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EC number: 435-360-1 | CAS number: 144447-11-0
- 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:
- 6 September 2001- 17 September 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 435-360-1
- EC Name:
- -
- Cas Number:
- 144447-11-0
- Molecular formula:
- C20H22O5
- IUPAC Name:
- 4-methoxyphenyl 4-[4-(oxiran-2-yl)butoxy]benzoate
- Details on test material:
- Identification: Epoxyhexmes
Trade Name: Epoxyhexmes
Chemical name: 4-methoxyphenyl-4(5,6-epoxyhexyloxy)benzoate
CAS-No: 144447-11-0
Description: White crystalline solid
Batch: RTC9811501003
Purity: 97.3%
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
Expiry date: 31 December 2001
Constituent 1
Method
- Target gene:
- Histidine/tryptophan operon
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: Detects base-pair substitutions. The strain lacks an excision repair system and is sensitive to agents such as UV.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: See below
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 0, 3, 10, 33, 100, 333, 666, 1000, 3330, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO;
- Justification for choice of solvent/vehicle: none
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulfoxide (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See below
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): histidine/tryptophan
NUMBER OF REPLICATIONS: triplicate plates per concentration
NUMBER OF CELLS EVALUATED: all colonies were counted
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth, background lawn - Evaluation criteria:
- - The negative control data (number of spontaneous revertants per plate) should be within the laboratory background historical range for each tester strain.
- The positive control chemicals should produce responses in all tester strains which are within the laboratory historical range documented for each positive control substance.
- The selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.
No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any of the tester strains, either with or without metabolic activation.
However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: precipitated > 666 µg/plate in the main study
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES:
In the range finding test the substance was tested in the tester strains TA100 and WP2uvrA with concentrations of 3, 10,33, 100,333, 1000,3330 and 5000 µg/plate in the absence and presence of S9-mix.
Based on the results of the dose range finding test, it was tested up to concentrations of 3330 µg/plate in the absence and presence of S9-mix in a mutation assay. The test substance was tested beyond the limit of the solubility to obtain adequate mutagenicity data. The mutation experiment was performed with the strains TA1535, TA1537 and TA98.
COMPARISON WITH HISTORICAL CONTROL DATA:
The negative and strain-specific positive control values were within the laboratory background historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly
ADDITIONAL INFORMATION ON CYTOTOXICITY: None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
The substance is mutagenic in the bacterial reverse mutation assay. - Executive summary:
The substance was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA100 and.TA98) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coliWP2uvrA.
The test was performed in the presence and absence of S9-mix (Aroclor-1254 induced rat liver S9-mix). In the dose range finding test, the substance was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The substance precipitated on the plates at dose levels of 1000 µg/plate and upwards. The bacterial background lawn was not reduced at all concentrations tested and no biologically relevant decrease in the number of revertants was observed. In the mutation assay, the substance was tested up to concentrations of 3330 µg/plate in the absence and presence of S9-mix. the substance precipitated on the plates at dose levels of 1000 and 3330 µg/plate. The bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.
In tester strain TA100, the substance induced up to 2.0- and 4.8-fold, dose related increases in the number of revertant colonies compared to the solvent control in the absence and presence of S9-mix, respectively. In tester strain TA1535, the substance induced an up to 2.0- fold, dose related increase in the number of revertant colonies compared to the solvent control in the absence of S9-mix and an up to 4.9-fold, not dose-related increase in the presence of S9-mix. In the other three tester strains (TA1537, TA98 and WP2uvrA) in the absence and presence of S9-mix, the substance did not induce a dose-related increase in the number of revertant colonies.
Based on the results of this study it is concluded that the substance is mutagenic in the bacterial reverse mutation assay.
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