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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 620-341-4 | CAS number: 61358-25-6
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 - 30 Nov 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2012
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:
- other: Konpoan No. 287 – Environment Protection Agency
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Eisei No. 127 – Ministry of Health and Welfare
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Heisei 09/10/31 Kikyoku No. 2 – Ministry of Economy, Trade and Industry
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- bis(4-tert-butylphenyl)iodanium; hexafluoro-λ⁵-phosphanuide
- EC Number:
- 620-341-4
- Cas Number:
- 61358-25-6
- Molecular formula:
- C20H26F6IP
- IUPAC Name:
- bis(4-tert-butylphenyl)iodanium; hexafluoro-λ⁵-phosphanuide
- Details on test material:
- - Name of test material (as cited in study report): PF-6
- Analytical purity: > 98%
- Purity test date: 2010-08-12
- Lot/batch No.: 2010 1020
- Expiration date of the lot/batch: 2012-04-12
- Storage condition of test material: at room temperature
Constituent 1
Method
- Target gene:
- his operon (S. typhimurium) and trp operon (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers rats induced with 80 mg/kg bw (i.p.) phenobarbital and peroral administrations of β-naphthoflavone, each on 3 consecutive days
- Test concentrations with justification for top dose:
- Pre-experiment (experiment I): 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate with and without metabolic activation
Experiment II: 0.1#, 0.3, 1, 3, 10, 33, 100, 333 and 1000# µg/plate with and without metabolic activation
#this additional concentrations were used for treatments in the absence of S9 only - Vehicle / solvent:
- - Vehicle/solvent used: DMSO (100 µL)
- Justification for choice of solvent/vehicle: the solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (10 µg/plate, -S9, TA 100 and TA 1535); 4-nitro-o-phenylene-diamine (10 or 50 µg/plate: TA 98 or TA 1537, -S9); methyl methane sulfonate (3 µL/plate, -S9, WP2 uvrA); 2-aminoanthracene (2.5 and 10 µg/plate: all strains, +S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION 1: in agar (plate incorporation) for the pre-experiment (experiment I)
DURATION
- Exposure duration: 48 h
METHOD OF APPLICATION 2: preincubation method for experiment II
DURATION
- Preincubation period: 1 h
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of the bacterial background lawn and count of the number of revertants - Evaluation criteria:
- The test substance was considered to be mutagenic if the following criteria were met:
1) the assay was acceptable (regular background growth in the negative and solvent controls; spontaneous reversion rates in the negative and solvent controls are in the normal ranges of historical data; the positive control chemicals induced significant increases in mutant colony frequencies)
2) the increase in the number of revertants of the test strains compared to the colony counts of the solvent controls was biologically relevant (2-fold increases over controls for TA 98, TA 100, and WP2 uvrA and 3-fold increases over controls for TA 1535 and TA 1537)
3) the data sets showed a biologically relevant dose correlation (thresholds for the fold increase in the number of revertants compared to controls were exceeded at more than one concentration)
4) increases exceeding the threshold at only one concentration were considered biologically relevant, if they were reproduced in an independent second experiment
5) dose dependent increases in the number of revertant colonies below the threshold were regarded as an indication of a mutagenic potential if reproduced in an independent second experiment (such increases were not considered biologically relevant, if colony counts of the treated samples remained within the historical range of the negative and solvent controls) - Statistics:
- Mean values and standard deviations for revertant colonies were calculated.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- plate incorporation (- and +S9): ≥ 33 µg/plate (TA 1537), ≥ 100 µg/plate (TA 1535, TA 98 and TA 100); preincubation (- and +S9): ≥ 10 µg/plate (TA 1537), ≥ 100 µg/plate (TA 1535, TA 98 and TA 100)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- plate incorporation (+ and -S9): ≥ 333 µg/plate; preincubation (-S9): ≥ 100 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: in experiment 1 (plate incorporation), precipitation of the test substance was observed on all incubated plates treated at 2500 and 5000 µg/plate (maximum concentration). In experiment 2 (preincubation), precipitation of the test substance was observed on plates treated at 1000 µg/plate (maximum concentration). The undissolved particles had no influence on data recording.
