Registration Dossier
Registration Dossier
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EC number: 230-262-3 | CAS number: 6994-25-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
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 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
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2426,38 +/- 41 g average weight
- 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:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mg
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Observation period (in vivo):
- 1 h, 24 h, 48h, 72 h, 96 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: congestion
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: congestion
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: congestion
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h, 48h, 72 h, 96 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h, 72 h, 96 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h, 24h,48h,72h,96h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Conjuctivae effect was observed in 3 animals: congestion in all cases.
Conjuctivae symptoms were decreased in the first 24 h.
There were no cornea and iris symptoms.
At 96 h, all the 3 animals were symptom free.
No corneae and no iris change was observed.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the results the substance is slightly irritating to eyes.
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