[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 Oct 1980 to 1 Nov 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

This acute eye irritation study was conducted prior to the adoption of OECD Guideline 405 (original adopted in 1981). However, the study was conducted in accordance with the test facility protocol and US FHSA guidelines available at the time. Study methods and results are well documented in the study report and summarised here.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins

Molecular formula:

Cannot be adequately determined for this UVCB substance

IUPAC Name:

Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins

Test material form:

liquid

Details on test material:

Test material is 65% of the registered substance diluted in 35% non-hazardous mineral oil. E-050 is described in the study reports as a thick, brown oily liquid.

Specific details on test material used for the study:

Test material is 65% of the registered substance diluted in 35% non-hazardous mineral oil. Described in the study reports as a thick, brown oily liquid.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: B and D Commercial Rabbitry, Malvern, Arkansas
- Age at study initiation: Young adults, at least 8 weeks old
- Weight at study initiation: 2424 -2843 g
- Housing: Individual housing in stainless steel cages, which were elevated above the droppings, in an environmentally controlled room. Rooms and cages maintained in accordance with the standards of the American Association for Accredication of Laboratory Animal Care (AAALAC). Sawdust, wood chips and other extraneous materials that might produce eye irritation were excluded from the animal facilities.
- Diet (e.g. ad libitum): Wayne Feeds Rabbit Ration available ad libitum
- Water (e.g. ad libitum): Tap water available ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 29 Oct 1980 To: 1 Nov 1980

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 of undiluted test material

Duration of treatment / exposure:

Single instillation into the conjunctival sac of the right eye. The lid was held together for one second to insure adequate distribution of the test material. Observations for eye irritation were made after 24, 48 and 72 hours. Left eye remained untreated and served as the control.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Six; 3 females and 3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
The treated eye was not irrigated.

SCORING SYSTEM: Method of Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope /
In addition to regular eye examination, the treated eyes of all animals were examined after application of sodium fluorescein 72 hours post treatment. The reading of reactions was facilitated by ophthalmoscopy.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Scattered or diffuse areas, details of iris clearly visible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

48 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Scattered or diffuse areas, details of iris clearly visible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Scattered or diffuse areas, details of iris clearly visible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

48 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Scattered or diffuse areas, details of iris clearly visible

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Easily discernible translucent areas, details of iris slightly obscured

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24 h

Score:

0

Reversibility:

other: Not applicable (no effects)

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

48 h

Score:

0

Reversibility:

other: Not applicable (no effects)

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

72 h

Score:

0

Reversibility:

other: Not applicable (no effects)

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24 h

Score:

0

Reversibility:

other: Not applicable (no effects)

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

48 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Scattered or diffuse areas, details of iris clearly visible

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24 h

Score:

0

Reversibility:

other: Not applicable (no effects)

Remarks on result:

no indication of irritation

Results 14

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

48 h

Score:

0

Reversibility:

other: Not applicable (no effects)

Remarks on result:

no indication of irritation

Results 15

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

72 h

Score:

0

Reversibility:

other: Not applicable (no effects)

Remarks on result:

no indication of irritation

Results 16

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24 h

Score:

0

Reversibility:

other: Not applicable (no effects)

Remarks on result:

no indication of irritation

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

48 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Scattered or diffuse areas, details of iris clearly visible

Results 18

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 19

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 20

Irritation parameter:

iris score

Basis:

animal #1

Time point:

48 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 21

Irritation parameter:

iris score

Basis:

animal #1

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 22

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 23

Irritation parameter:

iris score

Basis:

animal #2

Time point:

48 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 24

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 25

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 26

Irritation parameter:

iris score

Basis:

animal #3

Time point:

48 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 27

Irritation parameter:

iris score

Basis:

animal #3

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 28

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 29

Irritation parameter:

iris score

Basis:

animal #4

Time point:

48 h

Score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 30

Irritation parameter:

iris score

Basis:

animal #4

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 31

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 32

Irritation parameter:

iris score

Basis:

animal #5

Time point:

48 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 33

Irritation parameter:

iris score

Basis:

animal #5

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 34

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 35

Irritation parameter:

iris score

Basis:

animal #6

Time point:

48 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 36

Irritation parameter:

iris score

Basis:

animal #6

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Folds above normal, congestion, swelling, circumcorneal injection (any or all of these combinations of any thereof), iris still reacting to light (sluggish reaction is positive)

Results 37

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

More diffuse, deeper crimson red, individual vessels not easily discernible

Results 38

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

48 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

More diffuse, deeper crimson red, individual vessels not easily discernible

Results 39

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

More diffuse, deeper crimson red, individual vessels not easily discernible

Results 40

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

More diffuse, deeper crimson red, individual vessels not easily discernible

Results 41

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

48 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

More diffuse, deeper crimson red, individual vessels not easily discernible

Results 42

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

72 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

More diffuse, deeper crimson red, individual vessels not easily discernible

Results 43

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 44

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

48 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 45

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 46

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 47

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

48 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 48

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 49

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 50

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

48 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 51

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 52

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 53

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

48 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 54

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

72 h

Score:

