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EC number: 457-320-2 | CAS number: -
- 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:
- 10 April 2003 to 7 May 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- Batch: MRD-02-375
Expiry date: Feb 2008
Viscous black liquid
Constituent 1
Method
- Target gene:
- histidine locus (S. typimurium strains), tryptophan locus (E. coli)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- post-mitochondrial fraction derived from Aroclor 1254-induced rat liver (S-9 mix).
- Test concentrations with justification for top dose:
- Range-finding study: 0, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Study 2: 0, 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: hexane
- Justification for choice of solvent/vehicle: due to the insolubility of the test substance in more commonly used solvents
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 Migrated to IUCLID6: 0.5 ug/plate (TA 1535 and TA100)
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 Migrated to IUCLID6: 50 ug/plate (TA1537)
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9 Migrated to IUCLID6: 1 ug/plate (TA98)
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide; 0.05 ug/plate (WP2 uvrA, pKM101)
- Remarks:
- without S9
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene; 2 ug/plate (TA1535), 10 ug/plate (WP2 uvrA pKM101)
- Remarks:
- with S9
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9 Migrated to IUCLID6: 5 ug/plate (TA1537, TA98, TA100)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: none
- Exposure duration: 72 hr
NUMBER OF REPLICATIONS: 3 plates prepared per concentration, two independent studies were carried out
NUMBER OF CELLS EVALUATED: 10(8)/plate
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (background lawn) - Evaluation criteria:
- Considered positive if there was a reproducible increase in revertants of an least twice (three times for TA1535 and TA1537) the vehicle controls.
- Statistics:
- No statistical analysis was performed where the test gave a clear positive or negative result
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Remarks:
- There is historical control data on the vehicle, therefore untreated control not necessary in accordance with the OECD TG 471.
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Remarks:
- There is historical control data on the vehicle, therefore untreated control not necessary in accordance with the OECD TG 471.
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Remarks:
- There is historical control data on the vehicle, therefore untreated control not necessary in accordance with the OECD TG 471.
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Remarks:
- There is historical control data on the vehicle, therefore untreated control not necessary in accordance with the OECD TG 471.
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Remarks:
- There is historical control data on the vehicle, therefore untreated control not necessary in accordance with the OECD TG 471.
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: the first study was a range-finding study
COMPARISON WITH HISTORICAL CONTROL DATA: historical control data was included in the report for the bacterial strains used, the combined data for solvent controls, and for the positive controls - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
In a GLP study conducted according to OECD guideline 471, test material MRD-02-375 (EC# 457-320-2) showed no mutagenic potential in an assay for reverse mutation in bacterial strains, at up to 5 mg/plate with and without S9. - Executive summary:
In a GLP study conducted according to OECD guideline 471, the mutagenic potential of test material MRD-02 -375 (EC#457-320-2) was assessed in a bacterial mutation assay (Ames test).
Up to 5000 micrograms/plate of the test substance (dissolved in hexane) was incubated with S. typhimurium strains TA1535, TA1537, TA98 and TA100 and E. coli strain WP2 uvrA pKM101 in a plate incorporation assay, both with an without a rat liver activation fraction (S9). After 72 hr incubation the revertant colonies were counted using an automated colony counter. Two independent assays were carried out with triplicate plates being prepared for each concentration.
No increases in revertant colonies were observed with the test material compared to the vehicle controls. No cytotoxicity was observed as shown by the presence of a confluent background lawn. The positive control substances showed the expected increases in mutant frequency, indicating the effective performance of the assay.
In conclusion, EC# 457 -320 -2 showed no mutagenic potential in an assay for reverse mutation in bacterial strains, at up to 5 mg/plate with and without S9.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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