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EC number: 220-180-6 | CAS number: 2654-57-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 to 20 April 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- data is from experimental reports
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Federal Register Vol 50 no 188, Part II, 27 September 1985
- Version / remarks:
- section 798-4500-Primary Eye Irritation
- Principles of method if other than guideline:
- A study was performed to determine the degree of ocular damage caused by the test chemical in rabbits
- GLP compliance:
- yes
- Remarks:
- report includes a statement by the study director and a QA statement
Test material
- Reference substance name:
- 4-methyl-1-phenylpyrazolidin-3-one
- Cas Number:
- 2654-57-1
- Molecular formula:
- C10H12N2O
- IUPAC Name:
- 4-methyl-1-phenylpyrazolidin-3-one
- Test material form:
- solid
- Details on test material:
- - Name of test material: 3-Pyrazolidinone, 4-methyl-1-phenyl-
- Molecular formula: C10H12N2O
- Molecular weight: 176.219 g/mole
- Smiles: O=C1NN(c2ccccc2)CC1C
- Inchl: InChI=1/C10H12N2O/c1-8-7-12(11-10(8)13)9-5-3-2-4-6-9/h2- 6,8H,7H2,1H3,(H,11,13)/f/h11H
- Substance type: Organic
- Physical state: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Buckmasters, Henham, Hertfordshire, England
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.2-2.6 kg
- Housing: individually in metal cages with perforated floors
- Diet: SDS Standard Rabbit Diet ad libitum
- Water: tap water ad libitum
- Acclimation period: duration not indicated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca 19 °C
- Humidity (%): 30-70%
- Air changes (per hr): ca 19/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL (70 mg)
- Duration of treatment / exposure:
- NA
- Observation period (in vivo):
- after 1 hour and on day 1, 2, 3, 4 and 7
- Number of animals or in vitro replicates:
- 3 males + 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Evaluation of the eyes over a period of 7 days did not show any signs of irritation
Any other information on results incl. tables
Animal no |
1 |
2 |
3 |
||||||||||||||||
1 |
24 |
48 |
72 |
4 |
7 |
1 |
24 |
48 |
72 |
4 |
7 |
1 |
24 |
48 |
72 |
4 |
7 |
|
|
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Animal no |
4 |
5 |
6 |
|
|||||||||||||||
1 |
24 |
48 |
72 |
4 |
7 |
1 |
24 |
48 |
72 |
4 |
7 |
1 |
24 |
48 |
72 |
4 |
7 |
|
|
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
|
chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Evaluation of the eyes over a period of 7 days did not show any signs of irritation. The substance was not irritating to the eyes.
- Executive summary:
In a study similar to OECD 405, 3 male and 3 female New Zealand White rabbits received 0.1 mL of the substance in the eye. Evaluation of the eyes over a period of 7 days did not show any signs of irritation. The substance was not irritating to the eyes.
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