RANGE-FINDING/SCREENING STUDIES:
Experiment I served as pre-experiment for the assessment of toxicity, using final concentrations of the test substance at 3-5000 µg/plate with or without metabolic activation, plus negative, solvent and positive controls. Following these treatments, strong toxic effects were seen as shown by thinning of the background bacterial lawn and a reduction in the number of spontaneous revertants at higher concentrations. Thus, the maximum concentrations chosen for incubation in the absence or presence of metabolic activation were 333 or 1000 µg/plate, respectively.
COMPARISON WITH HISTORICAL CONTROL DATA:
The mean numbers of spontaneous revertants in the negative, solvent and positive controls of the strains used were all within the normal historical ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the plate incorporation assay (experiment I), cytotoxicity (reduced background lawn and reduced number of revertants) was observed in all strains tested, ranging from 33 up to 5000 µg/plate with or without metabolic activation, respectively. In the preincubation assay (experiment II), cytotoxicity (reduced background lawn and reduced number of revertants) occurred in all strains of S. typhimurium at concentrations ranging from 10 to 333 µg/plate in the absence or 33 to 1000 µg/plate in the presence of metabolic activation. In the E. coli strain WP2 uvrA, cytotoxicity was observed at concentrations ≥ 333 µg/plate in the plate incorporation experiment with and without metabolic activation. In the E. coli strain WP2 uvrA, cytotoxicity was observed at concentrations ≥ 333 µg/plate in the plate incorporation experiment with and without metabolic activation. In contrast, cytotoxicity was only seen without metabolic activation in the preincubation experiment at concentrations ≥ 100 µg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Test results of experiment I (plate incorporation)
PF-6: Bacterial Reverse Mutation Assay, mean revertant colonies/plate (n=3 ± SD) |
|||||
EXPERIMENT I (plate incorporation) |
|||||
S9-Mix |
Without
|
||||
Concentration (per plate) |
TA 1535 |
TA1537 |
TA98 |
TA100 |
E.coli WP2 uvrA |
SC |
13 ± 5 |
21 ± 5 |
34 ± 2 |
104 ± 6 |
51 ± 10 |
NC |
15 ± 5 |
24 ± 2 |
31 ± 8 |
121 ± 3 |
50 ± 4 |
PF-6 |
|
|
|
|
|
3 µg |
14 ± 5 |
22 ± 2 |
26 ± 6 |
90 ± 9 |
42 ± 9 |
10 µg |
12 ± 6 |
24 ± 4 |
31 ± 8 |
104 ± 10 |
42 ± 5 |
33 µg |
10 ± 4 |
13 ± 2M, R |
27 ± 5 |
92 ± 13 |
52 ± 14 |
100 µg |
1 ± 1R |
1 ± 1M, R |
5 ± 2M, R |
12 ± 3M,R |
31 ± 3 |
333 µg |
1 ± 1R |
1 ± 1M, R |
1 ± 1M, R |
1 ± 1M, R |
2 ± 1R |
1000 µg |
0 ± 0R |
0 ± 0M, R |
0 ± 0M, R |
0 ± 0M, R |
0 ± 1R |
2500 µg |
0 ± 0R, P |
