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EC number: 259-134-5 | CAS number: 54381-16-7
Eye irritation
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:
- 1 979
- 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 substance name:
- (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
- EC Number:
- 259-134-5
- EC Name:
- (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
- Cas Number:
- 54381-16-7
- Molecular formula:
- C10H16N2O2.H2O4S
- IUPAC Name:
- (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate
- Reference substance name:
- N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)-p-phenylenediamine sulfate
- 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.
Constituent 1
Constituent 2
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.
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