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EC number: 202-888-7 | CAS number: 100-79-8
- 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:
- From 13 May 2009 to 28 October 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 471 with some deviations: only one experiment by direct incorporation method with negative results not confirmed and absence of confirmation not justified.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (only one experiment by direct incorporation method with negative results not confirmed and absence of confirmation not justified)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 19 November 2008
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2-dimethyl-1,3-dioxolan-4-ylmethanol
- EC Number:
- 202-888-7
- EC Name:
- 2,2-dimethyl-1,3-dioxolan-4-ylmethanol
- Cas Number:
- 100-79-8
- Molecular formula:
- C6H12O3
- IUPAC Name:
- (2,2-dimethyl-1,3-dioxolan-4-yl)methanol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): PEX-01; 2,2-Dimetil-4-Hidroximetil-1,3-
Dioxolano
- Physical state: Clear liquid
- Analytical purity: 99.5%
- pH of test substance = 6
- Composition of test material, percentage of components: 99.9% 2,2-Dimethyl-1,3-dioxolane-4-methanol; water: 0.02%; Acidity (Acetic acid): 0.0021%
- Lot/batch No.: 081001
- Expiration date of the lot/batch: 01 October 2009
- Stability under test conditions: Stable at room temperature and under normal conditions of use
- Storage condition of test material: at room temperature
Method
- Target gene:
- His+ for S. typhimurium
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: see table 7.6.1/1
- Metabolic activation:
- with and without
- Metabolic activation system:
- 5 % S9 mix; S9 fraction prepared from liver homogenates of Sprague-Dawley male rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- PRELIMINARY CYTOTOXICITY ASSAY
- Without S9 mix: 8, 40, 200, 1000 and 5000 μg/plate in TA 100 using plate-incorporation method.
MUTAGENICITY ASSAYS
- Experiment without S9 mix (plate-incorporation method): 650, 1080, 1800, 3000 and 5000 μg/plate (TA 1535, TA 1537, TA 98, TA 100 and TA 102)
- Experiment with S9 mix (plate-incorporation method): 650, 1080, 1800, 3000 and 5000 μg/plate (TA 1535, TA 1537, TA 98, TA 100 and TA 102) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide (5.0 µg/plate for TA 100 and TA 1535); ICR 191-Acridine (1.0 µg/plate for TA 1537); 2-Nitrofluorene (2.0 µg/plate for TA 98), Mitomycin C (0.5 µg/plate for TA 102)
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2.5 µg/plate for TA98, TA100, TA102, TA1535 and TA1537)
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- SOURCE OF TEST SYSTEM: All five strains were obtained from Moltox Inc. (Annapolis, MD, USA).
METHOD OF APPLICATION: Plate incorporation method
DURATION:
- Incubation period for plates: 72 h at 37 °C
NUMBER OF REPLICATIONS:
- Preliminary cytotoxicity assay: no data
- Mutagenicity assays: 3 plates/dose for each test concentration of test substance and negative
vehicle. 2 plates/dose for positive controls
NUMBER OF CELLS EVALUATED: no data
DETERMINATION OF CYTOTOXICITY:
- Method: Cytotoxicity is characterized by inhibition of the background bacterial lawn and inhibition or reduction in the number of colonies..
OTHERS:
- Sterility of top agar, S9 mix, solvent (DMSO), stock solution of test substance and minimal glucose agar plates were tested.
- Solubility: The solubility of the test substance was determined by dissolving the maximum recommended concentration in DMSO. Insolubility can be demonstrated as precipitation in the solution of test substance that is evident to the unaided eye.
- Cell viability test: Fresh cultures for the test were prepared by inoculating bacterial cultures into Erlenmeyer flasks containing 30 mL of Oxoid nutrient broth No 2. The bacterial cultures were incubated in a gyratory incubator for 16 to 18 hours at 37 ± 1ºC to obtain a density of approximately 108 - 109 cells per mL. The number of viable bacteria was determined by plating 100 μL of the culture dilution 10-6 onto nutrient agar plates. After incubation for 24 ± 2 hours at 37 ± 1ºC the number of colonies was recorded. - Evaluation criteria:
- - Results were presented as number of revertant colonies per plate and concentration and by the mutation rate, which corresponds to the rate among number of revertants induced by test substance and number of revertants observed in the negative vehicle control. A test substance is considered to be active in the test system if the mutation rates after 72 hours of incubation of strains exposed to the test substance are ≥ 2 for strains TA98, TA100 and TA102 or ≥ 3 for strains TA1535 and TA1537.
- To confirm the positive result the analysis of variance of the data set should indicate significant results (pANOVA<0.05) and a clear dose-related increase in the number of revertants should be observed. The analysis of variance indicates statistically significant differences among the average number of revertants in different concentrations. The dose-response effect is evaluated by means of simple linear regression, where the model Revertants (dose) = intercept + slope.dose is adjusted by leastsquares method. The regression indicates the probability of the number of revertants observed in the different concentrations be increased (mutagenicity) or decreased (toxicity).
The acceptance criteria of the assay are:
- presence of background lawn in the test plates;
- spontaneous revertant colony numbers of the negative control are in the range reported in the literature (Maron & Ames, 1983) and consistent to the historical control values;
- historical control data of the spontaneous, solvent and positive controls of the period from September 2007 to June 2009 were used to compare the revertant frequencies.