0 ± 0P, M, R |
0 ± 0P, M, R |
0 ± 0P, M, R |
0 ± 0P, R |
5000 µg |
0 ± 0R, P |
0 ± 0P, M, R |
0 ± 0P, M, R |
0 ± 0P, M, R |
0 ± 0P, R |
PC |
|
|
|
|
|
NaN3 (10 µg) |
1810 ± 21 |
- |
- |
1972 ± 33 |
- |
4NOPD (10 µg) |
- |
- |
342 ± 17 |
- |
- |
4NOPD (50 µg) |
- |
87 ± 15 |
- |
- |
- |
MMS (3 µL) |
- |
- |
- |
- |
1270 ± 74 |
S9-Mix
|
With |
||||
Concentration (per plate) |
TA 1535 |
TA1537 |
TA98 |
TA100 |
E.coli WP2 uvrA |
NC |
20 ± 5 |
24 ± 3 |
37 ± 9 |
122 ± 8 |
61 ± 6 |
SC |
20 ± 2 |
24 ± 5 |
54 ± 8 |
110 ± 11 |
60 ± 5 |
PF-6 |
|
|
|
|
|
3 µg |
22 ± 1 |
17 ± 2 |
38 ± 4 |
120 ± 23 |
54 ± 10 |
10 µg |
22 ± 2 |
26 ± 4 |
44 ± 7 |
119 ± 7 |
50 ± 11 |
33 µg |
19 ± 5 |
35 ± 7 |
36 ± 3 |
145 ± 19 |
53 ± 3 |
100 µg |
8 ± 2 |
7 ± 2M, R |
28 ± 1 |
116 ± 21 |
59 ± 5 |
333 µg |
1 ± 1R, M |
1 ± 1M, R |
2 ± 1M, R |
8 ± 1R |
8 ± 3M, R |
1000 µg |
1 ± 1R, M |
0 ± 0M, R |
0 ± 0M, R |
1 ± 1R |
0 ± 0M, R |
2500 µg |
0 ± 0P, R, M |
0 ± 0P, M, R |
0 ± 0P, M, R |
0 ± 0P, M, R |
0 ± 0P, M, R |
5000 µg |
0 ± 0P, R, M |
0 ± 0P, M, R |
0 ± 0P, M, R |
0 ± 0P, M, R |
0 ± 0P, M, R |
PC |
|
|
|
|
|
2AA (2.5 µg) |
415 ± 22 |
348 ± 10 |
2109 ± 253 |
2728 ± 35 |
- |
2AA (10 µg) |
- |
- |
- |
- |
237 ± 16 |
NC = Negative Control; SC = Solvent control; PC = Positive control substances; SD = standard deviation; NaN3 = sodium azide; 4NOPD = 4-nitro-o-phenylene-diamine; MMS = methyl methane sulfonate; 2AA = 2-aminoanthracene M = Manual count; P = Precipitate; R = Reduced background growth |
Table 2. Test results of experiment II (pre-incubation)
PF-6: Bacterial Reverse Mutation Assay, mean revertant colonies/plate (n=3 ± SD) |
|||||
EXPERIMENT II (pre-incubation) |
|||||
S9-Mix |
Without
|
||||
Concentration (per plate) |
TA 1535 |
TA1537 |
TA98 |
TA100 |
E.coli WP2 uvrA |
SC |
15 ± 6 |
14 ± 3 |
28 ± 4 |
115 ± 7 |
39 ± 6 |
NC |
11 ± 4 |
11 ± 6 |
34 ± 5 |
137 ± 19 |
35 ± 0 |
PF-6 |
|
|
|
|
|
0.1 µg |
14 ± 2 |
13 ± 1 |
31 ± 6 |
112 ± 1 |
33 ± 8 |
0.3 µg |
14 ± 7 |
15 ± 3 |
26 ± 6 |
93 ± 15 |
39 ± 6 |
1 µg |
13 ± 2 |
16 ± 2 |
30 ± 9 |
106 ± 14 |
33 ± 3 |
3 µg |
15 ± 3 |
16 ± 2 |
33 ± 4 |
111 ± 5 |
35 ± 6 |
10 µg |
17 ± 3 |
8 ± 1M, R |
27 ± 6 |
99 ± 14 |
42 ± 4 |
33 µg |
12 ± 2 |
6 ± 1M, R |
24 ± 4 |
74 ± 6 |
45 ± 2 |
100 µg |
1 ± 1M, R |
0 ± 0M, R |
6 ± 2M, R |
15 ± 3M, R |
8 ± 2M, R |
333 µg |
0 ± 0M, R |
0 ± 0M, R |
0 ± 0M, R |
0 ± 0M, R |
0 ± 1M, R |
PC |
|
|
|
|
|
NaN3 (10 µg) |
1981 ± 77 |
- |
- |
2264 ± 48 |
- |
4NOPD (10 µg) |
- |
- |
353 ± 8 |
- |
- |
4NOPD (50 µg) |
- |
96 ± 18 |
- |
- |
- |
MMS (3 µL) |
- |
- |
- |
- |
537 ± 34 |
S9-Mix
|
With |
||||
Concentration (per plate) |
TA 1535 |
TA1537 |
TA98 |
TA100 |
E.coli WP2 uvrA |
NC |
20 ± 4 |
23 ± 4 |
