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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
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:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
m-phenylenediamine
EC Number:
203-584-7
EC Name:
m-phenylenediamine
Cas Number:
108-45-2
Molecular formula:
C6H8N2
IUPAC Name:
m-phenylenediamine
Details on test material:
-Purity: >99%

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: young adult
- Weight at study initiation: 2490 or 2536 grams
- Housing: The rabbits were housed singly in suspended, stainless steel, wire-mesh cages.
- Diet (e.g. ad libitum): The rabbits were offered approximately 125 grams of Purina Certified High Fiber Rabbit Chow daily during the study.
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Rabbits were quarantined, weighed, and observed for general health for approximately 2 weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 ± 10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye of each rabbit served as the control (untreated)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 0.01 g
- Concentration (if solution): N/A
Duration of treatment / exposure:
approximately 20 seconds
Observation period (in vivo):
7 days
Rabbits were observed during exposure and for approximately 30-60 seconds, 1 and 4 hours, and 1, 2, 3, and 7 days after administration of the test substance.
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes. Both eyes of the rabbit one rabbit were rinsed for approximately one minute with room temperature water. The eyes of the other rabbit were not washed.
- Time after start of exposure: Approximately 20 seconds

SCORING SYSTEM:
- Draize scale
- Eyes were also observed for any unusual responses to treatment such as pannus, blistering of the conjunctiva, ulceration, or other effects indicative of corrosive action.
- Control eyes were not scored. These untreated eyes were used for comparison and were considered "normal" relative to the treated eye.

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
- illumination and magnification

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: range
Time point:
other: 1 hour to 7 days
Score:
0 - 3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: See Tables 1 and 2 in IUCLID section 7.3.2 for complete individual rabbit scores
Irritation parameter:
iris score
Basis:
other: range
Time point:
other: 1 hour to 7 days
Score:
0 - 1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: See Tables 1 and 2 in IUCLID section 7.3.2 for complete individual rabbit scores
Irritation parameter:
conjunctivae score
Basis:
other: range
Time point:
other: 1 hour to 7 days
Score:
0 - 4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: See Tables 1 and 2 in IUCLID section 7.3.2 for complete individual rabbit scores

Any other information on results incl. tables

 

Table 1: Eye Irritation Reactions Observed in the Unwashed Rabbit Eye

Rabbit No. 30418

Cornea

Iritis

Conjunctiva

Opacity

Area

Redness

Chemosis

Discharge

1 Hour

3A

2

1

2

3B

3

4 Hours

3A

1

1

2

3B

3

1 Day

0

0

0

3H

2

3

2 Days

2A

2

0

3H

2B

1

3 Days

0

0

0

2H

2B

0

7 Days

0

0

0

0

0

0

A = Epithelial sloughing

B = Blistering of the conjunctiva

C = Hemorrhaging of the nictitating membrane

 

 

Table 2: Eye Irritation Reactions Observed in the Washed Rabbit Eye

Rabbit No. 30419

Cornea

Iritis

Conjunctiva

Opacity

Area

Redness

Chemosis

Discharge

1 Hour

3

3

1

2

3B

3

4 Hours

3

3

1

2

3B

3

1 Day

3A

3

1

3H

4B

3

2 Days

3A

3

1

3H

2B

2

3 Days

3A

3

1

2H

2B

2

7 Days

0

0

0

0

0

0

A = Epithelial sloughing

B = Blistering of the conjunctiva

H = Hemorrhaging of the nictitating membrane

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the conditions of this study, the test substance produced severe conjunctival redness, moderate corneal opacity, moderate iritis, copious discharge, hemorrhaging of the nictitating membrane, blistering of the conjunctiva, and epithelial sloughing of the cornea in both treated rabbit eyes. In addition, severe chemosis was observed in the treated unwashed rabbit eye. Both treated rabbit eyes were normal by 7 days following treatment.
Executive summary:

The test substance was evaluated for acute eye irritation potential in two young adult New Zealand white rabbits. Approximately 0.01 grams of the test substance was instilled into the lower conjunctival sac of the right eye of each animal. Approximately 20 seconds after instillation, the treated and control eyes of 1 rabbit were washed. The treated and control eyes of the remaining rabbit were not washed. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1 and 4 hours, and 1, 2, 3 and 7 days following administration. Under the conditions of this study, the test substance produced severe conjunctival redness, moderate corneal opacity, moderate iritis, copious discharge, hemorrhaging of the nictitating membrane, blistering of the conjunctiva, and epithelial sloughing of the cornea in both treated rabbit eyes. In addition, severe chemosis was observed in the treated unwashed rabbit eye. Both treated rabbit eyes were normal by 7 days following treatment. No adverse clinical signs of toxicity were observed during the study. One rabbit pawed its treated eye after instillation of the test substance.