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EC number: 947-655-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1962
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 962
- Report date:
- 1962
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Draize, Calvery and Woodward ( Journ. Pharm. Exp. Therap. 82, 377-390, 1944)
- GLP compliance:
- no
Test material
- Reference substance name:
- Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts
- IUPAC Name:
- Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-18(even numbered) and C18 unsaturated)alkyl)amino]ethyl]esters, disodium salts
- Test material form:
- other: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Not provided
Test system
- Vehicle:
- other: distilled water
- Controls:
- other: London tap water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 20% active matter (except for the proprietary shampoo and the proprietary baby shampoo which were tested at full strength) - Duration of treatment / exposure:
- Test solution was instilled into the conjunctival sac of one eye of each rabbit. No washing was done after instillation.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize scoring method
TOOL USED TO ASSESS SCORE: visually and with the aid of an ophtalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: total cornea score (opacity and area involved)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: total conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.77
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: total conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: total conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- other: total conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: total iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
Any other information on results incl. tables
Table 1. Results Rabbit 3.G : Eye irritation study with [Trade name] (20% active matter)
|
Hours |
Days |
|||||||
|
1 |
2 |
4 |
6 |
24 |
48 |
72 |
4 |
7 |
CORNEA |
|
|
|
|
|
|
|
|
|
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
|
Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
Redness |
2 |
3 |
3 |
3 |
2 |
1 |
0 |
0 |
0 |
Chemosis |
1 |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
Discharge |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
Score |
10 |
14 |
14 |
14 |
8 |
2 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
Total Score |
10 |
14 |
14 |
14 |
8 |
2 |
0 |
0 |
0 |
Table 2. Results Rabbit 3.V : Eye irritation study with [Trade name] (20% active matter)
|
Hours |
Days |
|||||||
|
1 |
2 |
4 |
6 |
24 |
48 |
72 |
4 |
7 |
CORNEA |
|
|
|
|
|
|
|
|
|
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
|
Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
Redness |
2 |
3 |
3 |
3 |
1 |
0 |
0 |
0 |
0 |
Chemosis |
2 |
3 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
Discharge |
2 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
Score |
12 |
16 |
16 |
14 |
2 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
Total Score |
12 |
16 |
16 |
14 |
2 |
0 |
0 |
0 |
0 |
Table 3. Results Rabbit 3.R : Eye irritation study with [Trade name] (20% active matter)
|
Hours |
Days |
|||||||
|
1 |
2 |
4 |
6 |
24 |
48 |
72 |
4 |
7 |
CORNEA |
|
|
|
|
|
|
|
|
|
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
|
Values |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
Redness |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
Chemosis |
2 |
2 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
Discharge |
2 |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
Score |
12 |
12 |
14 |
12 |
4 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
Total Score |
12 |
12 |
14 |
12 |
4 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- mild irritation reversible within 3 days.
- Executive summary:
The objective of the study was to determine the potential eye irritation properties of different samples of which the chemical nature was not disclosed. The method used was generally that of Draize, Calvery and Woodward (Journ. Pharm. Exp. Therap. 82, 377 -390, 1944) and later described in "Appraisal of Safety of Chemicals in Foods, drugs and Cosmetics" (F.D.A. Div. Pharmacology, Draize J.H., 1959). The test solutions were made up by diluting the submitted samples of declared content of active matter with distilled water so that the content of active matter was reduced to 20% in each case. The tap water used for the control was London Tap Water. 0.1mL of the test solution (20% act. ingr.) was instilled into the conjunctival sac of one eye of each rabbit, the other eye serving as a control. In no case was the eye washed after instillation. For the sample of [Trade name], 3 rabbits were used. Readings were made visually and with the aid of an ophthalmoscope at 1, 2, 4, 6, 24, 48, 72 hours and 4 and 7 days after instillation and evaluated according to the Draize scoring method.
For the sample of [Trade name], mild irritation was observed which was reversible within 3 days.
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