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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:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed with a +-45% active ingredient formulation, and not under GLP compliance. However, the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1,2-diisobutoxycarbonylethanesulphonate
EC Number:
204-839-5
EC Name:
Sodium 1,2-diisobutoxycarbonylethanesulphonate
Cas Number:
127-39-9
Molecular formula:
C12H22O7S.Na
IUPAC Name:
sodium 1,4-diisobutoxy-1,4-dioxobutane-2-sulfonate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): AEROSOL® IB, Sodium di-iso-butyl sulfosuccinate
- Physical state: Not provided
- Analytical purity: 44-46 %
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- 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)
Remarks:
part 1 ( in part 2: 50% w/v aqueous dispersion of the product)
Controls:
no
Amount / concentration applied:
Part 1: 0.1g of the product as received
Part 2: 0.1g of a 50% w/v aqueous dispersion of the product
Duration of treatment / exposure:
Not provided
Observation period (in vivo):
24, 48 and 72 hours
Number of animals or in vitro replicates:
6 (part 1)
3 (part 2)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
7.3
Max. score:
80
Reversibility:
not reversible
Remarks on result:
other: product as received
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
10
Reversibility:
not reversible
Remarks on result:
other: product as received
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
7.3
Max. score:
20
Reversibility:
not reversible
Remarks on result:
other: product as received
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
11
Max. score:
80
Reversibility:
not reversible
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48, 72 h
Score:
0
Max. score:
10
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
10.7
Max. score:
20
Reversibility:
not reversible
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
6.67
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.33
Max. score:
80
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
6.67
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
10
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
6.67
Max. score:
80
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: product as received
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
11.67
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: product as received
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: product as received
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: product as received
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: product as received
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: product as received
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
5
Max. score:
10
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
6.67
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
5.33
Max. score:
20
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
7.33
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.67
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
9.33
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: product as received
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
14.67
Max. score:
20
Reversibility:
not reversible
Remarks on result:
other: product as received
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: product as received
Remarks:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: product as received
Remarks:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: product as received
Remarks:
not specified
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
other: product as received
Remarks:
not specified
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
other: product as received
Remarks:
not specified
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
other: product as received
Remarks:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
6.67
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
18.3
Max. score:
80
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
10
Max. score:
80
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
10.67
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
10.67
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
11.33
Max. score:
20
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Remarks:
not specified
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Remarks:
not specified
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: 50% w/v aqueous dispersion of product
Remarks:
not specified

Any other information on results incl. tables

Table1. Scores part 1 (test material as such)

Time,

Hours

Reaction

Rabbit number, Value

Mean

Value

1

2

3

4

5

6

24

Cornea

10

5

10

15

20

15

12

Iris

0

0

0

0

0

5

1

Conjunctivae

10

10

10

4

14

14

10

48

Cornea

5

5

5

10

0

15

7

Iris

0

0

0

0

0

5

1

Conjunctivae

6

6

10

2

12

14

8

72

Cornea

5

0

5

5

0

5

3

Iris

0

0

0

0

0

5

1

Conjunctivae

4

0

2

2

2

16

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.

- a diffuse, 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 lid.

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

Table 2. Scores part 2 (50% w/v aqueous dispersion of the product)

Time,

Hours

Reaction

Rabbit number, Value

Mean

Value

1

2

3

4

5

6

24

Cornea

10

20

20

-

-

-

17

Iris

0

0

0

-

-

-

0

Conjunctivae

12

12

12

-

-

-

12

48

Cornea

5

20

5

-

-

-

10

Iris

0

0

0

-

-

-

0

Conjunctivae

12

10

12

-

-

-

11

72

Cornea

5

15

5

-

-

-

8

Iris

0

0

0

-

-

-

0

Conjunctivae

8

10

10

-

-

-

9

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.

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

- no 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:
This test item is sufficiently irritating to the rabbit eye so that precautions should be observed to avoid its introduction into or near the eyes.
Executive summary:

An in vivo eye irritation study was conducted with a first phase where 6 rabbits received 0.1 g test item containing 44 -46% active ingredient in one eye as an aqueous paste. Scoring at 24, 48 and 72 hours demonstrated non-reversible scores for cornea and conjunctivae in all animals and iris changes in one animal, all not reversible within 72 hours. Mean 24 -72h scores for cornea, conjuctiva and iris were 7.3/80, 7.3/20 and 1/10, respectively. There was no destruction or irreversible change of any tissue in 24 hours,but discernible opacity or ulceration of the cornea, diffuse, deep-crimson red appearance of the conjunctivae and obvious swelling of the conjunctivae with partial eversion of the lid were observed. In a second part of the study, 3 rabbits received 0.1 g as a 50% dilution of the above test item (22 -23% active ingredient). Scoring at 24, 48 and 72 hours demonstrated non-reversible scores in all 3 animals for cornea and conjunctivae, not reversible within 72 hours. Mean 24 -72h scores for cornea, conjuctiva and iris were 11/80, 10.7/20 and 0/10, respectively.

There was no destruction or irreversible change of any tissue in 24 hours, but discernible opacity or ulceration of the cornea, and diffuse, deep-crimson red appearance of the conjunctivae were observed.