Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 292-985-0 | CAS number: 91031-79-7
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No genetic toxicity study with fatty acids, C9-13-neo-, copper salts is available, thus the genetic toxicity will be addressed with existing data on the individual assessment entities copper and neodecanoate. As detailed in the RAAF report, neodecanoic is considered as representative of fatty acids, C9-13-neo-. Fatty acids, C9-13-neo-, copper salts is not expected to be genotoxic, since the two moieties copper and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in vitro clastogenicity.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Copper
Copper II sulphate pentahydrate was assayed for mutation in 5-histaidine requiring strains (TA98, TA100, TA1537 and TA102) of Salmonella typhimurium, both in the presence and absence of metabolic activation by Aroclor 1254 -induced rat liver post-mitochondrial fraction (S-9) in 2 separate experiments. Following a range finding study, two experiments were carried out with concentrations of 1.6, 8, 40, 200 and 1000 µg/l in experiment one and 50, 100, 200, 400 and 800 µg/l in experiment two. The tests were carried out in triplicate. Both positive and negative controls were included. None of the dose concentrations in any of the test strains in either the absence or presence of S-9 resulted in an increase in revertant numbers that were statistically significant at the 1% level when analysed using a Dunnett’s test. It was therefore concluded that copper II sulphate pentahydrate was unable to induce mutation in 5 strains of S. typhimurium, when tested at concentrations extending to the toxic range, in both the absence and presence of rat liver metabolic activation system.
Copper II sulphate pentahydrate was tested for its ability to induce unscheduled DNA synthesis (UDS) in the livers of orally dosed male rats using an in vivo/in vitro procedure. Groups of 6 male rats were treated once with copper sulphate at 632.5 or 2000 mg/kg by oral gavage at a dose volume of 10 ml/kg. For the negative control, a further 6 male rats received purified water as a negative control at the same dose volume. Positive control animals for the 12-14 hour experiment, 6 male rats were dosed orally with 75 mg/kg 2 -acetamidofluorene, suspended in corn oil. Dimethylmitrosamine, dissolved in purified water, was the positive control for the 2-4 hour experiment.
Approximately 12-14 hours (experiment 1) or 2-4 hours (experiment 2) after dose administration the animals were sacrificed and the livers perfused with collagenase to provide a primary culture of hepatocytes. The net grain count, number of grains present in the nucleus, minus the mean number of grains in 3 equivalent areas of cytoplasm were determined.
Negative control animals gave a group mean net grain of less than 0 with no cells in repair. Group mean net grain values were increased by both positive controls to more than 5 with more than 50% of cells found to be in repair. This was consistent with historical control data.
Treatment with 632.5 or 2000mg/kg copper sulphate pentahydrate (equivalent to 161 or 509 mg Cu/kg) did not produce a group mean net grain value greater than -1.0 nor were any more than 1.0% cells found in repair at either dose.
Copper II sulphate pentahydrate was assayed in vivo in a mouse bone marrow micronucleus test at a single dose level of 447 mg/kg (113.76 mg Cu/kg) for two consecutive days to groups of 5 male and 5 female mice sacrificed 24 or 48 hours after the second administration. Both negative (purified water) and positive controls (cyclophosphamide) were included in the study. The study was conducted according to EEC Annex V test B12 guidelines and in compliance with GLP.
Mice treated with copper II sulphate pentahydrate exhibited frequencies of micronucleated polychromatic erthrocytes which were similar to vehicle controls at all sampling times. There were no instances of statistically significant increases in micronucleus frequency for any group receiving the test chemical at either sampling point.
Based on these results no classification for genetic toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.
Neodecanoate
Neodecanoic acid is not mutagenic in vitro in bacterial mutation assays (with and without metabolic activation) and was not clastogenic in a cytogenetic assay. Although a test on in vitro gene mutation in mammalian cells is not provided, the bacterial reverse mutation test covering the same endpoint did not show any sign of mutagenic potential with an without metabolic activation. This data suggests that neodecanoic acid is not genotoxic in vitro and likely not genotoxic in vivo.
No classification for genetic toxicity is indicated according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008.
Fatty acids, C9-13-neo-, copper salts
Fatty acids, C9-13-neo-, copper salts is not expected to be genotoxic, since the two assessment entities copper and neodecanoic acid have not shown gene mutation potential in bacteria and mammalian cells as well as in in vitro clastogenicity. Further testing is not required. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.
Justification for classification or non-classification
Fatty acids, C9-13-neo-, copper salts is not expected to be genotoxic, since the two assessment entities copper and neodecanoic acid have not shown gene mutation potential in in vitro tests. Thus, fatty acids, C9-13-neo-, copper salts is not to be classified according to regulation (EC) 1272/2008 as germ cell mutagen.
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.