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Registration Dossier
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EC number: 245-629-3 | CAS number: 23386-52-9
Eye irritation
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 for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 969
- Report date:
- 1969
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ¨test with 6 animals, 72h observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 1,4-dicyclohexyl sulphonatosuccinate
- EC Number:
- 245-629-3
- EC Name:
- Sodium 1,4-dicyclohexyl sulphonatosuccinate
- Cas Number:
- 23386-52-9
- Molecular formula:
- C16H26O7S.Na
- IUPAC Name:
- sodium 1,4-bis(cyclohexyloxy)-1,4-dioxobutane-2-sulfonate
- 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
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:
- 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
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 20
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 20
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 18.33
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 20
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 16.67
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 10
- Max. score:
- 80
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 14
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 16
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 14.67
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 18
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 8
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 13.33
- Max. score:
- 20
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
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.
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