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EC number: 203-920-2 | CAS number: 111-91-1
- 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:
- 06 December 2005 - 27 january 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is performed according to internationally accepted guidelines and under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(2-chloroethoxy)methane
- EC Number:
- 203-920-2
- EC Name:
- Bis(2-chloroethoxy)methane
- Cas Number:
- 111-91-1
- Molecular formula:
- C5H10Cl2O2
- IUPAC Name:
- 1-chloro-2-[(2-chloroethoxy)methoxy]ethane
- Details on test material:
- Name: Diformal
Appearance: clear colorless liquidt
chemical name: Bis-(2-chlorethyl)-formal
CAS: 111-91-1
EINECS: 2039202
Purity: 88.7%
Homogenicity: homogenous
Stability: see expiry data
Date of receipt: 29. Nov. 2005
Expiry date: 28. Mai. 2006
Storage: room temperature
Constituent 1
Method
- Target gene:
- histidine operon
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium LT2: strains TA1535, TA97a, TA98, TA100 and TA102
- Additional strain / cell type characteristics:
- other: TA97a: hisD6610, TA98: hisD3052 TA100 and TA1535 hisG46, TA102: hisG428, TA97a, TA98 und TA100 uvrB; TA97a, TA98, TA100 and TA102 Plasmid pKM 101 and are lipopolysaccharidesidechain deficient (rfa)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- First experiment: 5019, 1506, 502, 151 or 50 µg/plate
Second experiment: 4987, 2494, 1247 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test substance is completely soluble in DMSO and it is known that DMSO does not have any effects on the tester strains.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: - S9-mix: NPD 80 µg/Plate: TA97a, 98 und 102. Na-azid 6 µg/Plate: TA100 and 1535. +S9-mix: BaP 40 µg/Plate: TA98. 2-AA 3 µg/Plate, TA97a, 100, 102 and 1535.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: First experiment: in agar (plate incorporation). Second experiment: preincubation.
DURATION
- Preincubation period: second experiment: 20 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not applicable
SELECTION AGENT (mutation assays): histidine
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: 4 plates per strains per dose
NUMBER OF CELLS EVALUATED: all colonies were counted manually
DETERMINATION OF CYTOTOXICITY
- Method: the background lawn and number of spontanous reventant colonies was evaluated.
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: - Evaluation criteria:
- A positive response is defined as a twofold increase of the number of revertant colonies as compared to the negative control.
- Statistics:
- None
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium LT2: strains TA1535, TA97a, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- on the second experiment slight toxicity was observed in the highest concentration tested (5000 µg/plate) in strains TA97a and TA98. Further toxicity was not observed.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: not observed
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: no data
COMPARISON WITH HISTORICAL CONTROL DATA: the values for the solvent and positive controls are with the hitorical control values of the laboratory
ADDITIONAL INFORMATION ON CYTOTOXICITY: no data - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
First experiment:
strain |
|
TA97a |
|
TA98 |
|
TA100 |
|
TA102 |
|
TA1535 |
|
Metabolic activation |
|
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
Water |
Average |
115 |
119
|
7 |
9 |
148 |
120 |
150 |
168 |
6 |
9 |
|
SD |
18.3 |
23.2 |
2.9 |
3.6 |
21 |
40 |
48.5 |
37.9 |
1.9 |
3.0 |
DMSO |
Average |
131 |
136 |
7 |
12 |
143 |
156 |
150 |
186 |
11 |
15 |
|
SD |
31.0 |
11.3 |
2.2 |
2.0 |
26 |
35 |
48.0 |
11.3 |
3.9 |
5.1 |
Positive control |
Average |
791 |
673 |
3.81 |
831 |
664 |
713 |
446 |
1101 |
1001 |
79 |
|
SD |
244 |
302 |
105 |
341 |
201 |
294 |
19 |
200 |
0 |
18 |
|
F(I) |
6.04 |
4.95 |
54.4 |
69.3 |
4.49 |
4.57 |
2.97 |
5.92 |
167 |
5.27 |
5019 µg/plate |
Average |
120 |
114 |
13 |
5 |
117 |
141 |
133 |
97 |
22 |
32 |
|
SD |
33 |
34 |
2 |
3 |
43 |
7 |
44 |
16 |
7 |
6 |
|
F(I) |
0.92 |
0.84 |
1.86 |
0.42 |
0.82 |
0.90 |
0.89 |
0.52 |
2.00 |
2.13 |
1506 µg/plate |
Average |
106 |
95 |
8 |
7 |
89 |
104 |
88 |
113 |
13 |
16 |
|
SD |
31 |
27 |
8 |
2 |
14 |
9 |
38 |
10 |
4 |
4 |
|
F(I) |
0.81 |
0.70 |
1.14 |
0.58 |
0.62 |
0.67 |
0.59 |
0.61 |
1.18 |
1.07 |
502 µg/plate |
Average |
87 |
149 |
10 |
7 |
69 |
134 |
152 |
104 |
9 |
