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Toxicological information

Skin irritation / corrosion

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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:
2004
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

Constituent 1
Chemical structure
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

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.