Registration Dossier
Registration Dossier
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EC number: 230-262-3 | CAS number: 6994-25-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1986
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The animal test was not followed an appropriate guideline. The test was not performed by a recommended method. The applied test material concentration was not followed the recommendations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Principles of method if other than guideline:
- Test was carried out according to Maguire method, evaluation was carried out according to Kligman recommendations.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Ethyl 3-amino-1H-pyrazole-4-carboxylate
- EC Number:
- 230-262-3
- EC Name:
- Ethyl 3-amino-1H-pyrazole-4-carboxylate
- Cas Number:
- 6994-25-8
- Molecular formula:
- C6H9N3O2
- IUPAC Name:
- ethyl 3-amino-1H-pyrazole-4-carboxylate
- Details on test material:
- Name of test material (as cited in study report): Karbetoxi-pirazol
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance):
- Substance type: organic
- Physical state: white or beige crystalline powder
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other:
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 312.17 +/- 44 g
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h/12h
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 9 days
- Test groups: 10 animals
- Control group: 10 animals
- Site: 1st
- Frequency of applications: 1st day, 2nd day, 4th day Freud adjuvant and exposure, 7th day
- Duration: 9 days
- Concentrations:
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 16th day
- Exposure period: 1 day
- Test groups: 10 animals
- Control group: 10 animals
- Site: 2nd
- Concentrations: 0.2ml, 10 times diluted
- Evaluation (hr after challenge): 24h, 48 h
OTHER: - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 17th day
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- concentrated
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- erythema
- Remarks on result:
- other: Reading: other: 17th day. . Hours after challenge: 24.0. Group: test group. Dose level: concentrated. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: erythema.
- Reading:
- other: 18th day
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- concentrated
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- erythema
- Remarks on result:
- other: Reading: other: 18th day. . Hours after challenge: 48.0. Group: test group. Dose level: concentrated. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: erythema .
- Reading:
- other: 19th day
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- concentrated
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- erythema
- Remarks on result:
- other: Reading: other: 19th day. . Hours after challenge: 72.0. Group: test group. Dose level: concentrated. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: erythema .
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is slight skin sensitiser according to this test result.
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