Registration Dossier
Registration Dossier
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EC number: 635-156-4 | CAS number: 109293-98-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-05-23 until 1995-05-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reliable study, similar to current OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- November, 1984
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium 2-{N-[(3,5-difluorophenyl)carbamoyl]ethanehydrazonoyl}nicotinate
- EC Number:
- 635-156-4
- Cas Number:
- 109293-98-3
- Molecular formula:
- C15 H12 F2 N4 O3 .Na
- IUPAC Name:
- sodium 2-{N-[(3,5-difluorophenyl)carbamoyl]ethanehydrazonoyl}nicotinate
- Reference substance name:
- Diflufenzopyr sodium salt
- IUPAC Name:
- Diflufenzopyr sodium salt
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 9 - 13 weeks
- Weight at study initiation: 2.1 to 2.8 kg
- Housing: individually in metal cages with perforated floors
- Diet: standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: drinking water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°c
- Humidity: 30 - 70 %
- Air changes: 19 air changes per hour
- Photoperiod: 12 hours of artificial light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with 0.5 ml distilled water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48, 72 hours after test substance application
- Number of animals:
- 6 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 100 mm X 100 mm
- Type of wrap if used: "Elastoplast" elastic adhesive dressing on the moistened gauze pads
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean scores of animals 1-6
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.16
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean scores of animals 1-6
- Time point:
- other: 24, 48, 72 hours
- 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
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