Registration Dossier
Registration Dossier
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EC number: 212-506-0 | CAS number: 822-89-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 9-March 31, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA FIFRA Pesticide Assessment Guidelines (1984)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydroxyl-2-pyridone
- EC Number:
- 212-506-0
- EC Name:
- Hydroxyl-2-pyridone
- Cas Number:
- 822-89-9
- Molecular formula:
- C5H5NO2
- IUPAC Name:
- 1-hydroxy-1,2-dihydropyridin-2-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): Oxy PYRION
- Physical state: solid (powder)
- Appearance: white speckled gold powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 93100020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, in the original container.
- Stability under test conditions: Stable
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent, England
- Sex: unspecified
- Age at study initiation (in days): Approximately 90 days
- Weight at study initiation: 2.75-3.47 kg
- Housing: Individually housed in stainless cages mounted in mobile batteries. Cages were fitted with perforated counter-sunk floor panels. A tray beneath was lined with absorbant paaper that was changed regularly.
- Diet (e.g. ad libitum): STANRAB pelleted rabbit diet, ad liitum
- Water (e.g. ad libitum): Standard tap water, ad libitum
- Acclimation period: Stated as acclimated, period unspecified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 °C (range 15-23°C)
- Humidity (%): 55% (range 40-70%)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 dark/12 light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 3 x 2 cm
- Type of wrap if used: Covered with an unmedicated gauze patch. Pads of cotton wool and elasticated bandage were used to protect the patches and ensure good contact between the skin and the test material during the four-hour exposure period. The elasticated bandage was held in place by thin strips of waterproof plaster ('Blenderm') at both edges.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with warm water, dried with paper tissues
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours after removal of the bandages
SCORING SYSTEM:
- Draize method
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 as score 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as score 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed on any animal at any time. The control sites did not show any response to the control procedure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test substance was not found to be a skin irritant.
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