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EC number: 604-942-9 | CAS number: 15414-04-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Copper, diamminebis(nitrato-kO)
- EC Number:
- 604-942-9
- Cas Number:
- 15414-04-7
- Molecular formula:
- CuH6N4O6
- IUPAC Name:
- Copper, diamminebis(nitrato-kO)
Constituent 1
Method
- Target gene:
- HIS locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- hepatic microsomes from rat livers induced by Aroclor 1254
- Test concentrations with justification for top dose:
- 0, 50, 150, 500, 1500, 5000 µg/plate in the first assay (with and without metabolic activation) and in the second assay (without metabolic activation)
0, 15, 50, 150, 500, 1500, 5000 µg/plate in the second assay (with metabolic activation with pre-incubation)
Justification for top dose: The test item MNP-363 induced no toxicity on the background growth whatever the dose and the strain tested, both with and without metabolic activation, except a slight toxicity in strain TA100 in presence of metabolic activation at the highest dose of 5000 µg/plate. Moreover, marked decreases in the number of revertants were noted when compared to the solvent control in strains TA100 and TA102, both with and without S9-mix. Therefore, the maximum dose retained for the first mutagenicity assay was maintained at 5000 µg/plate in all strains both with and without metabolic activation. - Vehicle / solvent:
- sterile water
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-anthramine
- Details on test system and experimental conditions:
- 2 independent assays performed with and without metabolic activation, the second assay with S9-mix being performed according to the pre-incubation protocol due to negative results in the first assay.
- Rationale for test conditions:
- Test conditions according to OECD guideline 471
- Evaluation criteria:
- A test item is considered to be clearly positive if, in any of the experimental conditions examined all the following criteria are fulfilled:
- at least one of the test doses exhibits a biologically significant increase (2 or 3 fold increase in the mean number of revertants depending on the strain) compared with the concurrent negative control and,
- the increase is dose-related,
- and the mean numbers of revertants of the test doses are outside the distribution of negative control data - Statistics:
- Dunnett's method (Mahon et al, 1989) was used to allow comparison of the mean value for each dose to the mean value for the corresponding solvent control.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in the 2nd assay with metabolic activation, slight toxicity at 1500 µg/plate and important toxicity at 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in the 2nd assay with metabolic activation, slight toxicity at 1500 µg/plate and important toxicity at 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in the 2nd assay with metabolic activation, slight toxicity at 1500 µg/plate and important toxicity at 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the 1st assay, slight toxicity at 5000 µg/plate (- S9 mix) and moderate toxicity at 5000 µg/plate (+ S9 mix). In the 2nd assay (+ S9 mix), slight toxicity at 1500 µg/plate and important toxicity at 5000 µg/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in the 2nd assay with metabolic activation, slight toxicity at 1500 µg/plate and important toxicity at 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the first assay, some statistically significant decreases in the number of revertants were noted in all strains (except in strain TA1537) with and/or without metabolic activation.
In the second assay, in strains TA1537, TA98 and TA102, a very important decrease in the number of revertants was noted at 1500 µg/plate. This dose was thus not exploitable for the assessment of mutagenicity.
To end, some statistically significant decreases in the number of revertants were noted in strains TA98, TA100 and TA102 with and/or without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- The mutagenic activity of the test item MNP-363 was assessed by means of the Ames’ test in the five Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 tested both in presence and in absence of metabolic activation, in two independent assays according to OECD guideline (OECD 471, 1997), using either the maximum recommended dose, or the highest dose compatible with the toxic activity of the test item (i.e. 1500 or 500 µg/plate).
The validity criteria for the assay were considered as fulfilled. The study is thus valid. Under these experimental conditions, no mutagenic activity was revealed.
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