:

6

Reversibility:

fully reversible

Results 49

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

24 h

Score:

15

Reversibility:

fully reversible

Results 50

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

48 h

Score:

20

Reversibility:

fully reversible

Results 51

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

72 h

Score:

15

Reversibility:

fully reversible

Results 52

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

other: 96h

Score:

15

Reversibility:

fully reversible

Results 53

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 54

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

48 h

Score:

5

Reversibility:

fully reversible

Results 55

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

72 h

Score:

2.5

Reversibility:

fully reversible

Results 56

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

other: 96h

Score:

0

Reversibility:

fully reversible

Results 57

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

24 h

Score:

17

Reversibility:

fully reversible

Results 58

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

48 h

Score:

19

Reversibility:

fully reversible

Results 59

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

72 h

Score:

11

Reversibility:

fully reversible

Results 60

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #5

Remarks:

Animal No. 5046, Female

Time point:

other: 96h

Score:

8

Reversibility:

fully reversible

Results 61

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

24 h

Score:

11.3

Reversibility:

fully reversible

Results 62

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

48 h

Score:

11.3

Reversibility:

fully reversible

Results 63

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

72 h

Score:

11.3

Reversibility:

fully reversible

Results 64

Irritation parameter:

cornea opacity score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

other: 96h

Score:

7.5

Reversibility:

fully reversible

Results 65

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 66

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

48 h

Score:

5

Reversibility:

fully reversible

Results 67

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Results 68

Irritation parameter:

iris score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

other: 96h

Score:

0

Reversibility:

fully reversible

Results 69

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

24 h

Score:

17

Reversibility:

fully reversible

Results 70

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

48 h

Score:

11

Reversibility:

fully reversible

Results 71

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

72 h

Score:

9

Reversibility:

fully reversible

Results 72

Irritation parameter:

conjunctivae score

Remarks:

Unwashed

Basis:

animal #6

Remarks:

Animal No. 5052, Female

Time point:

other: 96h

Score:

9

Reversibility:

fully reversible

Results 73

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

24 h

Score:

20

Reversibility:

fully reversible

Results 74

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

48 h

Score:

25

Reversibility:

fully reversible

Results 75

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

72 h

Score:

25

Reversibility:

fully reversible

Results 76

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

other: 96h

Score:

20

Reversibility:

fully reversible

Results 77

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 78

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

48 h

Score:

5

Reversibility:

fully reversible

Results 79

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

72 h

Score:

5

Reversibility:

fully reversible

Results 80

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

other: 96h

Score:

5

Reversibility:

fully reversible

Results 81

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

24 h

Score:

18

Reversibility:

fully reversible

Results 82

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

48 h

Score:

18

Reversibility:

fully reversible

Results 83

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

72 h

Score:

13

Reversibility:

fully reversible

Results 84

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #7

Remarks:

Animal No. 5051, Male

Time point:

other: 96h

Score:

8

Reversibility:

fully reversible

Results 85

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

24 h

Score:

20

Reversibility:

not fully reversible within: 34 days

Results 86

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal no. 5053, Male

Time point:

48 h

Score:

31.3

Reversibility:

not fully reversible within: 34 days

Results 87

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

72 h

Score:

31.3

Reversibility:

not fully reversible within: 34 days

Results 88

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

other: 96h

Score:

31.3

Reversibility:

not fully reversible within: 34 days

Results 89

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 90

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

48 h

Score:

5

Reversibility:

fully reversible

Results 91

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

72 h

Score:

5

Reversibility:

fully reversible

Results 92

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

other: 96h

Score:

5

Reversibility:

fully reversible

Results 93

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

24 h

Score:

18

Reversibility:

not fully reversible within: 34 days

Results 94

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

48 h

Score:

19

Reversibility:

not fully reversible within: 34 days

Results 95

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

72 h

Score:

18

Reversibility:

not fully reversible within: 34 days

Results 96

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #8

Remarks:

Animal No. 5053, Male

Time point:

other: 96h

Score:

15

Reversibility:

not fully reversible within: 34 days

Results 97

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

24 h

Score:

7.5

Reversibility:

fully reversible

Results 98

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

48 h

Score:

7.5

Reversibility:

fully reversible

Results 99

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

72 h

Score:

5

Reversibility:

fully reversible

Results 100

Irritation parameter:

cornea opacity score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

other: 96h

Score:

5

Reversibility:

fully reversible

Results 101

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

24 h

Score:

5

Reversibility:

fully reversible

Results 102

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

48 h

Score:

5

Reversibility:

fully reversible

Results 103

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

72 h

Score:

2.5

Reversibility:

fully reversible

Results 104

Irritation parameter:

iris score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

other: 96h

Score:

0

Reversibility:

fully reversible

Results 105

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

24 h

Score:

17

Reversibility:

fully reversible

Results 106

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

48 h

Score:

13

Reversibility:

fully reversible

Results 107

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

72 h

Score:

7

Reversibility:

fully reversible

Results 108

Irritation parameter:

conjunctivae score

Remarks:

Washed

Basis:

animal: #9

Remarks:

Animal No. 5054, Female

Time point:

other: 96h

Score:

5

Reversibility:

fully reversible

Results 109

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

No data

Irritant / corrosive response data:

0.1 ml/right eye, unwashed - Primary eye irritant0.1 ml/right eye, washed - Primary eye irritantCLASSIFICATION0.1 ml/right eye, unwashed -Moderately irritating 0.1 ml/right eye, washed - Moderately irritating

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Remarks:

Migrated informationCriteria used for interpretation of results: expert judgment

Conclusions:

Test material was evaluated as primary eye irritant and classified as moderatley irritating.

Executive summary:

Acute ocular irritation potential study was conducted in New Zealand White rabbits, six of either sex. Approximately 24 hours prior to test material administration the eyes of potential study animals were observed for gross lesions and subjected to ultraviolet light examination following instillation of 1 drop of 2.0 percent Sodium fluorescein directly onto the corneal surface which was rinsed after a few seconds with distilled water. Out of the total 12 animals, 9 rabbits (5 male and 4 female) were randomly selected for test material administration. These 9 rabbits were administered 0.1 ml of the test material as received, undiluted. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for 1 second.

Left eye served as a control for each rabbit and was treated in a manner identical to the right eye, except the admnistration of test material. Three of the 9 rabbits received a washout 30 seconds following instillation with 100 ml of lukewarm tap water for a duration of 55 to 60 seconds.

The animals were examined for eye observations, mortality, pharmacotoxic signs and body weights. The observation period was of 35 days. The unwashed group was terminated from the study on day 19.

Based on the results, test material was evaluated as primary eye irritant and classified as moderately irritating.