Registration Dossier
Registration Dossier
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EC number: 235-920-3 | CAS number: 13047-13-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 March 1985 to 11 June 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one
- EC Number:
- 235-920-3
- EC Name:
- 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one
- Cas Number:
- 13047-13-7
- Molecular formula:
- C11H14N2O2
- IUPAC Name:
- 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one
- Test material form:
- 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: Broekman Institute Someren, The Netherlands
- Weight at study initiation: 2761 - 3000 g
- Housing: individually in Lurane cages with perforated floors
- Diet: standard diet ( LK01 Hope Farms Woerden) 100 g/d
- Water: tap water ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 50-80%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- grounded before instillation
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 64 mg (0.1 mL)
VEHICLE: none
- Duration of treatment / exposure:
- NA
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours and 7 and 14 days after instillation
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: at 24 and 48 h fluorescein staining was used
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
- Remarks on result:
- other: superficial epithelial corrosion of the cornea (10-20%) at 24 h after fluorescein treatment
- Remarks:
- no corneal damage at 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Animal no |
1 |
2 |
3 |
|||||||||||||||
1 |
24 |
48 |
72 |
7 |
14 |
1 |
24 |
48 |
72 |
7 |
14 |
1 |
24 |
48 |
72 |
7 |
14 |
|
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
iris |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness |
1 |
1 |
2 |
2 |
1 |
0 |
1 |
2 |
1 |
1 |
1 |
0 |
1 |
2 |
2 |
1 |
1 |
0 |
chemosis |
3 |
2 |
2 |
1 |
0 |
0 |
2 |
2 |
1 |
1 |
0 |
0 |
3 |
2 |
1 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered non-irritant to the eyes
- Executive summary:
Three female rabbits received 64 mg (0.1 mL) of the substance in the eye. The eyes were observed for signs of irritation after 1, 24, 48 and 72 hours and after 7 and 14 days. No effects were found on the cornea and the iris. The effects on the conjunctivae were limited and fully reversible. The substance is considered not irritating to the eyes.
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