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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
Study period:
1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted non-GLP, however the study was conducted according to state of the art methods at that time period. The study is considered adequate, reliable and relevant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSA, 16cfr1500.42 CPSC
Deviations:
no
Principles of method if other than guideline:
FHSA: Federal Hazardous Substances Act
CPSC: Consumer Product Safety Commission
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: slightly viscous liquid
Details on test material:
- Name of test material (as cited in study report): Aerosol TR-70 sodium Bis-tridecyl Sulfosuccinate
(70% aqueous solution)
- Physical state: Not provided, but it is assumed that the test material is a slightly viscous liquid
- Analytical purity : 70%
- Impurities (identity and concentrations): Not provided
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- Purity test date: Not provided
- Lot/batch No: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not provided

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL of the product as received was introduced into the conjunctival sac.
Duration of treatment / exposure:
Not provided
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):No

SCORING SYSTEM:
The scoring system used herein for eye irritation reactions is that of Draize, J.H., Woodward,
G., and Calvery, H.O.: J. Pharmacol. Exptl. Therap.82:377, 1944.
The maximum possible scores for eye irritation reactions (again excluding necrosis) are:
Cornea,80; Iris, 10; Conjunctivae, 20.

TOOL USED TO ASSESS SCORE: Not provided

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
14
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
10
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
6.3
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
26.7
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
10
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
20
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3.3
Max. score:
80
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
21.7
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3.3
Max. score:
80
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
5
Max. score:
10
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
9.3
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
12
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
5.3
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.7
Max. score:
20
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4.7
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
9.3
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
12
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
5.3
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.7
Max. score:
20
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4.7
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge
Irritant / corrosive response data:
This product is irritating to the eye of the rabbit. Therefore, precautions should be observed to avoid its introduction into or near the eyes.

Any other information on results incl. tables

Table 1.Rabbit eye irritation results

Time,

Hours

Structure

Rabbit Number, Value

Mean

Value

1

2

3

4

5

6

24

CORNEA

20

10

20

5

30

5

15

IRIS

0

5

0

0

0

0

1

CONJUNCTIVAE

10

12

6

8

8

8

9

48

CORNEA

20

10

20

5

30

5

15

IRIS

0

5

0

0

0

0

1

CONJUNCTIVAE

8

14

6

0

4

4

6

72

CORNEA

40

10

20

0

5

0

12

IRIS

0

5

0

0

0

0

1

CONJUNCTIVAE

10

10

4

0

0

2

4

 At the readings made at 24, 48 and 72 hours, there was:

- discernible opacity or ulceration of the cornea other than a slight dulling of the normal luster.

- no inflammation of the iris other than slight deepening of the folds, or slight circumcorneal injection.

- adiffuse, deep-crimson red appearance of the conjunctivae, with individual vessels not easily discernible.

- an obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lids.

- no destruction or irreversible change of any tissue in 24 hours, or less.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Primary Eye irritation: Moderate Eye Irritation
Did not lessen significantly within 72 hours.
Executive summary:

0.1 g Butanedioic acid, sulfo-, 1,4 -ditridecyl ester, sodium salt (70% active) was introduced into the conjunctival sac of 6 rabbits. Scoring according to Draize et al. (1944) demonstrated a mean cornea score of 14/80, a mean iris score of 1/10 and a mean conjuctiva score of 6.3/20. At the readings made at 24, 48 and 72 hours, there was discernible opacity or ulceration of the cornea other than a slight dulling of the normal luster,adiffuse, deep-crimson red appearance of the conjunctivae, with individual vessels not easily discernible, and an obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lids. It was concluded that the test item containing 70% active ingredient produces  irritation of rabbit eyes. Therefore, precaution should be observed to avoid its introduction into or near the eyes.