- positive controls show mutagenic activity in all tested strains. - Statistics:
- To confirm the positive result the analysis of variance of the data set should indicate significant results (pANOVA<0.05) and a clear dose-related increase in the number of revertants should be observed. The dose-response effect is evaluated by means of simple linear regression, where the model Revertants (dose) = intercept + slope.dose is adjusted by leastsquares method.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
Solubility: No data reported.
COMPARISON WITH HISTORICAL CONTROL DATA:
Compliance with historical control range data..
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Preliminary cytotoxicity assay:
No background bacterial lawn inhibition was observed at the tested concentrations (i.e. at 8, 40, 200, 1000 and 5000 μg/plate) in the absence of metabolic activation in the TA 100 strain.
Mutagenicity assays:
- No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment at any concentration level, neither in the presence nor absence of metabolic activation.
- No tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological significance.
- Mutation rates after 72 hours of incubation were lower than 2 and the analysis of variance of the data set indicated no significant difference (pANOVA>0.05) among the number of revertants, except for strains TA100 without metabolic activation and TA1535 with metabolic activation. In the assay with the strain TA100 (-S9) oscillations were observed among the numbers of revertants at the different tested concentrations. In the assays with TA1535 (+S9) there was a dose-response increase of the number of revertants. Mutation rates with increasing concentrations were below the border of biological significance as no doubling of the revertants was observed.
- No cytotoxicity was observed in any of the strains although it has been tested up to limit concentrations (5000 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 7.6.1/2: Mean revertant frequencies
Strains |
Doses (µg/plate) |
Mean revertants per plate |
|||
Mutagenicity assay |
|||||
-S9 |
+S9 |
||||
Mean |
MR |
Mean |
MR |
||
TA 1535 |
Solvent control |
46 |
- |
35 |
- |
650 |
47 |
1.02 |
47 |
1.37 |
|
1080 |
44 |
0.96 |
47 |
1.36 |
|
1800 |
47 |
1.03 |
43 |
1.24 |
|
3000 |
49 |
1.08 |
45 |
1.29 |
|
5000 |
46 |
1.01 |
48 |
1.38 |
|
PC |
2107 |
46.14 |
264 |
7.62 |
|
TA 1537 |
Solvent control |
9 |
- |
16 |
- |
650 |
11 |
1.21 |
20 |
1.20 |
|
1080 |
8 |
0.86 |
21 |
1.29 |
|
1800 |
7 |
0.79 |
20 |
1.22 |
|
3000 |
12 |
1.25 |
18 |
1.08 |
|
5000 |
7 |
0.71 |
17 |
1.06 |
|
PC |
1876 |
201.00 |
196 |
12.00 |
|
TA 98 |
Solvent control |
36 |
- |
41 |
- |
650 |
29 |
0.80 |
45 |
1.10 |
|
1080 |
39 |
1.08 |
37 |
0.90 |
|
1800 |
30 |
0.84 |
36 |
0.89 |
|
3000 |
35 |
0.97 |
35 |
0.85 |
|
5000 |
38 |
1.06 |
45 |
1.10 |
|
PC |
728 |
20.22 |
2107 |
51.39 |
|
TA 100 |
Solvent control |
193 |
- |
197 |
- |
650 |
181 |
0.94 |
195 |
0.99 |
|
1080 |
183 |
0.94 |
189 |
0.96 |
|
1800 |
199 |
1.03 |
191 |
0.97 |
|
3000 |
196 |
1.01 |
201 |
1.02 |
|
5000 |
185 |
0.96 |
192 |
0.97 |
|
PC |
2359 |
12.20 |
2338 |
11.85 |
|
TA 102 |
Solvent control |
313 |
- |
315 |
- |
650 |
311 |
0.99 |
305 |
0.97 |
|
1080 |
317 |
1.01 |
309 |
0.98 |
|
1800 |
303 |
0.97 |
308 |
0.98 |
|
3000 |
303 |
0.97 |
315 |
1.00 |
|
5000 |
309 |
0.99 |
307 |
0.97 |
|
PC |
1421 |
4.54 |
917 |
2.91 |
MR: Mutation rate = number of mutants in the treated / number of mutants in the control
PC: positive controls
Applicant's summary and conclusion
- Conclusions:
- Under these test conditions, PEX-01 was found to be not mutagenic in S. typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 with and without metabolic activation.
- Executive summary:
In a reverse gene mutation assay in bacteria, performed according to the OECD Guideline 471 and in compliance with GLP, strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98, TA 100 and TA 102) were exposed to 2,2-Dimethyl-1,3-dioxolane-4-methanol diluted in DMSO at the following concentrations for mutagenicity assay: 650, 1080, 1800, 3000 and 5000 μg/plate in the presence or in the absence of metabolic activation. Metabolic activation system used in this study was 5 % S9 mix. S9 fraction was prepared from liver homogenates of Sprague-Dawley male rats induced with Aroclor 1254. Vehicle and positive control groups were also included in this test.
No substantial increase in revertant colony numbers of any of the five tested strains was observed following treatment at any concentration level, neither in the presence nor absence of metabolic activation. No tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological significance. The positive and vehicle controls induced the appropriate responses in the corresponding strains. No cytotoxicity was observed in any of the strains although it has been tested up to limit concentrations required by the OECD Guideline 471 (5000 µg/plate).
Under these test conditions, 2,2-Dimethyl-1,3-dioxolane-4-methanol was found to be not mutagenic in S. typhimurium TA98, TA100, TA102, TA1535 and TA1537 with and without metabolic activation.
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