Registration Dossier
Registration Dossier
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EC number: 603-157-9 | CAS number: 12676-29-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March - April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline- and GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF 8147
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Boron silicate
- EC Number:
- 603-157-9
- Cas Number:
- 12676-29-8
- Molecular formula:
- H7 B7 Si57 O128
- IUPAC Name:
- Boron silicate
- Details on test material:
- Name of test item: silicon boride oxide
Homogeneity: The test item was homogeneous by visual inspection.
Expiry date: January 01, 2036
Storage conditions: Room temperature, protect against humidity
Physical state/ color: Solid / white
pH-value: Approx. 2 (moistened with water)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: approx. 5 months
- Sex: Females
- Weight at study initiation: 3.38 - 3.80 kg
- Housing: Single
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany (ad libitum)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- The solid test item was minimally moistened with a suitable amount of highly deionized water to guarantee skin contact immediately before test-item application.
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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