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Registration Dossier
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EC number: 945-205-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 09 Jan 1989 - 03 Feb 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic data given
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:
- other: Federal Register (191, December, 1972)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Zeolite S-D
- Chemical name: Zeolite, silica rich, crystalline, synthetic, non-fibrous
- Framework: orthorhombic
- Related CAS number: 1318-02-1
- Analytical purity: 99.4wt%
- Impurities: 0.79wt% Al203, <0.01% Na2O, 11.6% L0I
- Substance type: white powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.61 - 2.85 kg
- Diet (e.g. ad libitum): solid diet for rabbits (RM-3 feeding); ad libitum
- Water (e.g. ad libitum): water; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- 4, 24, 48 and 96 h after contact with test substance
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: non-irritating tapes (no further details)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): webbed with distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM:
Calculation of Primary Irritation Index from data of erythema and eschar formation (Grade 0 to 4) and edema formation (grade 0 to 4).
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 4, 24, 48 and 96 h
- Score:
- 0
- Remarks on result:
- other: calculated value 0.003
Any other information on results incl. tables
In one of 6 animals very slight erythema (grade 1) occured 48 h after exposure to the test article which was still present after 96 h.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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