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EC number: 224-314-4 | CAS number: 4303-67-7
- 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:
- 18 September 2014 to 29 September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This USFDA and OECD GLP compliant study was performed according to OECD 471 (1997).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- MTDID 13999
- IUPAC Name:
- MTDID 13999
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 13999
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 99.0%
- Purity test date: 09 February 2009
- Lot/batch No.: Lot: 529783
Constituent 1
Method
- Target gene:
- Histidine operon
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:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Initial toxicity-mutation assay: 1.5, 5.0, 15, 50, 150, 500, 1500, and 5000 ug/plate.
Confirmatory mutagenicity assay: 0.15, 0.5, 1.5, 5.0, 15, 50, and 150 ug/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: Based on solubility information from the sponsor and compatability with target cells.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- All Strains with S9 Mix: 2-aminoanthracene. Without S9 Mix: TA98: 2-nitrofluorene, TA100 and TA1535: sodium azide, TA1537: 9-aminoacridine, WP2 uvrA: methyl methanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorportation)
DURATION
- Preincubation period: Overnight
- Exposure duration: Initial assay: 56.92 hours, Confirmatory assay: 61.03 hours
- Expression time (cells in growth medium): Approximately 69-73 hours
- Selection time (if incubation with a selection agent): Initial assay: 56.92 hours, Confirmatory assay: 61.03 hours
- Fixation time (start of exposure up to fixation or harvest of cells):Initial assay: 56.92 hours, Confirmatory assay: 61.03 hours
SELECTION AGENT (mutation assays): Histidine minimal augar
NUMBER OF CELLS EVALUATED: All colonies counted by a Sorcerer Colony Counter utilizing Ames Study Manager software.
DETERMINATION OF CYTOTOXICITY
- Method:Bacterial background lawn condition. - Evaluation criteria:
- For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of test article. Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean revertants at the peak of the dose response was greater than or equal to 3.0-times the mean vehicle control value. Data sets for tester strains TA98, TA100, and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response was greater than or equal to 2.0-times the mean vehicle control value.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicity was observed at test article doses greater than 15 ug per plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation was observed at 1500 ug/plate and higher.
RANGE-FINDING/SCREENING STUDIES: An initial toxicity-mutation assay was conducted up to 5000 ug/plate to determine the appropriate doses for the confirmatory mutagenicity assay.
COMPARISON WITH HISTORICAL CONTROL DATA: Controls were within historical ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY: Cytotoxicity was observed at test article doses greater than 15 ug per plate. - 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
Under the conditions of this study, the test material was not mutagenic in the Bacterial Reverse Mutation Assay. - Executive summary:
The mutagenic potential of the test article (Clear colorless liquid, Lot 529783, 99% CASRN 4303-67-7) was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA1535, and TA1537 and E. coli strain WP2 uvrA in the presence and absence of a metabolic activation system (Aroclor induced S9-mix). The study was performed in compliance with FDA GLP 21 CFR Part 58 and OECD GLP regulations. The test method was based on OECD 471 (1997). Ethanol was used as the vehicle at all test article doses. A toxicity-mutation assay was conducted with the test article up to 5000 ug/plate with all tester strains in the presence and absence of metabolic activation to establish the dose-range for the confirmatory mutagenicity assay. In the confirmatory mutagenicity assay, the test article was tested up to 150 ug/plate in the absence of S9 and up to 500 ug/plate in the presence of S9 with all tester strains. Strain specific positive controls and vehicle controls were tested in parallel. No increase in revertant colonies was observed in either the presence or absence of metabolic activation in any strain tested. All criteria for a valid test were met as described in the protocol. Under the conditions of this study, the test material was not mutagenic in the Bacterial Reverse Mutation Assay.
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