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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guidline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- Salmonella typhimurium TA98, TA100, TA1535 and TA1537: GC
Escherichia coli WP2 uvrA: AT
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:
- S9 mix (rat)
- Test concentrations with justification for top dose:
- 1.581, 5, 15.81, 50, 158.1, 500, 1581, 5000 μg/plate
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO):
Supplier: Sigma-Aldrich Co.
Batch No.: SZBD1830V
Expiry date: 16 June 2016
Grade: puriss, p.a., ACS reagent
Purity: 100.0%
Distilled water:
Manufacturer: TEVA Hungary Ltd.
Batch No.: 0790713 / 0271113
Expiry date: 31 July 2016 / 30 November 2016
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, Distilled Water
- Positive controls:
- yes
- Remarks:
- 2µg
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535, without metabolic activation
- Positive controls:
- yes
- Remarks:
- 50µg
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537, without metabolic activation
- Positive controls:
- yes
- Remarks:
- 2µL
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA, without metabolic activation
- Positive controls:
- yes
- Remarks:
- 4µg
- Positive control substance:
- other: 4-nitro-1,2-phenylene-diamine (NPD)
- Remarks:
- TA 98, without metabolic activation
- Positive controls:
- yes
- Remarks:
- 2µg
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Remarks:
- TA 98, TA 100, TA 1535, TA 1537, with metabolic activation
- Positive controls:
- yes
- Remarks:
- 50µg
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Remarks:
- WP2 uvr2, with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: 1st main experiment: in agar (Plate Incorporation Method); 2nd main experiment: Plate Incorporation Method instead of
Pre-Incubation Method due to the limited solubility of the test item.
DURATION
- 1st main experiment: 48±1 hours incubation (37°C)
- 2nd main experiment: 48±1 hours incubation (37°C)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
The colony numbers on the untreated / negative (vehicle/solvent) / positive control and test item treated plates were determined by manual
counting. Visual examination of the plates was also performed; precipitation or signs of growth inhibition (if any) were recorded and reported. - Evaluation criteria:
- The study was considered valid if:
-the number of revertant colonies of the negative (vehicle/solvent) and positive controls were in the historical control range in all strains of the main tests;
-at least five analyzable concentrations were presented in all strains of the main tests.
Criteria for a Positive Response:
A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurred and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurred in at least one strain with or without metabolic activation.
An increase was considered biologically relevant if:
- the number of reversions was more than two times higher than the reversion rate of the negative (vehicle/solvent) control in Salmonella typhimurium TA98,
TA100 and Escherichia coli WP2 uvrA bacterial strains;
- the number of reversions was more than three times higher than the reversion rate of the negative (vehicle/solvent) control in Salmonella typhimurium
TA1535 and TA1537 bacterial strains.
Criteria for a Negative Response:
A test item was considered non-mutagenic if it produced neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation.
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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- 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 and without metabolic activation
In conclusion, the test item Oxophos 64i had no mutagenic activity in the examined bacterial strains under the test conditions of this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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