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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:
guideline study with acceptable restrictions
Remarks:
The study was not performed under GLP,however the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
¨test with 6 animals, 72h observation period
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Test material
- Name of test material (as cited in study report): Surfactant E-196 (80% active)
- Physical state: Not provided, but assumed to be a viscous liquid
- Analytical purity: 80%
- Impurities (identity and concentrations): See confidential details
- 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:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the product as received was introduced into the conjunctival sac


Duration of treatment / exposure:
Not applicable
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Not provided

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
17.6
Max. score:
80
Reversibility:
other: not fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
5
Max. score:
10
Reversibility:
other: not fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
14
Max. score:
20
Reversibility:
other: not fully reversible

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

20

20

20

20

20

20

IRIS

5

5

5

5

5

5

5

CONJUNCTIVAE

14

20

14

20

8

12

15

48

CORNEA

20

20

20

20

20

5

18

IRIS

5

5

5

5

5

5

5

CONJUNCTIVAE

14

14

14

16

8

14

13

72

CORNEA

20

20

15

10

10

5

15

IRIS

5

5

5

5

5

5

5

CONJUNCTIVAE

14

14

16

8

8

14

14

         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.

- inflammation of the iris other than slight deepening of the folds, or slight circumcorneal injection.

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

- 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:
Category I
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This test item is irritating to rabbit eyes. Therefore, precautions should be observed to avoid its introduction into or near the eyes.
Executive summary:

0.1 g Butanedioic acid, sulfo-, 1,4 -dicyclohexyl ester, sodium salt containing 80% active ingredient was introduced into the conjunctival sac of 6 rabbits. Scoring according to Draize et al. (1944) after 24, 48 and 72 hours demonstrated a mean cornea score of 17.6/80, a mean iris score of 5/10 and a mean conjuctivae score of 14/20. 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,inflammation of the iris other than slight deepening of the folds, or slight circumcorneal injection, diffuse, deep-crimson red appearance of the conjunctivae, with individual vessels not easily discernible and obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lids. It was concluded that the test item produces irritation of rabbit eyes. Therefore, precaution should be observed to avoid its introduction into or near the eyes.