Amines, C12-14-alkyl, isooctyl phosphates

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C12-14-tert-alkyl, isooctyl mono phosphates

IUPAC Name:

Amines, C12-14-tert-alkyl, isooctyl mono phosphates

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: Young adult male and female albino New Zealand rabbits obtained from Clerco Research Farm, Cincinnati, OH, USA
- Housing: The animals were housed individually in stainless steel cages with wire mesh floors.
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow 5322 was fed throughout the study.
- Water (e.g. ad libitum): Free access to filtered tap water was provided through an automatic watering system.
- Acclimation period: 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 67 ± 5 F
- Humidity (%): 30 - 70%
- Ventilation: The animal room was well ventilated and air conditioned
- Photoperiod (hrs dark / hrs light): lighting was controlled by automatic timers to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other:

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 0.1ml

Observation period (in vivo):

1hr, 24, 48 and 72 hours and 7 days after instillation of the test item

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were not washed after treatment


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: A pocket flashlight without magnification was used at all evaluation intervals. A 2% sodium Fluorescein solution in deionised water was used at all evaluations except for those done at 1 hour after instillation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

48 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

7 d

Score:

ca. 0

Max. score:

4

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

48 hours

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Time point:

48 h

Score:

ca. 0

Max. score:

2

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

72 h

Score:

ca. 0

Max. score:

2

Results 8

Irritation parameter:

iris score

Basis:

animal #1

Time point:

7 d

Score:

ca. 0

Max. score:

2

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

ca. 3

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Remarks on result:

other: Blistering of conjunctiva observed

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

48 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

7 d

Score:

ca. 0

Max. score:

3

Results 13

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 14

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

48 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 15

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 16

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

7 d

Score:

ca. 0

Max. score:

4

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

48 hours

Results 18

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

48 h

Score:

ca. 0

Max. score:

4

Results 19

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Score:

ca. 0

Max. score:

4

Results 20

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

7 d

Score:

ca. 0

Max. score:

4

Results 21

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

48 hours

Results 22

Irritation parameter:

iris score

Basis:

animal #2

Time point:

48 h

Score:

ca. 0

Max. score:

2

Results 23

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Score:

ca. 0

Max. score:

2

Results 24

Irritation parameter:

iris score

Basis:

animal #2

Time point:

7 d

Score:

ca. 0

Max. score:

2

Results 25

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

ca. 3

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Remarks on result:

other:

Remarks:

Blistering observed

Results 26

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

48 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 27

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

72 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 28

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

7 d

Score:

ca. 0

Max. score:

3

Results 29

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

72 hours

Results 30

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

48 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

72 hours

Results 31

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

ca. 0

Max. score:

4

Results 32

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

7 d

Score:

ca. 0

Max. score:

4

Results 33

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 34

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

48 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 35

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 36

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

7 d

Score:

ca. 0

Max. score:

4

Results 37

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

72 hours

Results 38

Irritation parameter:

iris score

Basis:

animal #3

Time point:

48 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

72 hours

Results 39

Irritation parameter:

iris score

Basis:

animal #3

Time point:

72 h

Score:

ca. 0

Max. score:

2

Results 40

Irritation parameter:

iris score

Basis:

animal #3

Time point:

7 d

Score:

ca. 0

Max. score:

2

Results 41

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Score:

ca. 3

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 42

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

48 h

Score:

ca. 3

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 43

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

ca. 3

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 44

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

7 d

Score:

ca. 0

Max. score:

3

Results 45

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 46

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

48 h

Score:

ca. 3

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 47

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

72 h

Score:

ca. 3

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 48

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

7 d

Score:

ca. 0

Max. score:

4

Results 49

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 50

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

48 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 51

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

72 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 52

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

7 d

Score:

ca. 0

Max. score:

4

Remarks on result:

other: Pannus observed

Results 53

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 days

Results 54

Irritation parameter:

iris score

Basis:

animal #4

Time point:

48 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 days

Results 55

Irritation parameter:

iris score

Basis:

animal #4

Time point:

72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 days

Results 56

Irritation parameter:

iris score

Basis:

animal #4

Time point:

7 d

Score:

ca. 0

Max. score:

2

Results 57

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24 h

Score:

ca. 3

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Remarks on result:

other: blistering observed

Results 58

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

48 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 59

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

72 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 60

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

7 d

Score:

ca. 0

Max. score:

3

Results 61

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24 h

Score:

ca. 3

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 62

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

48 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 63

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

72 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 64

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

7 d

Score:

ca. 0

Max. score:

4

Results 65

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24 h

Score:

ca. 1

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 66

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

48 h

Score:

ca. 2

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 67

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

72 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 68

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

7 d

Score:

ca. 2

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

7 days

Remarks on result:

other: Pannus observed

Results 69

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 days

Results 70

Irritation parameter:

iris score

Basis:

animal #5

Time point:

48 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 days

Results 71

Irritation parameter:

iris score

Basis:

animal #5

Time point:

72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 days

Results 72

Irritation parameter:

iris score

Basis:

animal #5

Time point:

7 d

Score:

ca. 0

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 days

Results 73

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24 h

Score:

ca. 3

Max. score:

3

Reversibility:

not fully reversible within:

Remarks:

7 day observation period

Remarks on result:

other: bistering observed

Results 74

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

48 h

Score:

ca. 3

Max. score:

3

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 75

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

72 h

Score:

ca. 3

Max. score:

3

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 76

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

7 d

Score:

ca. 1

Max. score:

3

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 77

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24 h

Score:

ca. 4

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 78

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

48 h

Score:

ca. 4

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 79

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

72 h

Score:

ca. 4

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 80

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

7 d

Score:

ca. 2

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

7 days

Results 81

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 82

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

48 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 83

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 84

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

7 d

Score:

ca. 0

Max. score:

4

Results 85

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

48 hours

Results 86

Irritation parameter:

iris score

Basis:

animal #6

Time point:

48 h

Score:

ca. 0

Max. score:

2

Results 87

Irritation parameter:

iris score

Basis:

animal #6

Time point:

72 h

Score:

ca. 0

Max. score:

2

Results 88

Irritation parameter:

iris score

Basis:

animal #6

Time point:

7 d

Score:

ca. 0

Max. score:

2

Results 89

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24 h

Score:

ca. 3

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 90

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

48 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

7 days

Results 91

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

72 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible

Remarks:

7 days

Results 92

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

7 d

Score:

ca. 0

Max. score:

3

Results 93

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 94

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

48 h

Score:

ca. 2

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 95

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

72 h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within:

Remarks:

7 days

Results 96

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

7 d

Score:

ca. 0

Max. score:

4

Irritant / corrosive response data:

See attached background information.

Other effects:

No mortalities and no abnormal clinical signs were observed during the study.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the conditions of the study the test article was considered to be moderatly irritating.

Executive summary:

Introduction

The study was performed to evaluate the primary eye irritancy potential of the test item. 

Method

After instillation of 0.1ml the test item to the right eye of 6 rabbits the eyes were examined for ocular irritation and lesions at 1 hour, 24 hour, 48 hour , 72 hours and a 7 day interval.

Results

Incidences of redness, chemosis, discharge and iritis were observed together with blistering of the conjuntivae, white discharge, opacities, positive fluorescein staining and pannus. The test article was considered to be moderately irritating.

No mortalities occurred during the study and all animals were free of overt signs of toxicity.