Registration Dossier
Registration Dossier
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EC number: 608-211-5 | CAS number: 284462-37-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September to November 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:
- 24 April 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-aminophenoxy)-N-methylpyridine-2-carboxamide
- EC Number:
- 608-211-5
- Cas Number:
- 284462-37-9
- Molecular formula:
- C13 H13 N3 O2
- IUPAC Name:
- 4-(4-aminophenoxy)-N-methylpyridine-2-carboxamide
Constituent 1
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: 3.5-3.8 kg
- Housing: individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding (J. Rettemnaier & Siihne, 73479 Ellwangen-Holzmiihle, Gennany). The wood granulate was changed at least twice weekly.
- Diet: ad libitum, standard diet “Ssniff K-Z” 4mm (manufacturer: Ssniff Spezialdiäten GmbH, 59494 Soest, Germany), approximately 100 g per animal per day
- Water: ad libitum, tap water
- 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 OECD guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 to #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: #1 to #3
- 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
- Conclusions:
- 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 as described in the OECD guideline. The mean irritation indices for erythema and edema were 0 of max. 4. No systemic intolerance reactions were observed.
- Executive summary:
In a primary dermal irritation study according to OECD TG 404 (24 April 2002), three young adult female New Zealand White rabbits were dermally exposed to 0.5 mg/ animal of Picolinamid phenylether moistened with Aqua p.i. for 4 hours. Animals then were observed for 14 days. Irritation was scored by the method described in the OECD test guideline.
No local irritations were observed. In this study, the test item is not a dermal irritant.
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