Registration Dossier
Registration Dossier
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EC number: 215-710-8 | CAS number: 1344-95-2
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study based on national guideline, limited documentation, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substance Act: CFR part 191, Chapter I, Title 21, Fed. Register 26, p. 7333, 12 Aug. 1961 / Fed. Regulation, 29, No. 182, p. 13009, 17 Sep. 1964
- GLP compliance:
- no
Test material
- Reference substance name:
- Silicic acid, aluminum sodium salt
- EC Number:
- 215-684-8
- EC Name:
- Silicic acid, aluminum sodium salt
- Cas Number:
- 1344-00-9
- Details on test material:
- - Name of test material (as cited in study report): BR-19
- Substance type: inorganic
- Physical state: solid, white powder
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Analytical data after ignition: SiO2 (62%); Al2O3 (11.6%); Na2O (8.3%) (see Jones 1975)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded (shaved )
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 g as paste
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg silicate - Duration of treatment / exposure:
- 24 h
- Observation period:
- Scoring after 24 and 72 h after test initiation
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: gauze patch, 2 square inch, secured with masking tape
- Type of wrap if used: impervious plastic sheeting around the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h
SCORING SYSTEM: according to Draize scoring system for erythema, edema, and necrosis primary irritation score (maximum score 8)
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0.1
- Max. score:
- 8
- Irritant / corrosive response data:
- No irritation (erythema or edema) was observed (Report, Tab. III).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not irritating (EU and GHS)
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