Registration Dossier
Registration Dossier
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EC number: 220-150-2 | CAS number: 2643-07-4
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 well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Method:Fed. Register 38, No 187, 27.09.73 (Draize Test)
- GLP compliance:
- no
Test material
- Reference substance name:
- p-[(2-chloroethyl)ethylamino]benzaldehyde
- EC Number:
- 220-150-2
- EC Name:
- p-[(2-chloroethyl)ethylamino]benzaldehyde
- Cas Number:
- 2643-07-4
- Molecular formula:
- C11H14ClNO
- IUPAC Name:
- 4-[(2-chloroethyl)(ethyl)amino]benzaldehyde
- Details on test material:
- N-Ethyl-N-(2-chlorethyl)-p-amino-benzaldehyd (purity > 90 %)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 2.73 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The adjacent eye served as saline control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- unspecified
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- One hour after application of the test substance clear redness of the conjunctivae, slight chemosis and secretion were observed in all animals. The individual mean cornea/iris/conjunctivae/chemosis scores (24, 48, 72 h) were 0/0/1/0, 0/0/1.3/0 and 0/0/1.3/0 for the 3 animals tested. At the end of the observation time (8 d), only slight redness of the conjunctivae was still present in one animal.
Any other information on results incl. tables
Eye readings:
Time |
Animal |
Conjunctivae |
Cornea Opacity |
Iritis |
|
Erythema |
Chemosis |
||||
1 hour |
1 |
2 |
1 |
0 |
0 |
2 |
2 |
1 |
0 |
0 |
|
3 |
2 |
1 |
0 |
0 |
|
24 hours |
1 |
1 |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
|
3 |
2 |
0 |
0 |
0 |
|
48 hours |
1 |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
|
3 |
1 |
0 |
0 |
0 |
|
72 hours |
1 |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
|
3 |
1 |
0 |
0 |
0 |
|
8 days |
1 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Classification: not irritating
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