Registration Dossier

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:
From Feb. 13, 1979 to Feb. 20, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, comparable to scientific standards/principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study was performed to determine the eye irritation potential of test substance in the rabbit eye. The test substance was applied undiluted to one eye. The eyes were evaluated for signs of toxicity/irritation.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate
- TSIN: A-50
- Substance type: Pure active substance
- Physical state: Solid
No other information on the test substance was provided in the study report.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
EXPERIMENT INITIATION DATE: Feb. 13, 1979
EXPERIMENT COMPLETION DATE: Feb. 20, 1979
No details on test animals and environmental conditions were provided in the study report.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 100 mg
Duration of treatment / exposure:
Once (unwashed)
Observation period (in vivo):
Day 1, 2, 3 and 4 following treatment
Number of animals or in vitro replicates:
6 animals (2 males and 4 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE: Eyes were not washed after treatment.

SCORING SYSTEM: The parameters observed for scoring were density, area of corneal opacity, iris irritation, conjuctivae redness, lid swelling and discharge of treated eye. The details on the scoring system were not provided in the study report.

CLASSIFICATION OF TEST SUBSTANCE: The criteria used for classification of test substance was as follows:
Non-irritant: 0 or 1 rabbit with positive score during study
Irritant: 4 or more rabbits with positive score
Questionable: 2 or 3 rabbits with positive score. Repeat test indicated.

TOOL USED TO ASSESS SCORE: Not reported

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Day 4-1
Score:
0.16 - 1.34
Reversibility:
not fully reversible within: 4 d
Remarks on result:
other: 100 mg of test substance, Unwashed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Day 4-1
Score:
0.34 - 1.167
Reversibility:
not fully reversible within: 4 d
Remarks on result:
other: 100 mg of test substance, Unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Day 4-1
Score:
1 - 2
Reversibility:
not fully reversible within: 4 d
Remarks on result:
other: 100 mg of test substance, Unwashed
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.6
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.6
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.6
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not specified
Irritant / corrosive response data:
- Treatment related symptoms of corneal opacity, iris irritation, conjuctivae redness, lid swelling and discharge were observed in all animals during the study.
The details on result are provided in the ‘Table 1’ in the section of ‘Any other information on results incl. tables’.

Any other information on results incl. tables

Table 1: Eye irritation observations (Study # 6A050)

Animal

Parameters observed

Days after instillation

1

2

3

4

1

Density

2

2

2

1

Area of corneal opacity

3

2

2

1

Iris irritation

2

2

2

1

Conjuctivae redness

2

2

2

1

Lid swelling

4

4

3

2

Discharge

3

3

3

2

2

Density

2

1

1

0

Area of corneal opacity

1

1

1

0

Iris irritation

1

1

1

1

Conjuctivae redness

2

2

2

1

Lid swelling

4

4

3

2

Discharge

3

3

3

2

3

Density

1

1

1

0

Area of corneal opacity

1

1

1

0

Iris irritation

1

1

1

0

Conjuctivae redness

2

2

2

1

Lid swelling

4

4

4

2

Discharge

3

3

2

1

4

Density

1

1

1

0

Area of corneal opacity

1

1

1

0

Iris irritation

1

1

1

0

Conjuctivae redness

2

2

2

1

Lid swelling

3

3

3

2

Discharge

2

2

2

1

5

Density

1

1

1

0

Area of corneal opacity

1

1

1

0

Iris irritation

1

1

1

0

Conjuctivae redness

2

2

2

1

Lid swelling

4

4

3

2

Discharge

2

2

2

1

6

Density

1

0

0

0

Area of corneal opacity

1

0

0

0

Iris irritation

1

1

1

0

Conjuctivae redness

2

2

2

1

Lid swelling

4

3

3

1

Discharge

2

2

2

1

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
expert judgment
Conclusions:
N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate was found to be irritating when instilled undiluted (without eye rinse) to rabbit’s eye. According to CLP criteria, the registered substance was classified as Category 1 for eye irritation.
Executive summary:

The purpose of this in-vivo eye irritation test was to evaluate eye irritation potential of N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate when applied once to rabbit eye.

Six rabbits (2 male and 4 female) were used in the study. The 100 mg test substance was applied to the left eye of each rabbit. The test substance was not removed after treatment.

The animals were observed for signs of corneal opacity, iris irritation, conjuctivae redness, lid swelling and discharge on Day 1-4 of study.

The signs of irritation were observed on Day 1-4 after treatment.

Based on above, N,N-Bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate was found to be irritating when instilled undiluted (without eye rinse) to rabbit’s eye. According to CLP criteria, the registered substance was classified as Category 1 for eye irritation.