1

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Vessels definitely injected above normal

Results 55

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Swelling with lids about half closed to completely closed

Results 56

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

48 h

Score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with lids about half closed

Results 57

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with lids about half closed

Results 58

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Swelling with lids about half closed to completely closed

Results 59

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

48 h

Score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with lids about half closed

Results 60

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with lids about half closed

Results 61

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 62

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

48 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 63

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

72 h

Score:

3

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with lids about half closed

Results 64

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 65

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

48 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 66

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

72 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 67

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 68

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

48 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 69

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

72 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 70

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 71

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

48 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 72

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

72 h

Score:

2

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other:

Remarks:

Obvious swelling with partial eversion of lids

Results 73

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

24 h

Score:

38

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of moderate irritation

Results 74

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

48 h

Score:

31

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of moderate irritation

Results 75

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

72 h

Score:

16

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 76

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

24 h

Score:

33

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of moderate irritation

Results 77

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

48 h

Score:

31

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of moderate irritation

Results 78

Irritation parameter:

overall irritation score

Basis:

animal #2

Time point:

72 h

Score:

41

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of moderate irritation

Results 79

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

24 h

Score:

19

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 80

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

48 h

Score:

19

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 81

Irritation parameter:

overall irritation score

Basis:

animal #3

Time point:

72 h

Score:

14

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Results 82

Irritation parameter:

overall irritation score

Basis:

animal #4

Time point:

24 h

Score:

17

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 83

Irritation parameter:

overall irritation score

Basis:

animal #4

Time point:

48 h

Score:

22

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 84

Irritation parameter:

overall irritation score

Basis:

animal #4

Time point:

72 h

Score:

12

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Results 85

Irritation parameter:

overall irritation score

Basis:

animal #5

Time point:

24 h

Score:

17

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 86

Irritation parameter:

overall irritation score

Basis:

animal #5

Time point:

48 h

Score:

17

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 87

Irritation parameter:

overall irritation score

Basis:

animal #5

Time point:

72 h

Score:

17

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 88

Irritation parameter:

overall irritation score

Basis:

animal #6

Time point:

24 h

Score:

19

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 89

Irritation parameter:

overall irritation score

Basis:

animal #6

Time point:

48 h

Score:

22

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 90

Irritation parameter:

overall irritation score

Basis:

animal #6

Time point:

72 h

Score:

17

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

Positive reactions were noted in the treated eyes of all six rabbits at the 24, 48 and 72 hour readings. In some animals, the cornea and iris effects were reversible within 72 hours, but this was not the case with the conjunctiva effects (erythema, chemosis, discharge) in any animal.

Other effects:

No abnormal appearance or behaviour was noted during the conduct of this study.

Any other information on results incl. tables

Rabbit	Time (hours)	Cornea		Iris	Conjunction			Total score
		Opacity	Area	Iritis	Erythema	Chemosis	Discharge
1	24	1	3	1	2	4	3	38
	48	1	2	1	2	3	3	31
	72	0	0	0	2	3	3	16
2	24	1	2	1	2	4	3	33
	48	1	2	1	2	3	3	31
	72	2	2	1	2	3	3	41
3	24	0	0	1	1	2	4	19
	48	0	0	1	1	2	4	19
	72	0	0	0	1	3	3	14
4	24	0	0	1	1	2	3	17
	48	1	1	1	1	2	3	22
	72	0	0	0	1	2	3	12
5	24	0	0	1	1	2	3	17
	48	0	0	1	1	2	3	17
	72	0	0	1	1	2	3	17
6	24	0	0	1	1	2	4	19
	48	1	1	1	1	2	3	22
	72	0	0	1	1	2	3	17

 

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Positive reactions were noted in the treated eyes of all six rabbits at the 24, 48 and 72 hour readings. Therefore, when instilled into the eyes of albino rabbits the test substance was considered to be a primary irritant as defined in the FHSA Regulations at 16 CFR 1500.3, as referenced in the study report. Some of the effects (cornea, iris) were reversible within 72 hours in some animals. However, the conjunctiva effects (erythema, chemosis, discharge) were not reversible within this time period. Since a 21-day observation period (as recommended by the current OECD Guideline) was not included in this study, it is unclear whether the remaining irritation effects would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for effects on the eye under GHS and CLP.

Executive summary:

A study was conducted in order to evaluate the eye irritation potential of the test substance in six New Zealand White rabbits (3/sex). The test substance was instilled into the conjunctival sac of the right eye of each animal. The lid was held together for one second to insure adequate distribution of the test material. Observations for eye irritation were made after 24, 48 and 72 hours. Positive reactions were noted in the treated eyes of all six rabbits at the 24, 48 and 72 hour readings. Some of the effects (cornea, iris) were reversible within 72 hours in some animals. However, the conjunctiva effects (erythema, chemosis, discharge) were not reversible within this time period. Since a 21-day observation period (as recommended by the current OECD Guideline) was not included in this study, it is unclear whether the remaining irritation effects would be reversible after a longer period of time. Therefore, as a worst case, the test substance is classified as Category 1 for irreversible effects on the eye under GHS and CLP.