Registration Dossier
Registration Dossier
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EC number: 238-262-5 | CAS number: 14320-04-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted May 12, 1981)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]zinc
- EC Number:
- 238-262-5
- EC Name:
- [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]zinc
- Cas Number:
- 14320-04-8
- Molecular formula:
- C32 H16 N8 Zn
- Details on test material:
- - Physical state: solid
- Analytical purity: 96.8%
- Batch No.: Partie 77.86
- Stability under test conditions: not determined
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.3-2.4kg
- Housing: singly
- Diet (ad libitum): NAFAG 814
- Water (ad libitum): fresh water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: flanks
- coverage: approx. 12-16 cm2
- Type of wrap if used: A gauze patch with the test article on the right flank and a control gauze patch was applied to the contralateral flank. Both patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (approx. 36 cm) and held in place for 4 hours by an adhesive tape.
SCORING SYSTEM: according to OECD Guideline 404
The animals were checked daily for systemic symptoms and mortality.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours post treatment
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 hours post treatment
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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