Registration Dossier
Registration Dossier
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EC number: 454-190-9 | CAS number: 324763-51-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- GLP compliance:
- yes
- Remarks:
- Research Institute for Organic Syntheses
Test material
- Details on test material:
- - Physical state: white powder
- Analytical purity: 99.1%
- Lot/batch No.: CHAD 0207
- Storage condition of test material: 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: breeding farm Bio Test, Konárovice
- Age at study initiation: No data
- Weight at study initiation: 3.4 - 3.55 kg
- Housing: individually
- Diet: pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum, made by Bergman, Kocanda Mill
- Water: drinking tap water ad libitum (quality corresponding to Regulation No. 376/2000 Czech Coll. of Law)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21°C
- Humidity (%): 30 - 70 %,
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: close-clipping 24 hours before application
- Vehicle:
- other: moistened with water
- Controls:
- other: untreated skin
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): the test substance was moistened with water pro injections. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 24, 48, 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: no data
- Type of wrap if used: covered by gauze patch, foil and cellulose cotton and held in place with non irritating tape - Spofaplast.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): remaining sample was washed with water
- Time after start of exposure: 4 hours (3 minutes, 1 hour)
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 1 day.
Examination of skin reactions following the single application of the test substance demonstrated that the test substance is not irritating to the skin of rabbits. - Other effects:
- No other signs of intoxication were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU GHS
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