41 ± 7 |
118 ± 22 |
53 ± 9 |
SC |
25 ± 6 |
22 ± 0 |
42 ± 10 |
134 ± 13 |
42 ± 5 |
PF-6 |
|
|
|
|
|
0.3 µg |
22 ± 2 |
21 ± 1 |
47 ± 3 |
114 ± 15 |
49 ± 8 |
1 µg |
22 ± 1 |
23 ± 4 |
39 ± 10 |
119 ± 1 |
50 ± 12 |
3 µg |
21 ± 4 |
18 ± 3 |
44 ± 10 |
126 ± 9 |
49 ± 7 |
10 µg |
23 ± 3 |
25 ± 2 |
40 ± 4 |
119 ± 4 |
50 ± 5 |
33 µg |
13 ± 1 |
20 ± 3M, R |
38 ± 9 |
104 ± 22 |
54 ± 15 |
100 µg |
10 ± 4 |
3 ± 1M, R |
26 ± 7 |
40 ± 9M, R |
51 ± 6 |
333 µg |
0 ± 0R |
0 ± 0M, R |
0 ± 0R |
0 ± 0M, R |
4 ± 1 |
1000 µg |
0 ± 0R, P |
0 ± 0M, R, P |
0 ± 0RP |
0 ± 0P, M, R |
0 ± 0P |
PC |
|
|
|
|
|
2AA (2.5 µg) |
351 ± 21 |
181 ± 18 |
1677 ± 121 |
2089 ± 153 |
- |
2AA (10 µg) |
- |
- |
- |
- |
203 ± 20 |
NC = Negative Control; SC = Solvent control; PC = Positive control substances; SD = standard deviation; NaN3 = sodium azide; 4NOPD = 4-nitro-o-phenylene-diamine; MMS = methyl methane sulfonate; 2AA = 2-aminoan-thracene M = Manual count; P = Precipitate; R = Reduced background growth |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance did not induce mutations in the bacterial mutation tests in the absence and presence of metabolic activation in the selected strains of S. typhimurium (TA 98, TA 100, TA 1535 and TA 1537) and E. coli (WP2 uvrA). - Executive summary:
A bacterial gene mutation assay (Ames test) was conducted with PF6 according to OCED guideline 471 and under conditions of GLP. The assay included two series of experiments, both performed in the absence and in the presence of S9 mix. In the first experiment, the direct plate incorporation procedure was conducted with Salmonella typhimurium TA 98, TA 100, TA 1535 and TA 1537 and Escherichia coli WP2 uvrA at concentrations ranging from 3 to 5000 µg/plate for a period of 48 h. In the second experiment, concentrations ranging from 0.1 to 333 µg/plate without S9 mix and 0.3 to 1000 µg/plate with S9 mix were analysed using the same strains, but with modification of the study design (with pre-incubation period of 1 h). Cytotoxicity was observed in both independent experiments, as shown by a reduction in background growth at ≥ 10 µg/plate in S. typhimurium and at ≥ 100 µg/plate in E. coli. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains with and without metabolic activation. The positive and negative controls included showed the expected results in each experiment. Under the conditions of both experiments, the test substance did not induce mutations in the bacterial mutation assay in the absence and presence of metabolic activation in the selected strains of S. typhimurium (TA 98, TA 100, TA 1535 and TA 1537) and E.coli WP2 uvrA.
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.