Registration Dossier
Registration Dossier
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EC number: 201-289-8 | CAS number: 80-54-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to FDA Register 38. No. 187, Para. 1500.41, S27029
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- Study performed according to FDA Register 38. No. 187, Para. 1500.41, S27029
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- EC Number:
- 201-289-8
- EC Name:
- 2-(4-tert-butylbenzyl)propionaldehyde
- Cas Number:
- 80-54-6
- Molecular formula:
- C14H20O
- IUPAC Name:
- 3-(4-tert-butylphenyl)-2-methylpropanal
- Details on test material:
- - Name as cited in document: Lilial
- Analytical purity: 99%
- Batch No.: not reported
- Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- - Source: Gaukler
- Diet: Ssniff (Internast)
- Mean weight at study initiation: 2.8 kg (male), 2.7 kg (female)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: undiluted - Duration of treatment / exposure:
- eye were not washed after application
- Observation period (in vivo):
- 24h, 48h, 72h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24h; 48h; 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24h;48h;72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24h;48h;72h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24h;48h;72h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Summary of results
Cornea |
Iris |
Conjunctiva |
||||||
Readings |
Animal |
Opacity |
Area involved |
Redness |
Swelling |
Discharge |
Further findings |
|
24h |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
0 |
0 |
0 |
1 |
0 |
0 |
||
3 |
0 |
0 |
0 |
1 |
0 |
1 |
||
48h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
1 |
0 |
0 |
||
72d |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Mean (24h-72h) |
1 |
0 |
0 |
0 |
0.5 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0.5 |
0 |
0 |
||
3 |
0 |
0 |
0 |
1 |
0 |
0.5 |
||
Mean (24h-72h) |
all animals |
0 |
0 |
0.7 |
0 |
0.2 |
Slight redness occured in all animals 24 hours after application of substance. 48 hour after instillation, slight redness was present in only 1/3 animals. By the 72nd hour, redness was totally reversible in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Classification: not irritating
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