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EC number: 604-617-1 | CAS number: 147993-66-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22-7-1988 to 19-8-1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted non-GLP, however quality inspections were performed and the study was performed according to valid study methods.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt
- EC Number:
- 604-617-1
- Cas Number:
- 147993-66-6
- IUPAC Name:
- Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Ke 883 B40 ne
- Physical state: White, creamy mass
- Analytical purity: 40%
- 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
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM/Fa
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:Fa. Thomae, Biberach, Germany
- Age at study initiation: Adult (males)
- Weight at study initiation: Average 2482.5 g
- Housing: Individually in rabbit batteries (Fa. Heinkel, 7343 Kuchen/Germany)
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 2023 (Fa. Altromin GmbH/Lage/Germany) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20-21°C
- Humidity (%): ca. 45-55%
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eyes served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g undiluted test item - Duration of treatment / exposure:
- single application, lids were held close briefly
- Observation period (in vivo):
- 10 days after application (Time points: 1, 6, 24, 48 and 72 hours and 7 and 10 days)
- Number of animals or in vitro replicates:
- 4 (males)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein (0.5% fluorescein-sodium-solution )
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.25
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- -All animals showed a slight corneal opacity after 1 to 6 hours after application, which disappeared 7 to 10 days after application.
-One animal had an iris reaction at 24, 48 and 72 hours after application.
-Conjunctival redness was observed in a mild to severe degree and reached its maximum between 24 and 72 hours after application.
-Edema in a mild degree subsided completely in one animal after 24 hours, in the other animals after 7 to 10 days.
-Strong exudation was observed in all animals.
-Conjunctival reactions disappeared completely after 7 to 10 days in all animals.
Corneal damage was observed in all animals 24 hours after application and was confirmed with the help of the fluorescein method. Complete reversibility 7 to 10 days after application was also confirmed with the fluorescein method.
Any other information on results incl. tables
Table 1. Corneal reactions after application of undiluted Ke 833 B40 ne in continuous contact
Animal no. |
Hours after exposure |
|||||||||
1h |
6h |
24h |
48h |
72h |
||||||
A |
B |
A |
B |
A |
B |
A |
B |
A |
B |
|
924 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
802 |
1 |
1 |
1 |
3 |
1 |
3 |
1 |
2 |
1 |
2 |
803 |
0 |
0 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
804 |
1 |
1 |
1 |
2 |
1 |
2 |
1 |
2 |
1 |
2 |
Mean A |
0.75 |
1.00 |
1.00 |
1.00 |
1.00 |
|||||
MeanB |
0.75 |
1.75 |
2.25 |
1.50 |
1.50 |
|||||
Animal no. |
Days after exposure |
|||
7d |
10d |
|||
A |
B |
A |
B |
|
924 |
0 |
0 |
0 |
0 |
802 |
1 |
1 |
0 |
0 |
803 |
0 |
0 |
0 |
0 |
804 |
1 |
1 |
0 |
0 |
Mean A |
0.50 |
0 |
||
MeanB |
0.50 |
0 |
||
A=
opacity
B= area of opacity
Table 2. Corneal reactions in % area of damaged cornea after application of undiluted Ke 833 B40 ne as determined by fluorescein method
Animal no. |
24 h before application |
Days after application |
||
1d |
7d |
10d |
||
924 |
0 |
50 |
0 |
- |
802 |
0 |
50 |
- |
0 |
803 |
0 |
50 |
- |
0 |
804 |
0 |
50 |
- |
0 |
Mean |
0 |
50.0 |
0 |
0 |
Table 3. Iris reactions after application of undiluted Ke 833 B40 ne in continuous contact
Animal no. |
Hours after exposure |
Days after exposure |
|||||
1h |
6h |
24h |
48h |
72h |
7d |
10d |
|
A |
A |
A |
A |
A |
A |
A |
|
924 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
802 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
803 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
804 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
Mean A |
0 |
0 |
0.25 |
0.25 |
0.25 |
0 |
0 |
Table 4. Conjunctivae reactions after
application of undiluted Ke 833 B40 ne in continuous
contact
Animal no. |
Hours after Treatment |
||||||||||||||
1h |
6h |
24h |
48h |
72h |
|||||||||||
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
A |
B |
C |
|
924 |
1 |
1 |
3 |
1 |
1 |
3 |
1 |
0 |
2 |
1 |
0 |
1 |
1 |
0 |
0 |
802 |
1 |
1 |
3 |
1 |
1 |
3 |
3 |
1 |
3 |
3 |
1 |
2 |
3 |
1 |
3 |
803 |
1 |
1 |
3 |
1 |
1 |
3 |
3 |
1 |
3 |
3 |
1 |
3 |
2 |
1 |
1 |
804 |
1 |
1 |
3 |
1 |
1 |
3 |
2 |
1 |
3 |
3 |
1 |
1 |
3 |
1 |
2 |
Mean A |
1.00 |
1.00 |
2.25 |
2.50 |
2.25 |
||||||||||
Mean B |
1.00 |
1.00 |
0.75 |
0.75 |
0.75 |
||||||||||
Mean C |
3.00 |
3.00 |
2.75 |
1.75 |
1.50 |
||||||||||
Animal no. |
Days after Treatment |
|||||
7d |
10d |
|||||
A |
B |
C |
A |
B |
C |
|
924 |
0 |
0 |
0 |
0 |
0 |
0 |
802 |
2 |
0 |
2 |
0 |
0 |
0 |
803 |
0 |
0 |
0 |
0 |
0 |
0 |
804 |
1 |
0 |
1 |
0 |
0 |
0 |
Mean A |
0.75 |
0 |
||||
Mean B |
0 |
0 |
||||
Mean C |
0.75 |
0 |
||||
A=
Redness
B= Chemosis
C= Exudation
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test item containing 40% active ingredient was irritating for the rabbit eyes. .
- Executive summary:
The test item containing 40% active ingredient was tested for primary eye irritation on rabbits by a single application of 0.1 g of the undiluted test item and permanent contact. The reactions on the cornea were slight and disappeared totally within 7 to 10 days. One animal had an irrital reaction between 24 and 72 hours after the application. Mean 24 -72h scores were 1/4 for cornea, 0.25/2 for iris, 2.33/3 for conjunctiva redness and 0.75/4 for chemosis. The conjunctival reactions were moderate to severe and disappeared completely within 7 to 10 days after the application in all animals.
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