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EC number: 215-478-8 | CAS number: 1327-43-1
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 27.11.1989-31.01.1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- 112945-52-5
- EC Number:
- 601-216-3
- Cas Number:
- 112945-52-5
- IUPAC Name:
- 112945-52-5
- Details on test material:
- - Name of test material (as cited in study report): Cab-O-Sil EH-5
- Physical state: white powder
- Analytical purity: > 99 %
- Storage condition of test material: room temperature
- Other: The test material was protected from exposure to light.
Constituent 1
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- other: CHO-K1-BH4 (Chinese Hamster Ovary)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ham´s F-12 medium without hypoxanthine supplemented with 5 % dialysed FBS, 1 % penicillin-streptomycin and 1 % L-glutamine (F12FBS5-Hx)
- Periodically checked for Mycoplasma contamination: yes; free of mycoplasma - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix of an Aroclor-1254 (single ip injection of 500 mg/kg bw 5 days prior to sacrifice) induced Sprague-Dawley rat liver homogenate
- Test concentrations with justification for top dose:
- 10, 50, 100, 150, 250 µg/mL: non-activated study
100, 200, 300, 400, 500 µg/mL: activated study - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (Fisher Chemical Company, Springfield, USA)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- growth medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO: final conc. 1 % v/v
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- non-activated study
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- Migrated to IUCLID6: finial conc. 0.2 µL/mL
- Untreated negative controls:
- yes
- Remarks:
- growth medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- activated study
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: final conc. 4 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 5 hours
- Expression time for the phenotype (cells in growth medium): 7-9 days
- Selection time (if incubation with a selection agent): 7 days
SELECTION AGENT (mutation assays): 6-Thioguanine
STAIN (for cytogenetic assays): Giemsa stain, 10 % aqueous
DETERMINATION OF CYTOTOXICITY
- Method: relative cloning efficiency; the cell survival of the test material treated groups was expressed relative to the solvent control. - Evaluation criteria:
- The cytotoxic effects of each treatment condition were expressed relative to the solvent-treated control (relative cloning efficiency).
The mutagenic response after treatment would be considered significant only when the treatment mutant frequency was increased above that of the solvent control and the untreated control by at least 11 mutants per 10E5 clonable cells and also was at least twice that of both the solvent control and the untreated control. - Statistics:
- All calculations were computed using a LOTUS 1-2-3 program on an IBM PC or compatible computer.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: CHO-K1-BH4 (Chinese Hamster Ovary)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >50 µg/mL: cytotoxic effects
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: CHO-K1-BH4 (Chinese Hamster Ovary)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
The medium, the DMSO and the positive controls fulfilled the requirements for a valid test, also in accordance with historical control data.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Under the test conditions, the Cab-O-Sil EH-5 was negative in both the presence and absence of exogenous metabolic activation.
Tab.1 without metabolic activation
treatment [µg/mL] | total mutant colonies | mutants/10E5 clonable cells | survival (relative cloning efficiency) [%] |
medium | 9 | 7.2 | 111 |
DMSO | 1 | 1.0 | 100 |
250 | 0 | <1.2 | 14 |
150 | 0 | <0.9 | 12 |
100 | 1 | 1.0 | 27 |
50 | 10 | 10.3 | 58 |
10 | 9 | 7.3 | 95 |
EMS | 274 | 351.3 | 79 |
Tab.2 with metabolic activation
treatment [µg/mL] | total mutant colonies | mutants/10E5 clonable cells | survival (relative cloning efficiency) [%] |
medium | 1 | 0.8 | 109 |
DMSO | 9 | 8.0 | 100 |
500 | 5 | 4.2 | 56 |
400 | 6 | 6.2 | 50 |
300 | 2 | 1.8 | 66 |
200 | 0 | <0.8 | 95 |
100 | 11 | 8.2 | 111 |
B(a)P | 154 | 184.1 | 11 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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