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EC number: 903-945-5 | 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
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- Flash point
- Auto flammability
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- 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
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- Nanomaterial specific surface area
- Nanomaterial Zeta potential
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- Endpoint summary
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- Environmental data
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Carcinogenicity
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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:
- From 07 july 2003 to 10 oct 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, OECD 471 compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Chlorodifluoroacetic acid
- EC Number:
- 200-928-8
- EC Name:
- Chlorodifluoroacetic acid
- Cas Number:
- 76-04-0
- Molecular formula:
- C2HClF2O2
- IUPAC Name:
- chloro(difluoro)acetic acid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix rat liver fraction treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 0, 312.5, 625, 1250, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: NaCl (0.9%)
- Justification for choice of solvent/vehicle: the most appropriate for the solubility of CDFA, and among recommended vehicles by the guideline.
Controls
- Untreated negative controls:
- no
- Remarks:
- vehicle served as negative control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 9-Aminoacridine, 2-Nitroflurene, Mytomycin C, 4-Nitroquinoline-1oxide, 2-Anthramine
- Remarks:
- Details in test conditions
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) for preliminary toxicity test and for the first experiment and in the second experiment without S9 mix; preincubation in the second experiment with S9 mix.
DURATION
- Preincubation period: 60 minutes at 37°C
- Exposure duration: 48 to 72 hours at 37°C
NUMBER OF REPLICATES: 3 - Evaluation criteria:
- A reproductible 2-fold increase (for the TA 98, TA 100, TA 102, and E. coli WP2 uvrA strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- thinning of the bacterial lawn only in TA 100 strain
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING STUDY:
With a treatment volume of 100 µL/plate, the dose levels were 10, 100, 500, 1000, 2500 and 5000 µg/plate.
No precipitate was observed in the Petri plates when scoring the revertants at all dose-levels.
No noteworthy toxicity was noted towards the four satrins used, with and without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA: the number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
Any other information on results incl. tables
First experiment: Direct plate incorporation method
Strain |
Compound |
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
TA 1535 |
0.9% NaCl |
0 |
- S9 mix |
14 |
CDFA |
312.5 |
15 |
||
625 |
15 |
|||
1250 |
10 |
|||
2500 |
15 |
|||
5000 |
11 |
|||
NAN3 |
1 |
530 |
||
0.9% NaCl |
0 |
+ S9 mix |
14 |
|
CDFA |
312.5 |
13 |
||
625 |
13 |
|||
1250 |
14 |
|||
2500 |
14 |
|||
5000 |
13 |
|||
2AM |
2 |
251 |
||
TA 100 |
0.9% NaCl |
0 |
- S9 mix |
97 |
CDFA |
312.5 |
98 |
||
625 |
117 |
|||
1250 |
101 |
|||
2500 |
113 |
|||
5000 |
102 |
|||
NAN3 |
1 |
615 |
||
0.9% NaCl |
0 |
+ S9 mix |
119 |
|
CDFA |
312.5 |
129 |
||
625 |
119 |
|||
1250 |
110 |
|||
2500 |
114 |
|||
5000 |
101 |
|||
2AM |
2 |
1750 |
||
TA 102 |
0.9% NaCl |
0 |
- S9 mix |
393 |
CDFA |
312.5 |
367 |
||
625 |
426 |
|||
1250 |
375 |
|||
2500 |
400 |
|||
5000 |
368 |
|||
NAN3 |
1 |
1332 |
||
0.9% NaCl |
0 |
+ S9 mix |
582 |
|
CDFA |
312.5 |
561 |
||
625 |
571 |
|||
1250 |
519 |
|||
2500 |
588 |
|||
5000 |
472 |
|||
2AM |
2 |
1768 |
Strain |
Compound |
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
