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EC number: 434-800-1 | CAS number: 121776-33-8
- 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 June 24, 1988 to Sep 26, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- Deviations:
- yes
- Remarks:
- No stability and analytical concentration of the test subsatnce was determined. However, these deviations should not significantly impact study results.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 434-800-1
- EC Name:
- -
- Cas Number:
- 121776-33-8
- Molecular formula:
- C11H13CL2NO3
- IUPAC Name:
- 2,2-dichloro-1-[5-(furan-2-yl)-2,2-dimethyl-1,3-oxazolidin-3-yl]ethan-1-one
- Reference substance name:
- 3-(Dichloroacetyl)-5-(2-furanyl)-2,2-dimethyloxazolidine
- IUPAC Name:
- 3-(Dichloroacetyl)-5-(2-furanyl)-2,2-dimethyloxazolidine
- Test material form:
- other: Brown particles
- Details on test material:
- - Name of test material (as cited in study report): MON 13900
- Physical state: Brown particles
- Analytical purity: 99.1%
- Lot/batch No.: Lot NBP 3747116 B
- Expiration date of the lot/batch: Expiration 5/92
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 0.1, 0.3, 1, 3 and 10 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without metabolic activation for TA 98
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- With metabolic activation for TA 98
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without metabolic activation for TA 100
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With metabolic activation for TA 100
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: Sodium nitrite
- Remarks:
- Without metabolic activation for TA 1535
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With metabolic activation for TA 1535
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without metabolic activation for TA 1537
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- With metabolic activation for TA 1537
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
DURATION
- Exposure duration: 48 h at 37±10⁰C
NUMBER OF REPLICATIONS: Three
DETERMINATION OF CYTOTOXICITY
Revertant colonies for plates with more than 500 revertant colonies/plate were estimated by counting revertant colonies in several fields under a stereomicroscope and multiplying the counted colonies by a factor relating the total plate area to the area of the counted fields. Revertant colonies measured in this manner are calculated to not more than three significant figures. Revertant colonies on other plates, except as noted, were counted with an Artek Model 880 automatic colony counter or counted by visual examination (<10 revertants/plate). - Evaluation criteria:
- Results were considered positive for a strain/microsome combination if revertants/plate values were significantly elevated over control values (p<0.01) at three treatments and there was a statistically significant dose response (p<0.01).
- Statistics:
- Statistical analysis was performed on plate incorporation assay results after transforming revertant/plate values as log10 (revertants/plate). Analysis included Bartlett’s test for homogeneity of variance and comparison of treatments with controls using within-levels pooled variance and a one-sided t-test. Grubbs’ test was performed to determine if outliers were present. Statistical significance of dose response was evaluated by regression analysis for log10 transformed doses and revertants/plate.
Results and discussion
Test results
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Results of the statistical analyses of the plate incorporation assay results indicated that the test substance was mutagenic towards test strain TA100 in the presence and absence of S-9 mix. In combination, statistical analyses of both the initial and repeat assays for TA100 in the presence and absence of S-9 mix, indicated three treatments with revertants/plate values significantly greater than controls (p<0.01) and significant positive dose responses (p<0.01). The mutagenic response was very weak compared to other agents which are positive in this assay (2 fold over control values) and the high dose levels (3 and 10 mg/plate) were required to elicit a detectable response. The revertants/mg values calculated from the slope of the dose response curves were similar, with a range of 9.6-12.8 in the presence of S-9 and 10.9-16.1 in the absence of S-9 Mix. No mutagenic activity was indicated in these assays towards any of the other test strains used (TA98, TA1535, and TA1537). None of these other strain/microsome combinations indicated three treatments with revertants/plate values greater than controls (p<0.01) or significant dose responses (p<0.01). The repeat assay of TA98 in the absence of S-9 mix indicated one treatment with revertants/plate values significantly greater than controls (P<0.01) but with no positive dose response (P<0.01). This result was not observed in the initial assay and was not reproducible in a retest run at a narrow dose range.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
A toxicity screen was conducted using test strain TA100 with and without S-9 Mix. The test substance was not toxic at levels up to 10 mg/plate in the presence or absence of S-9 Mix. The test substance was observed to be insoluble at a level of 10 mg/plate. The maximum treatment level used in plate incorporation tests was 10 mg/plate. Some toxicity was observed in plate incorporation assays at the 10 mg/plate level. In the initial assay, toxicity was observed for TA98 and TA100 in the absence of S-9. In the repeat assays toxicity was seen for test strains TA100 in the presence and absence of S-9 mix and for TA1535 in the presence of S-9 mix.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, MON 13900 produced a very weak mutagenic response towards S. typhimurium strain TA 100 independent of the presence of a metabolic activation system. The response of greater than two fold the control was only observed at a concentration (10 mg/plate) which was toxic and at which the test substance was insoluble. The results in all other tester strain were considered to be uniformly negative.
- Executive summary:
A study was conducted to determine the mutagenic potential of MON 13900 in an Ames mutagenicity assay according to EPA OPP 84-2 in compliance with GLP.
The test used S. typhimurium strains TA98, TA100, TA1535 and TA1537 in the presence and absence of S9 mix. In the screen, no toxicity was observed for TA100 in the presence or absence of S9 at levels up to 10 mg/plate. The test substance was observed to be insoluble at 10 mg/plate and some toxicity was observed in plate incorporation assays at this dose. Mutagenic activity was observed for the test substance towards test strain TA100 in the presence and absence of S9. The combination of statistical analyses of the initial and repeat test results indicated three treatments with revertants/plate values significantly greater than controls (p < 0.01) and significant positive dose-responses (p < 0.01). Based on these results, it appears that the activity is direct-acting and not dependent on the presence of an exogenous metabolic activation system. The observed response was very weak in terms of magnitude (2-fold above controls) and compared to other agents that are positive in this assay. The potency of the response as calculated by the slope of the dose response curves gave a range of 0.003 - 0.004 revertants/nmole in the presence and absence of S9 mix for both initial and repeat assays. The repeat assay of TA98 in the absence of S9 mix indicated one treatment level with revertants/plate values significantly greater than controls (p < 0.01), with no positive dose-response. This result was not observed in the initial assay and was not reproducible in a retest run at a narrow dose range.
Under the test conditions, MON 13900 elicited a very weak mutagenic response towards S. typhimurium strain TA 100 independent of the presence of a metabolic activation system. The response of greater than 2- fold the control was only observed at a concentration which was toxic (10 mg/plate) and at which the test substance was insoluble. No reproducible mutagenic activity was observed for any of the other strains (TA 98, TA 1535 and TA 1537) in the presence or absence of metabolic activation.
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