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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:
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:
1962
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

Constituent 1
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

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.