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EC number: 407-560-9 | CAS number: 107934-68-9 CAF
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Dec 1987 - 01 Jan 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to guideline study with acceptable restrictions (purity of test substance not specified).
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)
- Version / remarks:
- adopted 12. May 1981
- Deviations:
- yes
- Remarks:
- purity of test substance not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)
- EC Number:
- 407-560-9
- EC Name:
- 4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)
- Cas Number:
- 107934-68-9
- Molecular formula:
- C25H18Cl2N2
- IUPAC Name:
- 4-[9-(4-amino-3-chlorophenyl)-9H-fluoren-9-yl]-2-chloroaniline
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2320 to 2501 g
- Housing: individually in screen-bottom stainless stell cages (heavy gauge)
- Diet: measured amount of Purina High Fiber Rabbit Chow
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 39 - 41
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 29 Dec 1987 To: 01 Jan 1988
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 g (equivalent to 0.1 mL) - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 hours
reading time points: 1, 24, 48 and 72 hours - Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- 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:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Slight conjunctival redness and chemosis (Grade 1) was observed at 1 hour for all animals but was completely reversed in two animals within 24 hours and in the third animal within 48 hours.
- Other effects:
- No pain response was elicited from any animal following instillation of the test material. Blanching of the conjunctivae was observed in one animal at 1 hours.
Any other information on results incl. tables
Table1: Individual Eye Irritation Scores
Cornea |
Iritis |
Conjunctivae Score |
||
Score |
Score |
Redness |
Chemosis |
|
Animal 1 |
||||
1 hour |
0 |
0 |
2 |
1 |
24 hour |
0 |
0 |
1 |
1 |
48 hour |
0 |
0 |
0 |
0 |
72 hour |
0 |
0 |
0 |
0 |
Mean scores (24-72 h) |
0 |
0 |
0,33 |
0,33 |
Animal 2 |
||||
1 hour |
0 |
0 |
1 |
1 |
24 hour |
0 |
0 |
0 |
0 |
48 hour |
0 |
0 |
0 |
0 |
72 hour |
0 |
0 |
0 |
0 |
Mean Scores (24-72 h) |
0 |
0 |
0 |
0 |
Animal 3 |
||||
1 hour |
0 |
0 |
1 |
1 |
24 hour |
0 |
0 |
0 |
0 |
48 hour |
0 |
0 |
0 |
0 |
72 hour |
0 |
0 |
0 |
0 |
Mean scores (24-72 h) |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study with rabbits, performed according to OECD 405 test guideline and GLP principles, no irritation effects on the eye were observed.
- Executive summary:
An eye irritation study was performed according to OECD TG 405 and under GLP conditions. The test item was instillated in one eye of 3 rabbits. One eye remained untreated and served as a control. No irreversible effects were noted.
Based on the results above, the test material is not classified for eye irritation
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