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EC number: 603-157-9 | CAS number: 12676-29-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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 the test substance used in the study report: Silicone boride oxide
Physical State: White solid
Homogeneity: The test substance appeared to be homogeneous.
Storage: At room temperature
Expiration Date: January 01, 2036
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V.
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 20.8 +/- 1.1
- Housing: Group
- Diet (e.g. ad libitum): Pelleted standard diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days prior to the start of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2°C
- Humidity (%): 30 – 65% (acclimation period)
45 – 65% (pre-test and main study)
- Air changes (per hr): About 10 / hour
- Photoperiod (hrs dark / hrs light): 12/12
DEVIATIONS:
During the acclimation period for animals used for this study the relative humidity in the animal room ranged between 30 – 65 % instead of 45 – 65% for a few hours. This deviation to the study plan, however, did not affect the validity of the study.
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 5, 10, and 25%
- No. of animals per dose:
- Number of animals for the pre-test: 2 females
Number of animals for the main study: 20 females
Number of animals per group: 5 females (nulliparous and non-pregnant) - Details on study design:
- A solubility experiment was performed according to the recommendations given by OECD 429. The highest test item concentration, which could be technically used was a 25% (w/w) suspension in propylene glycol. Vortexing and sonicating and, if required, warming to 37°C, were used to formulate the test item. At higher concentrations, an applicable formulation of the test item was not achieved, neither by the use of other vehicles nor by using additional methods to formulate the test item.
To determine the highest non-irritant test concentration that does not induce signs of systemic toxicity at the same time, a pre-test was performed in two animals. Two mice were treated by topical application to the dorsal surface of each ear with test item concentrations of 10% and 25% (w/w) once daily each on three consecutive days. - Positive control substance(s):
- other: alpha-hexyl cinnamaldehyde dissolved in acetone:olive oil (4:1 v/v)
- Statistics:
- A statistical analysis was conducted on the DPM values, the ear weights, the lymph node weights and the lymph node cell count to assess whether the difference was statistically significant between test item groups and negative control group. For all statistical calculations SigmaStat for Windows (Version 2.0) was used. A One-Way-Analysis-of-Variance was used as statistical method. In case of significant results of the One-Way-ANOVA, multiple comparisons were performed with the Dunnett test. Statistical significance was set at the five per cent level (p < 0.05). The Dean-Dixon-Test was used for identification of possible outliers (performed with Microsoft Excel 2003). Outliers were not identified.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- In this study Stimulation Indices (S.I.) of 1.45, 1.53, and 2.58 were determined with the test item at concentrations of 5, 10, and 25% (w/w) in propylene glycol, respectively. A statistically significant increase in DPM value was obtained in the high dose group in comparison to the vehicle control group (p<0.05) and a dose response was observed. However, none of the obtained S.I.s exceeded the threshold value of 3 for a positive response.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: A statistically significant increase in DPM value was obtained in the high dose group in comparison to the vehicle control group (p<0.05) and a dose response was observed.
Any other information on results incl. tables
Test item concentration |
Group calculation |
||
Mean DPM per animal |
SD |
S.I. |
|
Vehicle (propylene glycol) |
453.9 |
228.7 |
1.00 |
5% Silicone boride oxide |
657.1 |
332.7 |
1.45 |
10% Silicon boride oxide |
692.9 |
111.2 |
1.53 |
25% Silicon boride oxide |
1169.3* |
292.1 |
2.58 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- A statistically significant increase in lymph node cell count was observed in the highest dose group in comparison to the vehicle control group. Still, the cutoff-value of 1.55 for a positive response regarding the lymph node cell count index reported for BALB/c mice was not exceeded in any test item treated group. The lymph node weight did not show a statistically significant increase in comparison to the control group.
The test item Silicone boride oxide was not a skin sensitiser under the test conditions of this study.
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