WP2 uvrA |
0.9% NaCl |
0 |
- S9 mix |
30 |
CDFA |
312.5 |
31 |
||
625 |
32 |
|||
1250 |
38 |
|||
2500 |
31 |
|||
5000 |
29 |
|||
NAN3 |
1 |
219 |
||
0.9% NaCl |
0 |
+ S9 mix |
37 |
|
CDFA |
312.5 |
38 |
||
625 |
33 |
|||
1250 |
25 |
|||
2500 |
32 |
|||
5000 |
32 |
|||
2AM |
2 |
480 |
||
TA 1537 |
0.9% NaCl |
0 |
- S9 mix |
5 |
CDFA |
312.5 |
6 |
||
625 |
7 |
|||
1250 |
9 |
|||
2500 |
5 |
|||
5000 |
4 |
|||
NAN3 |
1 |
280 |
||
0.9% NaCl |
0 |
+ S9 mix |
7 |
|
CDFA |
312.5 |
8 |
||
625 |
6 |
|||
1250 |
7 |
|||
2500 |
10 |
|||
5000 |
7 |
|||
2AM |
2 |
108 |
||
TA 98 |
0.9% NaCl |
0 |
- S9 mix |
21 |
CDFA |
312.5 |
20 |
||
625 |
21 |
|||
1250 |
21 |
|||
2500 |
22 |
|||
5000 |
30 |
|||
NAN3 |
1 |
211 |
||
0.9% NaCl |
0 |
+ S9 mix |
28 |
|
CDFA |
312.5 |
27 |
||
625 |
27 |
|||
1250 |
30 |
|||
2500 |
27 |
|||
5000 |
30 |
|||
2AM |
2 |
1699 |
Second experiment : Direct plate incorporation method (without S9 mix) and preincubation method (with S9 mix)
Strain |
Compound |
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
TA 1535 |
0.9% NaCl |
0 |
- S9 mix |
12 |
CDFA |
312.5 |
17 |
||
625 |
12 |
|||
1250 |
13 |
|||
2500 |
13 |
|||
5000 |
14 |
|||
NAN3 |
1 |
607 |
||
0.9% NaCl |
0 |
+ S9 mix |
12 |
|
CDFA |
312.5 |
15 |
||
625 |
18 |
|||
1250 |
13 |
|||
2500 |
13 |
|||
5000 |
11 |
|||
2AM |
2 |
147 |
||
TA 100 |
0.9% NaCl |
0 |
- S9 mix |
93 |
CDFA |
312.5 |
108 |
||
625 |
107 |
|||
1250 |
128 |
|||
2500 |
123 |
|||
5000 |
123 |
|||
NAN3 |
1 |
640 |
||
0.9% NaCl |
0 |
+ S9 mix |
119 |
|
CDFA |
312.5 |
132 |
||
625 |
131 |
|||
1250 |
135 |
|||
2500 |
128 |
|||
5000 |
138 |
|||
2AM |
2 |
1539 |
||
TA 102 |
0.9% NaCl |
0 |
- S9 mix |
399 |
CDFA |
312.5 |
394 |
||
625 |
420 |
|||
1250 |
427 |
|||
2500 |
401 |
|||
5000 |
437 |
|||
NAN3 |
1 |
1342 |
||
0.9% NaCl |
0 |
+ S9 mix |
483 |
|
CDFA |
312.5 |
460 |
||
625 |
452 |
|||
1250 |
453 |
|||
2500 |
490 |
|||
5000 |
438 |
|||
2AM |
2 |
2122 |
Strain |
Compound |
Dose level (µg/plate) |
Metabolic activation |
Mean revertant colony counts |
WP2 uvrA |
0.9% NaCl |
0 |
- S9 mix |
29 |
CDFA |
312.5 |
32 |
||
625 |
24 |
|||
1250 |
20 |
|||
2500 |
19 |
|||
5000 |
32 |
|||
NAN3 |
1 |
468 |
||
0.9% NaCl |
0 |
+ S9 mix |
42 |
|
CDFA |
312.5 |
39 |
||
625 |
39 |
|||
1250 |
47 |
|||
2500 |
30 |
|||
5000 |
38 |
|||
2AM |
2 |
221 |
||
TA 1537 |
0.9% NaCl |
0 |
- S9 mix |
6 |
CDFA |
312.5 |
14 |
||
625 |
6 |
|||
1250 |
6 |
|||
2500 |
14 |
|||
5000 |
6 |
|||
NAN3 |
1 |
285 |
||
0.9% NaCl |
0 |
+ S9 mix |
7 |
|
CDFA |
312.5 |
6 |
||
625 |
8 |
|||
1250 |
6 |
|||
2500 |
10 |
|||
5000 |
9 |
|||
2AM |
2 |
142 |
||
TA 98 |
0.9% NaCl |
0 |
- S9 mix |
26 |
CDFA |
312.5 |
29 |
||
625 |
30 |
|||
1250 |
32 |
|||
2500 |
24 |
|||
5000 |
26 |
|||
NAN3 |
1 |
172 |
||
0.9% NaCl |
0 |
+ S9 mix |
23 |
|
CDFA |
312.5 |
26 |
||
625 |
29 |
|||
1250 |
25 |
|||
2500 |
22 |
|||
5000 |
16 |
|||
2AM |
2 |
1675 |
Applicant's summary and conclusion
- Conclusions:
- Chlorodifluoroacetic acid did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli in the absence and presence of metabolic activation.
- Executive summary:
In a reverse gene mutation assay in bacteria, strains TA 98, TA 100, TA 102, TA 1535, TA 1537 of S. typhimurium and E. coli E. coli WP2 uvr A were exposed to Chlorodifluoroacetic acid at concentrations of 0 to 5000 µg/plate in the presence and absence of mammalian metabolic activation (rat liver).
The plate incorporation method was used for preliminary toxicity test and for the first experiment and in the second experiment without S9 mix. Pre-incubation was used in the second experiment with S9 mix.
The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of increase of mutant colonies. Chlorodifluoroacetic acid did not show mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium and Escherichia coli.
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