Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 262-553-6 | CAS number: 60996-20-5
- 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 bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-05-30 - 2017-08-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to an OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- June 2015
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tripotassium hexafluoroaluminate
- EC Number:
- 237-409-0
- EC Name:
- Tripotassium hexafluoroaluminate
- Cas Number:
- 13775-52-5
- Molecular formula:
- AlF6.3K
- IUPAC Name:
- tripotassium hexafluoroaluminate(3-)
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor-supplemented post-mitochondrial fraction (S9 fraction) prepared by CiToxLAB and obtained from the liver of male Wistar rats treated with with phenobarbital and B-naphthoflavone at 80 mg/kg/day by oral gavage for three consecutive days.
- Test concentrations with justification for top dose:
- - Preliminary concentration range finding test (Informatory toxicity test): Based on the available information and the solubility and compatibility test, a 100 mg/mL stock solution was prepared in distilled water, which was diluted in 6 steps by factors of 2, 2.5 and approximately √10. The revertant colony numbers and the inhibition of the background lawn of auxotrophic cells of two of the tester strains (Salmonella typhimurium TA98, TA100) were determined at the concentrations of 5000, 2500, 1000, 316, 100, 31.6 and 10 μg/plate of the test item.
- Test item concentrations in the Mutagenicity tests (Initial Mutation test and Confirmatory Mutation test): Based on the results of the preliminary tests, a 100 mg/mL stock solution was prepared in Distilled water, which was diluted by serial dilutions in several steps to obtain the dosing formulations for lower doses. The maximum test concentration was 5000 μg test item/plate.
Examined concentrations in the Initial Mutation Test were 5000, 1581, 500, 158.1, 50 and 15.81 μg/plate.
Examined concentrations in the Confirmatory Mutation Test were 5000, 1581, 500, 158.1, 50, 15.81 and 5 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Distilled water
- Justification for choice of solvent/vehicle: The solubility of the test item was examined using Distilled water, Dimethyl sulfoxide (DMSO) and N,N-Dimethylformamide (DMF). White homogeneous suspension with quickly sedimentation was observed at 100 mg/mL concentration using DMF. At the same concentration homogeneous suspension with slower sedimentation was detected using Distilled water and DMSO. Due to the better biocompatibility, Distilled water was selected as vehicle (solvent) for the study.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylenediamine [1] and 2-aminoanthracene [2]
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) for the Initial Mutation Test; pre-incubation method fro the Confirmatory Mutation Test
DURATION
- Preincubation period: 20 minutes at 37°C
- Exposure duration: 48 hours (Confirmatory Mutation Test)
- Incubation: 37°C
- Expression time (cells in growth medium): the number of revertants is determined at the end of the exposure time.
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: all revertants per plates are counted
OTHER EXAMINATIONS:
- Other: Visual examination of the plates was performed : precipitation or signs of growth inhibition were recorded and reported. - Rationale for test conditions:
- Concentration selection: Concentrations were selected on the basis of the Preliminary Compatibility Test and Preliminary Concentration Range Finding Test (Informatory Toxicity Test). In the Initial Mutation Test and Confirmatory Mutation Test different concentrations were used.
- Evaluation criteria:
- CRITERIA FOR VALIDITY:
The study was considered valid if:
- the number of revertant colonies of the negative (solvent) and positive controls were in the historical control range in all strains of the main tests;
- at least five analyzable concentrations were presented in all strains of the main tests.
CRITERIA FOR A POSITIVE RESPONSE:
A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurred and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurred in at least one strain with or without metabolic activation.
An increase was considered biologically relevant if:
- the number of reversion was more than two times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA98, TA100 and Escherichia coli WP2 uvrA bacterial strains;
- the number of reversions was more than three times higher than the reversion rate of the negative (solvent) control in Salmonella typhimurium TA1535 and TA1537 bacterial strains.
CRITERIA FOR A NEGATIVE RESPONSE:
The test item was considered to have shown no mutagenic activity in this study if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation. - Statistics:
- No statistical analysis was performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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:
- In the Initial Mutation Test and Confirmatory Mutation Test, the number of revertant colonies did not show any biologically relevant increase compared to the solvent controls. There were no reproducible dose-related trends and there was no indication of any treatment-related effect
Slight precipitate was observed in the Confirmatory Mutation Test in Salmonella typhimurium TA98 strain with and without metabolic activation on the plates at 5000 μg/plate concentration.
Slightly reduced background lawn was detected in the Confirmatory Mutation Tests in Salmonella typhimurium TA98 strain with and without metabolic activation on the plates at 5000 μg/plate concentration. Reduced colony number was detected in the Initial Mutation Test and Confirmatory Mutation Test in Salmonella typhimurium TA1535 strain with metabolic activation at 5000 μg/plate concentration
The
mean values of revertant colony numbers of untreated, negative (solvent) and positive control plates were within the historical control range in all strains; the reference mutagens showed the expected increase in the number of revertant colonies, the viability of the bacterial cells was checked by a plating experiment in each test. At least five analyzable concentrations were presented in all strains of the main tests. The tests were considered to be valid.
