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EC number: 228-726-5 | CAS number: 6337-43-5
- 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:
- 13. Mar - 27. Mar 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP conform guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- other: Commission Directive 2000/32/EC, L1362000, Annex 4d, dated May 19, 2000
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guidelines: Kanpoan No 287-Environment Protection Agency; Eisei No. 127-Ministry of Health&Welfare, Heisei 09/10/21 Kikyoku No. 2-Ministry of International Trade&Industry
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate
- EC Number:
- 228-726-5
- EC Name:
- Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate
- Cas Number:
- 6337-43-5
- Molecular formula:
- C22H26O8
- IUPAC Name:
- 1,3-diethyl 2-({4-[3-ethoxy-2-(ethoxycarbonyl)-3-oxoprop-1-en-1-yl]phenyl}methylidene)propanedioate
- Test material form:
- other: solid
Constituent 1
Method
- Target gene:
- His
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: iin agar (plate incorporation); preincubation
DURATION
- Preincubation period: 100 µL test solution, 500 µL S9 mix/S9 mix substitution buffer and 100 µL bacterial suspension were mixed in a test tube and shaken at 37°C for 60 min.
- Exposure duration: 48 h at 37°C
SELECTION AGENT (mutation assays): His deficient medium
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: background growth - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An icrease exceeding the threshold at only one concentration is judged as biologically relevant if reporduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- No statistical evaluation of the data is required.
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:
- cytotoxicity
- Remarks:
- minor toxic effects
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
During the described mutagenicity test and under the experimental conditions reported the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
The assay was performed in two independent experiments both with and without liver microsomal activation using Salmonella thyphimurium strains TA 1535, TA 1537, TA 98 and TA 100 and the Escherichia coli strain WP2 uvrA.
The test item was tested at the following concentrations:
33, 100, 333, 1000, 2500 and 5000 µg/plate
The plates incubated with the test item showed normal background up to 5000 µg/plate with and without S9 mix in both experiments.
Minor toxic effects (below the factor 0.5), evident as reduction in the number of revertants, were observed in strain TA 1535 at 333 and 1000 µg/plate without metabolic activation and at 5000 µg/plate with and without metabolic activation in experiment I. In experiment II, a minor toxic effect was observed at 5000 µg/plate without metabolic activation in strain TA 98.
No substantial increase in revertant colony number of any of the five tester strains was observed following the treatment with the test item at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
In experiment I, with metabolic activation, the number of colonies did not quite reach the lower limit of the historical control data in strains TA 1535 (negative control) and TA 1537 (negative and solvent control). Sinced these deviationts are rather small, these effects are judged to be based upon statistical fluctuations and have no detrimantal impact on the outcome of the study. The historical range of positive controls was exceeded in strain TA 1535 (Exp. II) without metabolic activation. This effect indicates the sensitivity of the strains rather than compromising the assay.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies.
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