Registration Dossier
Registration Dossier
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EC number: 500-165-3 | CAS number: 66455-14-9 1 - 2.5 moles ethoxylated
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 6 animals used instead of 3
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Alcohols, C12-13, branched and linear, ethoxylated
- EC Number:
- 500-457-0
- EC Name:
- Alcohols, C12-13, branched and linear, ethoxylated
- Cas Number:
- 160901-19-9
- IUPAC Name:
- 160901-19-9
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Breeding center Padre Antonio, Italy
- Weight at study initiation: 2 - 3 kg
- Housing: Stainless steel cages
- Diet (ad libitum): Pelleted complete diet
- Water (ad libitum): Tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 55 +/- 15
- Air changes (per hr): at least 8
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Eyes were not washed.
SCORING SYSTEM:
Draize Scoring
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72, h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
Table 1: Individual scorings
Observation |
Observation time |
Animal No |
|
||||||
1 |
2 |
3 |
4 |
5 |
6 |
Mean |
Men 24, 48, 72 h |
||
Cornea |
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
- |
|
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0.0 |
|
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
7 d |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
- |
Iris |
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
- |
|
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0.0 |
|
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
7 d |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
- |
Redness |
1 h |
2 |
2 |
2 |
2 |
2 |
1 |
1.8 |
- |
|
24 h |
2 |
2 |
1 |
2 |
1 |
1 |
1.5 |
0.83 |
|
48 h |
1 |
1 |
1 |
1 |
1 |
1 |
1.0 |
|
|
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
7 d |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
- |
Chemosis |
1 h |
2 |
2 |
1 |
2 |
1 |
1 |
1.5 |
- |
|
24 h |
1 |
1 |
1 |
1 |
1 |
1 |
1.0 |
0.5 |
|
48 h |
1 |
1 |
1 |
0 |
0 |
0 |
0.5 |
|
|
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
|
7 d |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
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