Registration Dossier
Registration Dossier
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EC number: 229-347-8 | CAS number: 6484-52-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- study performed before GLP was in place.
Test material
- Reference substance name:
- Ammonium nitrate
- EC Number:
- 229-347-8
- EC Name:
- Ammonium nitrate
- Cas Number:
- 6484-52-2
- Molecular formula:
- H3N.HNO3
- IUPAC Name:
- ammonium nitrate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): P0018 = Ammonium nitrate
- Physical state: white crystalline solid
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman Ltd., The Field Station, Grimston, Aldbrough, Hull, HU11 4QE
- Weight at study initiation: 2.72-3.23 kg
- Housing: individually in grid floor cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum):free access
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 C
- Humidity (%): 44-53%
- Air changes (per hr): single air conditioned
- Photoperiod (hrs dark / hrs light):14 hours artificial light (06.00-20.00)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 0.5 g moistened with water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: covered with gauze patch and plastic collar around the neck
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towel moistened with water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: 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
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 5
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- P0018 (ammonium nitrate) was regarded as non-irritant to rabbit skin.
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