Registration Dossier
Registration Dossier
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EC number: 608-209-4 | CAS number: 284461-73-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide
- EC Number:
- 608-209-4
- Cas Number:
- 284461-73-0
- Molecular formula:
- C21 H16 Cl F3 N4 O3
- IUPAC Name:
- 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide
- Reference substance name:
- 2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-
- IUPAC Name:
- 2-Pyridinecarboxamide, 4-[4-[[[[4-chloro-3-(trifluoromethyl)phenyl]amino]carbonyl]amino]phenoxy]-N-methyl-
- Reference substance name:
- 4-{ 4-[( {[ 4-chloro-3-(trifluoromethyl)phenyl]amino }carbonyl)amino ]phenoxy }-Nmethyl-2-pyridinecarboxamide
- IUPAC Name:
- 4-{ 4-[( {[ 4-chloro-3-(trifluoromethyl)phenyl]amino }carbonyl)amino ]phenoxy }-Nmethyl-2-pyridinecarboxamide
- Details on test material:
- - Purity not specified
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: female
- Source: Charles River, 88353 Kißlegg, Germany
- Age at study initiation: not specified
- Weight at study initiation: 3.1-3.7 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 60 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: test substance moistened with aqua p.i.
- Controls:
- other: the contralateral untreated skin area served as control
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch, non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: exposed skin area was carefully washed with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to DRAIZE
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- No systemic intolerance reactions were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
In a dermal irritation/corrosion study according to OECD TG 404 the test substance was applied under semiocclusive dressings for 4 hours to the shaved skin of 3 female rabbits. Skin irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. The mean irritation indices for erythema and edema were 0 of max. 4. No systemic intolerance reactions were observed.
According to classification criteria BAY 43-9006 is not an irritant to the skin.
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