Registration Dossier
Registration Dossier
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EC number: 235-920-3 | CAS number: 13047-13-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- last observation at 66 hours after removal of the patch instead of at 72 hours
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute Someren, The Netherlands
- Weight at study initiation: 2810 - 3150 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: not defined
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 55-75%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: skin moistened with 0.5 mL water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL: 0.5 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 66 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: metaline mounted on permeable tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with a water moistened tissue
- Time after start of exposure: at 4 hours
OBSERVATION TIME POINTS: 1, 24, 48 and 66 hours after removal of the dressing
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other:
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- no irritant effects at any of the observations (score 0)
Any other information on results incl. tables
Animal no |
1 |
2 |
3 |
|||||||||
1 |
24 |
48 |
66 |
1 |
24 |
48 |
66 |
1 |
24 |
48 |
66 |
|
erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is non-irrtant to the skin
- Executive summary:
Three female rabbits were exposed to the substance during 4 hours under semi-occlusion. Examination of the skin for signs of oedema and erythema at 1, 24, 48 and 66 hours after removal of the dressing showed no irritation (all scores 0). The substance is non-irritant to the skin.
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