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EC number: 614-482-0 | CAS number: 68439-46-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1989
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 68439-45-2
- EC Number:
- 614-481-5
- Cas Number:
- 68439-45-2
- IUPAC Name:
- 68439-45-2
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Ethoxylation degree: 1.4
- Physical state: Clear liquid
- Analytical purity: No data
- Stability under test conditions: Stable
- pH-value: 11.84
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, USA
- Age at study initiation: 3-6 months
- Housing: Individually in suspended, wire bottom, stainless steel cages
- Diet: Purina Rabbit Chow, ad libitum
- Water: Municipal water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72±5
- Humidity (%): 30-80
- Air changes (per hr): 10-12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- One experiment was performed as single application without rinsing
One experiment was performed as single application with rinsing - Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females) without rinsing
3 females with rinsing - Details on study design:
- REMOVAL OF TEST SUBSTANCE:
In one experiment eyes were not rinsed after application.
In the other experiment eyes were rinsed with deionised water for one min 30 sec after application.
SCORING SYSTEM: Eyes were scored at 1, 24, 48 and 72 h and Days 7, 14 and 21 after treatment according to Draize
TOOL USED TO ASSESS SCORE: Fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean (24,48,72 h)
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean (24,48,72 h)
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean (24,48,72 h)
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- other: mean (24,48,72 h)
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- Discharge was observed in each animal at the 1 h reading and resolved latest by day 7.
Any other information on results incl. tables
Table 1. Results of the eye irritation study.
Animal |
Time (h) |
Cornea |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
||||
1 |
1 |
0 |
0 |
3 |
3 |
24 |
1 |
0 |
3 |
2 |
|
48 |
1 |
0 |
3 |
1 |
|
72 |
1 |
0 |
3 |
1 |
|
4d |
0 |
0 |
2 |
0 |
|
7d |
0 |
0 |
1 |
0 |
|
10d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
1.0 |
0 |
3.0 |
1.3 |
|
2 |
1 |
0 |
0 |
3 |
3 |
24 |
1 |
0 |
3 |
1 |
|
48 |
1 |
0 |
2 |
0 |
|
72 |
0 |
0 |
2 |
0 |
|
4d |
0 |
0 |
1 |
0 |
|
7d |
0 |
0 |
0 |
0 |
|
10d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0.7 |
0 |
2.3 |
0.3 |
|
3 |
1 |
0 |
0 |
2 |
3 |
24 |
0 |
0 |
2 |
0 |
|
48 |
1 |
0 |
2 |
0 |
|
72 |
0 |
0 |
2 |
1 |
|
4d |
0 |
0 |
0 |
1 |
|
7d |
0 |
0 |
0 |
0 |
|
10d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0.3 |
0 |
2.0 |
0.3 |
|
4 |
1 |
0 |
0 |
2 |
3 |
24 |
1 |
0 |
3 |
1 |
|
48 |
1 |
0 |
2 |
0 |
|
72 |
1 |
0 |
3 |
0 |
|
4d |
1 |
0 |
2 |
0 |
|
7d |
0 |
0 |
1 |
0 |
|
10d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
1.0 |
0 |
2.7 |
0.3 |
|
5 |
1 |
0 |
0 |
2 |
3 |
24 |
1 |
0 |
2 |
0 |
|
48 |
1 |
0 |
2 |
0 |
|
72 |
0 |
0 |
1 |
0 |
|
4d |
0 |
0 |
0 |
0 |
|
7d |
0 |
0 |
0 |
0 |
|
10d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0.7 |
0 |
1.7 |
0 |
|
6 |
1 |
0 |
0 |
2 |
3 |
24 |
1 |
0 |
2 |
1 |
|
48 |
1 |
0 |
2 |
0 |
|
72 |
0 |
0 |
2 |
0 |
|
4d |
0 |
0 |
2 |
0 |
|
7d |
0 |
0 |
1 |
0 |
|
10d |
0 |
0 |
0 |
0 |
|
Average 24+48+72 |
0.7 |
0 |
2.0 |
0.3 |
|
The mean 24, 48, 72 h scores were lower when the eyes were rinsed 30 sec after application.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: H319, Cat 2
DSD: not classified
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