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EC number: 206-581-9 | CAS number: 355-37-3
- 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
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- 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:
- 1994-04-06 t 1994-06-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Standards for Toxicity Investigations (Japan's Ministry of Labor, No. 77, September 1, 1988) and Notification on Partial Revision of Testing Methods Relating to the New Chemical Susbtances (Notification No. 700 of the Planning and Coordination Bureau, EA, No. 1039 of the Pharmaceutical Affairs Bureau, MHW & No. 1014 (1986) of the Basic Industries Bureau, MITI, December 5, 1986).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane
- EC Number:
- 206-581-9
- EC Name:
- Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane
- Cas Number:
- 355-37-3
- Molecular formula:
- C6HF13
- IUPAC Name:
- 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Asahi Glass Co., Ltd.; Batch no. 31001
- Expiration date of the lot/batch: Not specified
- Purity test date: Not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored in a cold and dark place
- Stability under test conditions: Not specified
FORM AS APPLIED IN THE TEST (if different from that of starting material): Colourless clear liquid
OTHER SPECIFICS:
Purity: 99.9%
Impurities: CClF2HCCl2F (0.05%)
Molecular Weight: 320.05
Boiling Point 71°C
Solubility: Oil soluble
Degree of Solublity Water (<10 mg/L)
DMSO (<5% w/v)
Acetone (≥ 10% w/v)
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat Liver S9
- Test concentrations with justification for top dose:
- Dose range-finding test: 0, 50, 100, 200, 500, 1000, 2000, or 5000 µg/plate
Main Test: 0, 313, 625, 1250, 2500, or 5000 µg/plate (Based on the results of the dose range-finding test, 5000 µg/plate was selected as the highest dose and the lower four doses diluted with a geometric progression of 2 were set). - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: Not specified
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2); 2-Aminoanthracene (2AA); 2-Methoxy-6-chloro--9-[3-(2-chloroethyl)-aminopropylamino]acridine.2HCl
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): Main Test - TA98: 2.0 x 10^9 viable cells/mL; TA100: 1.6 x 10^9 viable cells/mL; TA1535: 2.1 x 10^9 viable cells/mL; TA1537: 1.8 x 10^9 viable cells/mL; WP2 uvrA: 1.9 x 10^9 viable cells/mL
DURATION
- Preincubation period: 37 ± 0.5°C for 8-10 hours
- Expression time (cells in growth medium): 20 minutes
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): Not specified
NUMBER OF REPLICATIONS: 3 (negative control); 2 (Test substance and positive controls)
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: The appearance of revertant colonies (size and number), deposition of the test substance and growth inhibition were examined with a stereo microscope.
NUMBER OF CELLS EVALUATED: The number of revertant colonies was counted with a manual counter or a colony analyzer (CA-7, Toyo-sokki Co., Ltd.). The count using the colony analyzer was finalized after correcting with count drop. Each plate was measured three times, and the average of these three individual measurements with rounding off the figures below decimal point was adopted as the number of revertant colonies. - Evaluation criteria:
- The test substance was judged to be positive, when the number of revertant colonies was increased more than twice that of the negative control in a dose-dependant manner, and the reproducibility of results was also obtained. It was judged to be negative in the other cases.
- Statistics:
- Statistical analysis was not applied.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not examined
- 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:
- not examined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The sterility test confirmed the absence of micro-organisms.
Any other information on results incl. tables
Table 1. Results of the Main Test |
||||||
With (+) or Without (-S9) Mix |
Test Substance Dose (µg/plate) |
Number of Revertants per Plate |
||||
Base-pair Substitution Type |
Frameshift Type |
|||||
TA 100 |
TA 1535 |
WP2uvrA |
TA 98 |
TA 1537 |
||
-S9 Mix |
Negative Control |
131 153 (134) 117 |
12 8 (10) 9 |
44 47 (43) 37 |
22 20 (19) 14 |
10 12 (10) 8 |
313 |
174 152 (163) |
17 13 (15) |
61 46 (54) |
26 34 (30) |
15 4 (10) |
|
625 |
119 113 (116) |
9 18 (14) |
52 53 (53) |
17 24 (21) |
22 5 (14) |
|
1250 |
162 158 (160) |
14 15 (15) |
51 43 (47) |
24 28 (26) |
5 11 (8) |
|
2500 |
147 147 (147) |
10 17 (14) |
48 42 (45) |
19 29 (24) |
11 12 (12) |
|
5000 |
147 147 (147) |
11 15 (13) |
41 43 (42) |
26 16 (21) |
8 7 (8) |
|
|
||||||
+S9 Mix |
Negative Control |
148 148 (148) 148 |
21 28 (22) 16 |
51 47 (49) 49 |
34 29 (34) 39 |
24 19 (17) 8 |
313 |
149 168 (159) |
13 18 (16) |
57 52 (55) |
41 37 (39) |
14 22 (18) |
|
625 |
133 143 (138) |
11 14 (13) |
50 61 (56) |
43 48 (46) |
22 13 (18) |
|
1250 |
147 134 (141) |
14 12 (13) |
53 52 (53) |
29 30 (30) |
11 25 (18) |
|
2500 |
112 147 (130) |
12 14 (13) |
55 41 (48) |
38 30 (34) |
17 19 (18) |
|
5000 |
158 138 (148) |
15 22 (19) |
54 56 (55) |
36 35 (36) |
15 20 (18) |
|
|
||||||
Positive Control (-S9 Mix) |
Chemical |
AF-2 |
NaN3 |
AF-2 |
AF-2 |
ICR-191 |
Dose (µg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
1 |
|
Number of Revertants /plate |
424 398 (411) |
295 297 (296) |
444 412 (428) |
395 445 (420) |
1925 1948 (1937) |
|
|
||||||
Positive Control (+S9 Mix) |
Chemical |
2AA |
2AA |
2AA |
2AA |
2AA |
Dose (µg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|
Number of Revertants /plate |
647 632 (640) |
151 130 (141) |
447 450 (449) |
140 149 (145) |
122 123 (123) |
1) values in parenthesis show the mean of each plate
2) AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)
3) 2AA: 2-Aminoanthracene
4) ICR-191: 2-Methoxy-6-chloro--9-[3-(2-chloroethyl)-aminopropylamino]acridine.2HCl
5) NaN3: Sodium Azide
Applicant's summary and conclusion
- Conclusions:
- 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane was considered to have no reverse mutagenic potential under the conditions of the study.
- Executive summary:
In a key bacterial reverse mutation assay, the in vitro mutagenic potential of the test material, 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane, was evaluated in Salmonella typhimurium strains TA98, TA100, T1535, and TA 1537 and Escherischia coli strain WP2uvrA using pre-incubation method in the absence and presence of a metabolic activation system (±S9).
Based on a dose range-finding study, the concentrations of the test material used in the main study were 0, 313, 625, 1250, 2500, or 5000 µg/plate.
It was observed that the number of revertant colonies in all strains was less than twice that of the negative control at all dose levels tested in the absence and presence of metabolic activation (±S9). The positive controls exhibited a significant increase in the number of revertant colonies and the number of revertants for positive as well as negative controls was within the historical range.
Based on the results observed in the study, 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane was considered to be negative in this bacterial reverse mutation assay.
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