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EC number: 913-353-9 | CAS number: -
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Furthermore, a well-conducted (equivalent protocol compared to relevant OECD guideline) chromosome aberration study is available (Pharmakon Research International, 1991b).
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: : GLP compliant study performed to a method equivalent to the relevant guidelines, well conducted, no limitations in reporting and fully adequate for assessment
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
- Remarks:
- The read-across can be performed because trisodium hexafluoroaluminate is component parts of RAL 3.0, and is the only component with possible negative effects for human health
Reference
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Remarks:
- Furthermore, a well-conducted (equivalent protocol compared to relevant OECD guideline) chromosome aberration study is available (Pharmakon Research International, 1991b).
- Adequacy of study:
- weight of evidence
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- GLP compliant study performed to a method equivalent to the relevant guidelines, well conducted, no limitations in reporting and fully adequate for assessment
- Reason / purpose for cross-reference:
- read-across source
- Remarks:
- The read-across can be performed because trisodium hexafluoroaluminate is component parts of RAL 3.0, and is the only component with possible negative effects for human health.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosomal Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Specific details on test material used for the study:
- Kryocide, Lot #86-12, was received by Pharmakon Research International, Inc. Fifty grams of the test article were submitted with the physical description of a white powder.
For the purposes of this study, the test article was stored at room temperature in the container received from the sponsor. All required dilutions
were prepared in water just prior to dosing. At the time of testing, Kryocide was described as a white powder, hence, there was no apparent change in its physical state during the storage. - Species / strain / cell type:
- lymphocytes:
- Remarks:
- human
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9-mix
- Test concentrations with justification for top dose:
- 1, 5, 25, 50, 75, 100, 175, 250, 500 and 1000 µg/ml
- Vehicle / solvent:
- HPLC Grade Water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin C and cyclophosphamide
- Details on test system and experimental conditions:
- Kryocide was evaluated for cytotoxicity in human lymphocyte cultures utilizing cell proliferation kinetics and mitotic index (MI) as parameters. Whole human venous blood was drawn aseptically from a healthy donor. Kryocide was evaluated doses of 1, 5, 25, 50, 75, 100, 175, 250, 500 and 1000 in rat hepatocytes at dose levels up to 1000 µg/ml with and without an exogenous metabolic activation system (S9 mix). Concurrent untreated and solvent (HPLC Grade Water) controls were also evaluated. Based on the cytogenetic findings, the doses selected for the chromosome aberration assay were 100, 500 and 1000 µg/ml. Duplicate cultures of whole blood from the same donor were used for each test point.
Human lymphocytes were exposed to Kryocide at three different phases of the cell cycle (G0/G1, 2 and S) after lymphocytic culture initiation. Each set of cultures was harvested at the appropriate scheduled time. The slides were prepared for metaphase analysis according to standard methods. Fifty (50) metaphases were scored from each culture and data from duplicate cultures pooled for analysis. Treatment times were analyzed separately. - Evaluation criteria:
- Assessment of a test article as positive is based upon its ability to produce a statistically significant increase in the frequency of chromosomal aberration in test cultures as compared to the solvent control and/or a dose response pattern
- Statistics:
- Chi-square analysis was done comparing each data point to its concurrent solvent control. Statistically significant differences in aberrations/cell were determined by pooling the data from the two cultures per data point and conductin g one-tailed t tests comparing treated cultures with their concurrent solvent controls.
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- 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:
- The results of the cytotoxicity evaluation indicated that Kryocide did not result in a significant increase in APT or a significant mitotic depression at any dose evaluated. Therefore, based on these results, 100, 500 and 1000 µg/ml were selected to be evaluated in the human lymphocyte assay with and without S9 mix at the G0/G1, G2 and S phases.
Treatment with Kryocide at 100, 500 and 1000 µg/ml with and without S-9 mix induced no statistically significant increases in aberrations/cell or proportion of aberrant metaphases at any dose level tested - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- After performing chromosome aberration study in mammalian cells no adverse effect observed (negative).
RAL 3.0 is not harmful. - Executive summary:
After performing chromosome aberration study in mammalian cells no adverse effect observed (negative).
RAL 3.0 is not harmful.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
Reference
- Name:
- Unnamed
- Type:
- impurity
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Cryolite
- Substance type: slighty coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6%, F 53.3%
- Storage condition of test material: room temperature
- Specific details on test material used for the study:
- Kryocide, Lot #86-12, was received by Pharmakon Research International, Inc. Fifty grams of the test article were submitted with the physical description of a white powder.
For the purposes of this study, the test article was stored at room temperature in the container received from the sponsor. All required dilutions
were prepared in water just prior to dosing. At the time of testing, Kryocide was described as a white powder, hence, there was no apparent change in its physical state during the storage
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat S9-mix
- Test concentrations with justification for top dose:
- 1, 5, 25, 50, 75, 100, 175, 250, 500 and 1000 µg/ml
- Vehicle / solvent:
- HPLC Grade Water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin C and cyclophosphamide
- Details on test system and experimental conditions:
- Kryocide was evaluated for cytotoxicity in human lymphocyte cultures utilizing cell proliferation kinetics and mitotic index (MI) as parameters. Whole human venous blood was drawn aseptically from a healthy donor. Kryocide was evaluated doses of 1, 5, 25, 50, 75, 100, 175, 250, 500 and 1000 in rat hepatocytes at dose levels up to 1000 µg/ml with and without an exogenous metabolic activation system (S9 mix). Concurrent untreated and solvent (HPLC Grade Water) controls were also evaluated. Based on the cytogenetic findings, the doses selected for the chromosome aberration assay were 100, 500 and 1000 µg/ml. Duplicate cultures of whole blood from the same donor were used for each test point.
Human lymphocytes were exposed to Kryocide at three different phases of the cell cycle (G0/G1, 2 and S) after lymphocytic culture initiation. Each set of cultures was harvested at the appropriate scheduled time. The slides were prepared for metaphase analysis according to standard methods. Fifty (50) metaphases were scored from each culture and data from duplicate cultures pooled for analysis. Treatment times were analyzed separately. - Evaluation criteria:
- Assessment of a test article as positive is based upon its ability to produce a statistically significant increase in the frequency of chromosomal aberration in test cultures as compared to the solvent control and/or a dose response pattern.
- Statistics:
- Chi-square analysis was done comparing each data point to its concurrent solvent control. Statistically significant differences in aberrations/cell were determined by pooling the data from the two cultures per data point and conductin g one-tailed t tests comparing treated cultures with their concurrent solvent controls.
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- 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:
- The results of the cytotoxicity evaluation indicated that Kryocide did not result in a significant increase in APT or a significant mitotic depression at any dose evaluated. Therefore, based on these results, 100, 500 and 1000 µg/ml were selected to be evaluated in the human lymphocyte assay with and without S9 mix at the G0/G1, G2 and S phases.
Treatment with Kryocide at 100, 500 and 1000 µg/ml with and without S-9 mix induced no statistically significant increases in aberrations/cell or proportion of aberrant metaphases at any dose level tested. - Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- RAL 3.0 is not dangerous related to genetic toxicology.
No adverse effect observed (negative) - Executive summary:
After performing chromosome aberration study in mammalian cells no adverse effect observed (negative).
RAL 3.0 is not harmful.
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