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EC number: 701-411-4 | 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:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See the documentation for the category approach.
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See the documentation for the category approach.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- copper sulfate;N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine
- EC Number:
- 701-400-4
- Molecular formula:
- C8H23N5CuSO4
- IUPAC Name:
- copper sulfate;N'-[2-[2-(2-aminoethylamino)ethylamino]ethyl]ethane-1,2-diamine
Constituent 1
Method
- Target gene:
- his C, his D, his G and tryp E
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 1537
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction, microsome fraction prepared from Sprague Dawley rat liver homogenate, is provided by MOLTOXTM (POB Box 1189 - 157 Industrial Park Dr - Boone, NC 28607 - USA) (S9 Moltox-11101-5-3805 validated on 07.2017 – expiry date: 25.05.2019).
- Test concentrations with justification for top dose:
- 5000, 3000, 1500, 500, 150 and 50 μg.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:
for test item: water
for controls: DMSO (Sigma-D5879- SZBG1310V), Acetone (CARLOERBA- P0051010- D7A063237A) and NaCl 0.15M (DUTSCHER- 06981713-3012587)
- Justification for choice of solvent/vehicle:
highly soluble in water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Anthramine and cis-Platinum (II) Diammine Dichloride
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): 1-9 x10^8 bacteria
DURATION
Plates are incubated at 37° C over a 48-72 hour period.
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: number of colonies/plate - Rationale for test conditions:
- Protocol test conditions.
- Evaluation criteria:
- Ensure that the criteria of validity of the study are well respected namely:
the bacteriostatic activity of the highest concentration tested shall be equal to or less than 75 %,
the spontaneous reversion rate of the absolute negative control shall comply with the historical values of the laboratory,
the spontaneous reversion rate of the solvent shall not be statistically different from absolute negative control,
the mean number of revertant colonies obtained for each strain and the corresponding positive control, with and/or without metabolic activation shall comply with the historical values of the laboratory.
Negative and positive values should not show significant difference with the historical values of the laboratory (± 2 standard deviations). - Statistics:
- no statistics were performed
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- at 3000 and 5000 microgram/L
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity compatible with the maximum tolerated 75% in the presence of the higher dose 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity compatible with the maximum tolerated 75% in the presence of the higher dose 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- At 3000 and 5000 microgram/L
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity compatible with the maximum tolerated 75% in the presence of the higher dose 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity compatible with the maximum tolerated 75% in the presence of the higher dose 5000 μg/plate
- 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:
- cytotoxicity
- Remarks:
- cytotoxicity compatible with the maximum tolerated 75% in the presence of the higher dose 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity compatible with the maximum tolerated 75% in the presence of the higher dose 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity compatible with the maximum tolerated 75% in the presence of the higher dose 5000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Sterility controls
1. Test items: Results show the absence of any bacterial growth in the presence of the various concentrations of the test item.
2. "S9-mix": Results show the absence of any bacterial growth in the presence of "S9-mix".
Bacteriostatic activity control
Results show a cytotoxicity compatible with the maximum tolerated 75% in the presence of the higher dose 5000 μg/plate. The test item is tested at these doses (5 000, 1 500, 500, 150 and 50 μg/plate) for the first assay. Due to the result of the first assay (increase in the number of revertant colonies in Salmonella typhimurium TA 1535, TA 98 and TA 100), one supplementary dose of 3000 μg/plate is studied for the second assay in Salmonella typhimurium TA 1535, TA 98 and TA 100.
Mutation assay interpretation
* There is no significant difference between the number of spontaneous reversions, the number of reversions obtained for the positive controls (without and with metabolic activation), and the mean of corresponding experimental historical values obtained in the laboratory.
* There is an increase in the number of revertant colonies in the presence of the higher dose of the test item (5 000 μg/plate) without metabolic activation in Salmonella typhimurium TA 1535, and TA 100.
* Results are confirmed in an independent experiment with the dose of 3 000 μg /plate.
Applicant's summary and conclusion
- Conclusions:
- Solutions of the test item Reaction product of copper sulfate and tetraethylenepentamine BATCH: 170432 (LEMI code: GQQ021117), provided by BMS MICRO-NUTRIENTS NV, induce a mutagenic change in Salmonella typhimurium TA 1535 and TA 100 without metabolic activation, according to the OECD Guidelines n°471.
- Executive summary:
Solutions obtained from GQQ021117, have been tested for their capacity to induce reverse mutation in four Salmonella typhimurium strains and one Escherichia coli WP2 (uvr Ā) (pKM101) strain. This study was performed in the absence and presence of metabolic activation. Two independent assays were carried out:
For assay n° 1, various concentrations of were put in contact with the strains in the absence and presence of a metabolic activation system (S9-mix 10% (v/v)).
For assay n° 2, various concentrations of were put in contact with the strains in the absence of metabolic activation and with pre-incubation in the presence of metabolic activation system (S9-mix 10% (v/v)).
For the two assays, negative and positive controls were carried out in parallel. Positive controls induced a significant increase in the number of revertant colonies compared to negative controls. There is no significant difference between the number of spontaneous reversions, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponding experimental“historical”values obtained in the laboratory.
These results validate the two tests.
There is an increase in the number of revertant colonies in the presence of the higher dose of the test item (5 000 μg/plate) without metabolic activation in Salmonella typhimurium TA 1535 and TA 100. Results are confirmed in an independent experiment with the dose of 3 000 μg /plate.Conclusion:
Solutions of the test item Reaction product of copper sulfate and tetraethylenepentamine BATCH: 170432 (LEMI code: GQQ021117), provided by BMS MICRO-NUTRIENTS NV, induce a mutagenic change inSalmonella typhimuriumTA 1535 and TA 100 without metabolic activation, according to the OECD Guidelines n°471.
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