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EC number: 700-238-1 | CAS number: 132900-75-5
- 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:
- 2008-06-18 to 2008-08-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-methylbenzene-1,4-diyl bis{4-[4-(acryloyloxy)butoxy]benzoate}
- EC Number:
- 700-238-1
- Cas Number:
- 132900-75-5
- Molecular formula:
- C35H36O10
- IUPAC Name:
- 2-methylbenzene-1,4-diyl bis{4-[4-(acryloyloxy)butoxy]benzoate}
- Reference substance name:
- 4-({4-[4-(Acryloyloxy)butoxy]benzoyl}oxy)-2-methylphenyl 4-[4-(acryloyloxy)butoxy]benzoate
- IUPAC Name:
- 4-({4-[4-(Acryloyloxy)butoxy]benzoyl}oxy)-2-methylphenyl 4-[4-(acryloyloxy)butoxy]benzoate
- Details on test material:
- Name: Me-3K4A2
CAS no.: 132900-75-5
Chemical name: Benzoic acid, 4-[4-[(1-oxo-2-propenyl)oxy]butoxy]-, 2-methyl-1,4-phenylene ester
Puropse: industrial chemical
Colour: beige
Physical state: powder Storage: at room temperature, protected from light
Stability in solution: water: probably stable
Special procedures: prepare freshly
Constituent 1
Constituent 2
Method
- Target gene:
- not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- TA 98: his D 3052, rfa-; uvrB-; R-factor
TA 100: his G 46, rfa-; uvrB-; R-factor
TA 1535: his G 46, rfa-; uvrB-
TA 1537: his C 3076, rfa-; uvrB-
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- TA 102: his G 428 (pAQ1), rfa-; uvrB-; R-factor
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Pretest: 3.16, 10, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate with/without activation
Main experiment 1 and 2: 31.6, 100, 316, 1000, 2500 and 5000 µg/plate with/without activation - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- For TA 100, TA 1535 without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylene-diamine
- Remarks:
- For TA 98, TA 1537 without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- all strains with S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- For TA 102 without S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, 1st main experiment); preincubation (2nd main experiment)
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
- Evaluation criteria:
- The test is considered acceptable if the bacteria demonstrate their typical responses to ampicil-lin (TA 98, Ta 100, TA 102); the control plates with and without S9 are within the following ranges (mean values of the spontaneous reversion frequency are within the historical control data range: TA 98 18-54 (-S9), 18-71 (+S9); TA 100 75-167 (-S9), 81-168 (+S9); TA 102 165-391 (-S9), 163-594 (+S9); TA 1535 5-29 (-S9), 6-31 (+S9); TA 1537 5-30 (-S9), 6-36 (+S9)); corresponding background growth on negative control, solvent control and test plates is ob-served; the positive controls show a distinct enhancement of revertant rates over the control plate. A biologically relevant increase with or without metabolic activation is
- if in tester strains TA100 and TA 102 the number of reversions is at least twice as high
- if in the other tester strains the number of reversions is at least three times higher
than the reversion rate of the solvent control. - Statistics:
- not reported
Results and discussion
Test resultsopen allclose all
- 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:
- >= 2500 µg/plate, preincubation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- >= 2500 µg/plate, preincubaition
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate, plate incorporation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 5000 µg/plate, plate incorporation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Effects of osmolality: none
- Evaporation from medium: none
- Water solubility: none
- Precipitation: yes, 2nd experiment > = 1000 µg/plate (without S9), 5000 µg/plate (with S9)
RANGE-FINDING/SCREENING STUDIES: yes
COMPARISON WITH HISTORICAL CONTROL DATA: yes
ADDITIONAL INFORMATION ON CYTOTOXICITY: not reported - 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
The substance did not induce any mutagenic effect in the Ames test with and without metabolic activation under the conditions used. - Executive summary:
The test item Me3K4A2 was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The concentrations of 31.6, 100, 316, 1000, 2500 and 5000 µg/plate were prepared in DMSO as a vehicle and used. Precipitation of the test item was observed in all tester strains used in experiment II (with and without metabolic activation). In experiment I no precipitation of the test item was found in any of the five tester strains used (with and without activation), in experiment II precipitation of the test item was found at doses of 1000 µg/plate and higher (without metabolic activation) and at a dose of 5000 µg/plate (with metabolic activation).
Toxic effects of the test item were noted in some tester strains evaluated in experiments I and II. In experiment I toxic effects of the test item were observed only in tester strain TA 1537 at a dose of 5000 µg/plate with metabolic activation. In experiment II toxic effects of the test item were noted in tester strain TA 98 at doses of 2500 µg/plate and higher with and without metabolic activation. The reduction in the number of revertants down to a mutation factor of 0.5 found in tester strain TA 1537 at a dose of 31.6 µg/plate (without metabolic activation) was regarded as not biologically relevant due to lack of the dose-response relationship.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with Me3K4A2 at any concentration level, neither in the presence nor absence of metabolic activation in experiments I and II.
The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Me3K4A2 did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, Me3K4A2 is considered to be non-mutagenic in this bacterial reverse mutation assay according to OECD guideline 471.
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