Any other information on results incl. tables
Table 1: Summary Table of the Initial Mutation Test
Concentrations
|
Mean values of revertants / Mutation factor (MF) |
Salmonella typhimuriumtester strains |
Escherichia coli |
|||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|||
Untreated control |
Mean |
25.7 |
25.0 |
97.7 |
96.0 |
10.3 |
11.3 |
10.3 |
12.3 |
69.0 |
69.0 |
|
MF |
1.00 |
0.97 |
1.01 |
0.98 |
0.84 |
1.03 |
1.03 |
1.19 |
1.02 |
0.99 |
||
DMSO control |
Mean |
24.7 |
25.3 |
98.0 |
98.3 |
12.3 |
12.7 |
10.7 |
10.7 |
67.7 |
69.0 |
|
MF |
0.96 |
0.99 |
1.02 |
1.00 |
1.00 |
1.15 |
1.07 |
1.03 |
1.00 |
0.99 |
||
Distilled water control |
Mean |
25.7 |
25.7 |
96.3 |
98.0 |
12.3 |
11.0 |
10.0 |
10.3 |
67.3 |
70.0 |
|
MF |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
||
5000 |
Mean |
24.7 |
25.0 |
109.7 |
106.0 |
13.3 |
4.7 |
8.3 |
5.7 |
67.7 |
61.7 |
|
MF |
0.96 |
0.97 |
1.14 |
1.08 |
1.08 |
0.42 |
0.83 |
0.55 |
1.00 |
0.88 |
||
1581 |
Mean |
24.7 |
26.3 |
109.0 |
119.0 |
10.7 |
10.0 |
12.7 |
8.0 |
71.3 |
70.0 |
|
MF |
0.96 |
1.03 |
1.13 |
1.21 |
0.86 |
0.91 |
1.27 |
0.77 |
1.06 |
1.00 |
||
500 |
Mean |
27.0 |
27.7 |
110.3 |
116.0 |
13.7 |
11.7 |
10.7 |
9.3 |
67.7 |
71.0 |
|
MF |
1.05 |
1.08 |
1.15 |
1.18 |
1.11 |
1.06 |
1.07 |
0.90 |
1.00 |
1.01 |
||
158.1 |
Mean |
25.0 |
30.3 |
124.0 |
109.7 |
10.7 |
12.3 |
11.3 |
9.0 |
68.3 |
63.7 |
|
MF |
0.97 |
1.18 |
1.29 |
1.12 |
0.86 |
1.12 |
1.13 |
0.87 |
1.01 |
0.91 |
||
50 |
Mean |
27.0 |
28.7 |
121.0 |
117.7 |
12.3 |
9.3 |
12.3 |
10.0 |
64.0 |
69.3 |
|
MF |
1.05 |
1.12 |
1.26 |
1.20 |
1.00 |
0.85 |
1.23 |
0.97 |
0.95 |
0.99 |
||
15.81 |
Mean |
24.7 |
25.7 |
109.0 |
121.0 |
8.0 |
10.7 |
10.7 |
11.3 |
58.0 |
67.3 |
|
MF |
0.96 |
1.00 |
1.13 |
1.23 |
0.65 |
0.97 |
1.07 |
1.10 |
0.86 |
0.96 |
||
NPD (4mg) |
Mean |
332.7 |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
|
MF |
13.49 |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
||
2AA (2mg) |
Mean |
-- |
2421.3 |
-- |
2376.0 |
-- |
228.7 |
-- |
270.7 |
-- |
-- |
|
MF |
-- |
95.58 |
-- |
24.16 |
-- |
18.05 |
-- |
25.38 |
-- |
-- |
||
2AA (50mg) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
237.3 |
|
MF |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
3.44 |
||
SAZ (2mg) |
Mean |
-- |
-- |
1220.0 |
-- |
1066.7 |
-- |
-- |
-- |
-- |
-- |
|
MF |
-- |
-- |
12.66 |
-- |
86.49 |
-- |
-- |
-- |
-- |
-- |
||
9AA (50mg) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
401.3 |
-- |
-- |
-- |
|
MF |
-- |
-- |
-- |
-- |
-- |
-- |
37.63 |
-- |
-- |
-- |
||
MMS (2mL) |
Mean |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
968.0 |
-- |
|
MF |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
-- |
14.38 |
-- |
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Potassium cryolite is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
- Executive summary:
Potassium cryolite was tested for potential mutagenic activity using the Bacterial Reverse Mutation Assay according to the OECD 471 Guideline and under GLP. The experiments were carried out using four histidine-requiring strains of Salmonella typhimurium (TA 1535, TA 1537, TA 100 and TA 98) and a tryptophan-requiring strain of Escherichia coli WP2uvrA in the presence and absence of a metabolic activation system (phenobarbital/B-naphthoflavone-induced rat liver S9-mix). Based on the results of a solubility test, the test item was formulated in Distilled water.
ln a dose range finding test, the test item was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA98 and TA100. The test item concentrations in the Initial Mutation Test and in the Confirmatory Mutation Test (5 strains) were 5000, 1581, 500, 158.1, 50, 15.81 and 5 (Confirmatory only) μg/plate.
The mean values of revertant colonies of the solvent control plates were within the historical control range, the reference mutagens showed the expected increase in the number of revertant colonies, the viability of the bacterial cells was checked by a plating experiment in each test. At least five analyzable concentrations were presented in all strains of the main tests. The tests were considered to be valid.
Potassium cryolite did not induce a dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA 1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. Based on the results of this study it is concluded that Potassium cryolite is not mutagenic in the Salmonella typhimurium and in the Escherichia coli reverse mutation assay.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.