Registration Dossier
Registration Dossier
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EC number: 201-899-4 | CAS number: 89-33-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 5-oxo-1-phenyl-2-pyrazoline-3-carboxylate
- EC Number:
- 201-899-4
- EC Name:
- Ethyl 5-oxo-1-phenyl-2-pyrazoline-3-carboxylate
- Cas Number:
- 89-33-8
- Molecular formula:
- C12H12N2O3
- IUPAC Name:
- ethyl 5-oxo-1-phenyl-4,5-dihydro-1H-pyrazole-3-carboxylate
- Details on test material:
- purity: 99.7 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventionell breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 1.9 - 2.6 kg
- Housing: single cages located in completely air conditioned rooms
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, Altromin-GmbH, Lage/Lippe, ad libitum plus 15 g hay per day
- Water. deinized and chlorinated water from automatic dispensors, ad libitum)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+- 20
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- 500 mg test substance suspended with 0.4 ml 0.9% NaCl-solution
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100
- Type of wrap if used: semiocclusive bind
REMOVAL OF TEST SUBSTANCE
- Washing: slighly warm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
erythema: 0 - 4
edema: 0 - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 30 - 60 min after removal of the plaster
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 30 - 60 min after removal of the plaster
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this test the substance is considered as not irritating to the skin.
- Executive summary:
The substance was tested for skin irritation according to OECD Guideline 404. 500 mg of the substance were suspended with physiologic saline solution. This suspension were administered to the abraded skin of 3 rabbits and fixed with a semiocclusive bind.
After 4 hours the substance was removed by washing and the edema and erythem scores were determined. Both scores were 0.
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