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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: none provided
- Expiration date of the lot/batch: non provided
- Physical Appearance: light yellow powder
- Storage condition of test material: stored at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Male/ female -- ~16 weeks
- Weight at study initiation: Male/ female -- 3.4 - 3.6kg/ ~3.3kg
- Housing: suspended stainless stell cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 20
- Humidity (%): 48 - 55
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light):12/ 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0790g (or 0.1mL)
Duration of treatment / exposure:
15s
Duration of post- treatment incubation (in vitro):
72h
Number of animals or in vitro replicates:
3 (2 males and a female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline
- Time after start of exposure: 15s
- Observation: 1, 24, 48 and 72 h
- Mortality observation: done twice daily (morning and afternoon)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48hrs
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48hrs
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Ocular Observations Individual Data: Table 1
Obervations were based onthe Ocular Grading System presented which is based on Draize (1959)

Exposure to the test article produced iritis in 2/3 test eyes at the 1-hour scoring interval which resolved by 24 hours. Conjunctivitis (redness, swelling and discharge) was observed in 3/3 test eyes at the 1-hour scoring interval. The conjunctiva! irritation resolved completely in all test eyes by 48 hours. An additional ocular finding included test article present in the eye which was noted in 3/3 test eyes.

No corneal opacity, iritis or conjunctivitis was observed in the control eyes.

Any other information on results incl. tables

Table 1 A Primary Eye Irritation Study in Rabbits, INDIVIDUAL OCULAR IRRITATIONSCORES (NO RINSE GROUP)

Animal No./Sex

 

 

 

Test Eye

 

 

Control Eye

Body Weight

Scoring

Cornea

Iris_

Conjunctivae

S econdary

         

(kg)

Interval

0

A

OxAx5

I

lx5

R

S

D

(R+S+D)*2

Total

Fluorescein

Examination

Secondary

Ocular Findings

Fluorescein Examination

Secondary Ocular Findings

R3014/M

1 Hour

0

0

0

0

0

2

1

1

8

8

 

TAE

 

 

3.363

24 Hours

0

0

0

0

0

1

0

0

2

2

[-]

 

[-]

 

 

48 Hours

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

72 Hours

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

R3009/M

 

1 Hour

 

0

 

0

 

0

 

1

 

5

 

2

 

2

 

1

 

10

 

15

 

 

TAE

 

 

3.611

24 Hours

0

0

0

0

0

1

0

0

2

2

[-]

 

[-]

 

 

48 Hours

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

72 Hours

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

R3042/F

 

1 Hour

 

0

 

0

 

0

 

1

 

5

 

2

 

1

 

1

 

8

 

13

 

 

TAE

 

 

3.254

24 Hours

0

0

0

0

0

0

0

0

0

0

[-]

 

[-]

 

 

48 Hours

0

0

0

0

0

0

0

0

0

0

 

 

 

 

   72 Hours  0  0  0  0  0  0  0  0  0  0        

 

Mean Ocular Scores

1 Hour

12.00

24 Hours

1.33

48 Hours

0 00

72 Hours

0.00

Table 2 OCULAR EVALUATION CRITERIA

Maximum mean score (days 0-3)

Maximum mean score

Persistence of Individual Scores

Descriptive Rating and Class

0.00 - 0.49

24 hours= 0

 

Non-lrritating

1

24 hours> 0

 

Practically Non-lrritating

2

 

0.50 - 2.49

24 hours= 0

 

Non-lrritating

1

24 hours> 0

 

Practically Non-lrritating

2

 

2.50 - 14.99

48 hours= 0

 

Sliqht Irritant

3

48 hours> 0

 

Mild Irritant

4

 

15.00 - 24.99

72 hours= 0

 

Mild Irritant

4

72 hours> 0

 

Moderate Irritant

5

 

 

 

 

 

25.00 - 49.99

 

 

 

7 days 20

> half of day 7 scores

s 10

Moderate Irritant

5

"

·  > half of day 7 scores but no score >20

> 10,

Moderate Irritant

5

> half of day 7 scores and any score > 20

> 10,

Severe Irritant

6

7 day> 20

 

Severe Irritant

6

 

 

 

 

 

50.00 - 79.99

 

 

 

 

7 days 40

> half of day 7 scores

s 30

Severe Irritant

6

> half of day 7 scores but no score > 60

> 30,

Severe Irritant

6

> half of day 7 scores and any score > 60

> 30,

Very Severe Irritant

7

7 day> 40

 

Very Severe Irritant

7

 

 

 

 

80.00 - 99.99

 

 

 

7 days 80

> half of day 7 scores

s 60

Very Severe Irritant

7

> half of day 7 scores but no score > 100

> 60,

Very Severe Irritant

7

> half of day 7 scores and any score > 100

>60,

Extremely Severe Irritant 8

7 day> 80

 

Extremely Severe Irritant 8

 

100.00 - 110.00

7 days 80

 

Very Severe Irritant

7

7 day> 80

 

Extremely Severe Irritant 8

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the no rinse group, test item is considered to be slightly irritant to the ocular tissue of the rabbit.

Expose to the test item produced iritis in 2/3 test eyes at the 1-hour scoring interval which resolved by 24 hours.
Conjunctivitis (redness, swelling and discharge) was observed in 3/3 test eyes at the 1-hour scoring interval.
The conjunctival irritation resolved completely in all tests eyes by 48 hours.
An additional ocular finding included test item present in the eye which was noted in 3/3 test eyes.
No corneal opacity, iritis or conjunctivitis observed in the control eyes
Executive summary:

The potential irritant and/or corrosive effects of 2,4 Dinitroanisole were evaluated on the eyes of New Zealand White rabbits. Each of three rabbits received a 0.0790 g (0.1 ml weight equivalent) dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 72 hours following dosing.

 Exposure to the test article produced iritis in 2/3 test eyes at the 1-hour scoring interval which resolved by 24 hours. Conjunctivitis (redness, swelling and discharge) was observed in 3/3 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in all test eyes by 48 hours. An additional ocular finding included test article present in the eye which was noted in 3/3 test eyes.

Based on the no rinse group, 2,4-Dinitroanisole is considered to be a slight irritant to the ocular tissue of the rabbit, but not sufficient for classification under CLP regulation.