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EC number: 600-975-8 | CAS number: 110615-47-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Jan - 23 Feb 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
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:
- D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides
- EC Number:
- 600-975-8
- Cas Number:
- 110615-47-9
- Molecular formula:
- Not applicable: UVCB
- IUPAC Name:
- D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: yellow viscous liquid
- Analytical purity: 60% AS
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 2372.5 g (mean)
- Housing: individually in rabbit batteries
- Diet: Altromin-Haltungsdiät 2023 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 21 days
Reading time points: 1, 6, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days - Number of animals or in vitro replicates:
- 4
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days in 1 animal
- Remarks on result:
- other: fully reversible within 7-21 days in 3 animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7-14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 2.1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days in 2 animals
- Remarks on result:
- other: fully reversible within 48 h to 10 days in 2 animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days in 1 animal
- Remarks on result:
- other: fully reversible within 48 h to 10 days in 3 animals
- Other effects:
- No further local or systemic effects were observed.
Any other information on results incl. tables
Table 1. Results of eye irritation study
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
chemosis |
||||
1 |
1 |
1 |
1 |
0 |
1 |
24 |
3 |
2 |
0 |
1 |
|
48 |
3 |
1 |
0 |
1 |
|
72 |
3 |
1 |
1 |
1 |
|
average |
3.00 |
1.33 |
0.33 |
1 |
|
2 |
1 |
1 |
2 |
0 |
1 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
1 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1.33 |
0.67 |
0 |
0 |
|
3 |
1 |
1 |
2 |
0 |
1 |
24 |
3 |
2 |
0 |
1 |
|
48 |
3 |
2 |
1 |
1 |
|
72 |
2 |
1 |
1 |
1 |
|
average |
2.67 |
1.67 |
0.67 |
1 |
|
4 |
1 |
1 |
2 |
0 |
1 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
1 |
0 |
0 |
|
72 |
1 |
1 |
0 |
0 |
|
average |
1.33 |
1.00 |
0 |
0 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average |
1 |
1.00 |
1.75 |
0.00 |
1.00 |
24 |
2.50 |
1.50 |
0.00 |
0.50 |
|
48 |
2 |
1 |
0 |
1 |
|
72 |
2 |
1 |
1 |
1 |
|
24+48+72 |
2.08 |
1.17 |
0.25 |
0.50 |
|
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Eye Dam. 1, H318
DSD: Xi, R41
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