Registration Dossier
Registration Dossier
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EC number: 603-434-4 | CAS number: 130755-46-3
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:
- other: Guideline study (OECD 404); GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-amino-4-({5-amino-3-cyano-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazol-4-yl}disulfanyl)-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazole-3-carbonitrile
- EC Number:
- 603-434-4
- Cas Number:
- 130755-46-3
- Molecular formula:
- C22 H8 Cl4 F6 N8 S2
- IUPAC Name:
- 5-amino-4-({5-amino-3-cyano-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazol-4-yl}disulfanyl)-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazole-3-carbonitrile
- Details on test material:
- - Name of test material (as cited in study report): Disulfide / MB 46307 / RPA 98028 Intermediate of Fipronil (MB 46030).
- Physical state: yellow powder.
- Analytical purity: 97.2 %.
- Purity test date: 23-May-1995.
- Lot/batch No.: 95-4023.
- Storage condition of test material: The test substance was stored in an air-tight, light-resistant container at room temperature.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Credo, St Germain sur L'Arbresle, 69210, France.
- Weight at study initiation: weight range from 2.8 to 3.1 kg.
- Housing: individually in plastic cages.
- Diet: Certified Pellet diet 112C (Usine d´Alimentation Rationnelle, Villemoisson-sur-Orge, 91360 Epinay-sur-Orge, France) ad libitum.
- Water: filtered and softened water from the municipal water supply, ad libitum.
- Acclimation period: 5 days .
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15°C - 21°C.
- Humidity (%): 40% - 60%.
- Air changes (per hr): 10 to 15 air changes per hour (average, not monitored).
- Photoperiod (hrs dark / hrs light): 12-hour light, 12-hour dark cycles.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 500 mg/animal
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: hydrophilic gauze patch which was secured by a semi-occlusive hypoallergenic dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was gently removed with sterile water.
- Time after start of exposure: 4 h.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: no effects
Any other information on results incl. tables
No mortalities occurred during the course of the study. There were no treatment-related clinical signs or behavioral abnormalities. The body weight evolution of the animals was unaffected by treatment.
No erythema and no edema were observed (score 0 according to the OECD/Draize scheme).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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