10 |
|
SD |
7 |
25 |
3 |
4 |
5 |
32 |
8 |
19 |
5 |
3 |
|
F(I) |
0.66 |
1.10 |
1.43 |
0.58 |
0.48 |
0.86 |
1.01 |
0.56 |
0.82 |
0.67 |
151 µg/plate |
Average |
129 |
133 |
12 |
5 |
79 |
167 |
123 |
114 |
7 |
9 |
|
SD |
30 |
42 |
2 |
3 |
44 |
23 |
40 |
33 |
3 |
3 |
|
F(I) |
0.98 |
0.98 |
1.71 |
0.42 |
0.55 |
1.07 |
0.82 |
0.61 |
0.64 |
0.60 |
50 µg/plate |
Average |
122 |
92 |
8 |
13 |
168 |
123 |
106 |
83 |
13 |
9 |
|
SD |
13 |
30 |
3 |
6 |
8 |
37 |
6 |
6 |
3 |
3 |
|
F(I) |
0.93 |
0.68 |
1.14 |
1.08 |
1.17 |
0.79 |
0.71 |
0.45 |
1.18 |
0.60 |
SD = standard deviation
F(I) = induction factor
Second experiment:
strain |
|
TA97a |
|
TA98 |
|
TA100 |
|
TA102 |
|
TA1535 |
|
Metabolic activation |
|
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
Water |
Average |
67 |
138 |
10 |
9 |
141 |
137 |
188 |
180 |
10 |
10 |
|
SD |
37.8 |
36.4 |
5.0 |
1.8 |
10 |
7 |
12.7 |
23.0 |
4.1 |
3.1 |
DMSO |
Average |
177 |
116 |
14 |
8 |
134 |
140 |
116 |
144 |
12 |
11 |
|
SD |
69.6 |
96.3 |
5.7 |
2.2 |
14 |
30 |
9.7 |
4.8 |
2.4 |
0.0 |
Positive control |
Average |
1001 |
359 |
995 |
39 |
729 |
504 |
1019 |
631 |
1001 |
106 |
|
SD |
0 |
124 |
13 |
49 |
184 |
111 |
36 |
74 |
0 |
59 |
|
F(I) |
5.66 |
3.09 |
71.1 |
4.88 |
5.17 |
3.60 |
8.78 |
4.38 |
100. |
9.64 |
4987 µg/plate |
Average |
35 |
38 |
6 |
2 |
74 |
123 |
44 |
74 |
13 |
16 |
|
SD |
40 |
31 |
3 |
1 |
16 |
53 |
11 |
23 |
6 |
7 |
|
F(I) |
0.20 |
0.33 |
0.43 |
0.25 |
0.55 |
0.88 |
0.38 |
0.51 |
1.08 |
1.45 |
2494 µg/plate |
Average |
118 |
96 |
8 |
6 |
131 |
142 |
156 |
167 |
18 |
15 |
|
SD |
62 |
34 |
2 |
2 |
11 |
14 |
7 |
29 |
2 |
2 |
|
F(I) |
0.67 |
0.83 |
0.57 |
0.75 |
0.98 |
1.01 |
1.34 |
1.16 |
1.50 |
1.36 |
1247 µg/plate |
Average |
227 |
162 |
10 |
6 |
122 |
130 |
159 |
158 |
14 |
18 |
|
SD |
31 |
39 |
4 |
2 |
15 |
18 |
19 |
26 |
4 |
7 |
|
F(I) |
1.28 |
1.40 |
0.71 |
0.75 |
0.91 |
0.93 |
1.37 |
1.10 |
1.17 |
1.64 |
SD = standard deviation
F(I) = induction factor
Comparison with historical control
strain |
|
TA97a |
|
TA98 |
|
TA100 |
|
TA102 |
|
TA1535 |
|
Metabolic activation |
|
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
Water |
Range |
72-153 |
57-162 |
6-16 |
6-26 |
93-179 |
92-178 |
91-187 |
95-239 |
6-19 |
5-25 |
|
Exp 1 |
115 |
119
|
7 |
9 |
148 |
120 |
150 |
168 |
6 |
9 |
|
Exp 2 |
67 |
138 |
10 |
9 |
141 |
137 |
188 |
180 |
10 |
10 |
DMSO |
Range |
22-176 |
58-174 |
4-19 |
3-24 |
90-162 |
73-172 |
79-199 |
70-237 |
5-19 |
6-17 |
|
Exp 1 |
131 |
136 |
7 |
12 |
143 |
156 |
150 |
186 |
11 |
15 |
|
Exp 2 |
177 |
116 |
14 |
8 |
134 |
140 |
116 |
144 |
12 |
11 |
Pos. Control |
Range |
304-1017 |
254-1001 |
223-1001 |
31-305 |
389-1170 |
160-1001 |
414-1144 |
118-1001 |
139-1001 |
63-359 |
|
Exp 1 |
791 |
673 |
3.81 |
831 |
664 |
713 |
446 |
1101 |
1001 |
79 |
|
Exp 2 |
1001 |
359 |
995 |
39 |
729 |
504 |
1019 |
631 |
1001 |
106 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
A significant or dose-related increase in the number of revertant colonies was not observed in any of the tested strains with or without metabolic activation. It is concluded that under the conditions of this test the test substance is not mutagenic in the Ames test. - Executive summary:
An ames test was performed accroding to OECD 471 and EC B.13/14 and under GLP. Two independent experiments were performed. The vehicle that was used is DMSO. The strains used were TA97a, TA98, TA100, TA102 and TA1535. The strains were exposed for 48 hours.
In the first experiment 5 concentrations were tested ranging from 50 -5000 µg/plate with and without metabolic activation. No toxicity to the test strains was observed. At the highest concentration a weak increase of revertant colonies was observed for TA1535. Since this was the only effect observed it was not seen as a sign of mutagneicity.
In the second experiment 3 concentartions were tested between 5000 -1250 µg/plate. No signs of mutagenicity were observed and slight toxicity was observed in strain TA97a and TA98 at the highest concentration tested.
In both studies the number of spontaneous revertants in the control group was within the historical control range and controls for confirmation of the genotype of the tester strains and the sterility check were in order. The number of revertant colonies in the positive controls showed a significant mutagenic response with and without S9 -mix.
Under the conditions of this test the test substance is not mutagenic.
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