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EC number: 203-870-1 | CAS number: 111-44-4
- 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 23-sept-2015 to 18-apr-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(2-chloroethyl) ether
- EC Number:
- 203-870-1
- EC Name:
- Bis(2-chloroethyl) ether
- Cas Number:
- 111-44-4
- Molecular formula:
- C4H8Cl2O
- IUPAC Name:
- 1-chloro-2-(2-chloroethoxy)ethane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL
- Name (as cited): 2,2`- Dichlorodiethyl ether
- Purity: 99.76%
SOURCE OF TEST MATERIAL
- Batch No.: 20150706
- Expiration date of the lot/batch: 01 June 2016
- Purity test date: 28 August 2015
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled Room Temperature (15-25°C, below 70 RH%), protected from light
Method
- Target gene:
- hisD3052; hisG46; hisC3076; trpE
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix was made from the livers of male Sprague Dawley rats, which were treated with phenobarbital (PB) and β-naphthoflavone (BNF) at 80 mg/kg/day by oral gavage for three consecutive days. The S9 mix comprised 10% S9 fraction.
- Test concentrations with justification for top dose:
- 78.1; 156.2; 312.5; 625; 1250; 2500; 5000 µg/plate. No inhibitory, cytotoxic effect of the test item was observed in the preliminary experiment.
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: The test item was insoluble at 100 mg/mL concentration in Distilled water (stock solution); but the formulation at the same concentration using DMSO as vehicle (solvent) was a clear solution.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- Without activation: 4-nitro-1,2-phenylene-diamine (TA98 only) / Na-azide (TA100, TA 1535) / 9-aminoacridine (TA1537) / Methyl-methanesulfonate (WP2 uvrA) With activation: 2-aminoanthracene (all Solmonella strains and E. coli WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Cell density at seeding: 1.89-4.63E+09 CFU/mL
DURATION
- Preincubation period: 20 min
- Exposure duration: 48h - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA 1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas for TA 1537, at least a threefold increase should be reached. For TA 102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative. However, these guidelines may be overruled by good scientific judgment.
In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible. - Statistics:
- No statistics perfomed; evaluation based on criteria mentioned above
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- but relatively low number of revertants
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Dose-dependent increase in the observed mutation factor values at 5000 and 2500 μg/plate (mutation factor values of 2.78 and 2.12, respectively; threshold value: 2)
Any other information on results incl. tables
In the Initial Mutation Test (using the plate incorporation method), slight positive effect was observed in E. coli WP2 uvrA strain with metabolic activation. The observed mutation factor value (MF=2.12) at the highest examined concentration of 5000 μg/plate was above the threshold limit of 2 of this strain, and dose dependence was also observed. In the Confirmatory Mutation Test, a clear positive effect was seen: the observed mutation factor values at the two highest examined concentrations of 5000 and 2500 μg/plate were above the threshold limit of 2 of this strain (mutation factor values of 2.78 and 2.12, respectively) and dose dependence was also observed. Additionally, dose-dependent increase in the number of revertant colonies was also observed in this strain with metabolic activation using the pre-incubation method, although the mutation factor values remained slightly below the relevant threshold limit (MF=2) in that case (highest mutation factor value was 1.83).
In the Confirmatory Mutation Test using the pre-incubation method, biologically relevant increases were also observed in S. typhimurium TA1535 strain with metabolic activation. The observed mutation factor values were 4.91 and 3.18 at 2500 and 1250 μg/plate concentration, respectively (i.e. above the threshold limit of 3 of this strain). The observed values in the examined concentration range were compatible with a dose response curve (slightly lower value was detected at 5000 μg/plate due to the observed cytotoxicity on the plates). These values also indicate a mutagenic effect, although the numbers of revertant colonies seen in the DMSO control plates of this strain were relatively low compared to the untreated control (as indicated by the MF: 1.50 value of the untreated control). However, even compared with the untreated control, the mutation factor at 2500 μg/plate had a positive result with a mutation factor of 3.27.
Higher numbers of revertant colonies compared to the vehicle (solvent) control were detected in the main test in some other sporadic cases. However, no dose-dependence was observed in those cases and they were below the biologically relevant threshold value. The numbers of revertant colonies were within the historical control range in each case, so they were considered as reflecting the biological variability of the test. Sporadically, lower revertant counts compared to the vehicle (solvent) control were observed in the main test at some non-cytotoxic concentrations. However, no background inhibition was recorded and the mean numbers of revertant colonies were in the historical control range in all cases, thus they were considered as biological variability of the test system.
No inhibitory, cytotoxic effect of the test item was observed in the Initial Mutation Test using the plate incorporation method in any of the examined strains. However, inhibitory, cytotoxic effect of the test item (reduced / slightly reduced background lawn development, pinpoint colonies were also detected in some cases) was observed in the Confirmatory Mutation Test using the pre-incubation method in all examined strains at 5000 μg/plate concentration with and without metabolic activation and in Salmonella typhimurium TA1537 strain at 2500 μg/plate without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this test, the test item 2,2’-Dichlorodiethyl ether exhibit a weak mutagenic activity in S. typhimurium TA 1535 and E. coli WP2 uvrA with metabolic activation.
- Executive summary:
The test substance was evaluated in an Ames Test on Salmonella typhimurium strains TA 1535, TA 100, TA, 1537, TA 98, and Escherischia coli WP2 uvrA, performed according to OECD TG 471. In the Initial Mutation Test a weak positive effect of the test item was obtained in Escherichia coli WP2 uvrA strain with metabolic activation using the plate incorporation method (the observed revertant colony numbers were above the respective biological threshold value, slight dose response was also indicated). Although the effect was weak, it was reproducible in the Confirmatory Mutation Test using the same test conditions. Furthermore, a weak positive effect of the test item was also observed in the Confirmatory Mutation Test in Salmonella typhimurium TA1535 strain with metabolic activation using the pre-incubation method.
The reported data of this mutagenicity assay show that under the experimental conditions applied the test item induced gene mutations by base pair changes or frameshifts in the genome of the strains Escherichia coli WP2 uvrA and Salmonella typhimurium TA1535 strains in the presence of metabolic activation. In conclusion, the test item 2,2’-Dichlorodiethyl ether exhibit a weak mutagenic activity under the test conditions of this study.
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