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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 270-601-2 | CAS number: 68457-13-6
- 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
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Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned (based on read-across)
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Neodecanoic acid, Cobalt salt
- Name of the substance for which the testing proposal will be used: all members of the group of the poorly soluble with organic ligand (PS-OL) cobalt substances
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: no GLP pre-natal developmental toxicity studies are available for any of the members of the PS-OL group
- Available non-GLP studies: no non-GLP pre-natal developmental toxicity studies are available for any of the members of the PS-OL group
- Historical human/control data: no information in humans on the developmental toxicity are available for any of the members of the PS-OL group
- (Q)SAR: QSAR methods are not applicable to inorganic metal substances
- In vitro methods: In vitro methods, replacing such a complex test design of a pre-natal developmental toxicity study are not available (see http://alttox.org/mapp/toxicity-endpoints-tests/reproductive-developmental-toxicity/ and http://eurl-ecvam.jrc.ec.europa.eu/eurl-ecvam-recommendations)
- Weight of evidence: three screening for reproductive/developmental toxicity studies are available for the PS-OL group. 'However, in light of available evidence relating to failure of maintaining pregnancies in the presence of mild to moderate maternal toxicity in the bioavailable Co substances group (BCoS), the conduct of a pre-natal developmental toxicity study with a PS-OL substance is required to clarify the hazard potential for developmental toxicity of that substance group.
- Grouping and read-across: The test substance Neodecanoic acid, Cobalt salt is used as source substance of the PS-OL group.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: not applicable
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Criteria given in Annex IX, Column 2, Section 8.7 Reproductive toxicity:
— the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or: Neodecanoic acid, Cobalt salt not a genotoxic carcinogen.
— the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented, or: Neodecanoic acid, Cobalt salt is not a germ cell mutagen. There is no convincing evidence that Neodecanoic acid, Cobalt salt shows somatic or germ cell mutagenicity with relevance for humans.
— the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure. All available studies for the read-across group poorly soluble in aqueous solutions with organic ligand cobalt substances show adverse effects as follows: (i) Decreased body weight and food consumption, clinical signs of toxicity (ii) Intestinal effects including the following diagnoses: degeneration/necrosis of mucosal epithelium (villous and crypt epithelium); atrophy of villi and crypts; regeneration of mucosal epithelium, and mucosal inflammation. Based on this, a “low toxicological activity” statement is not warranted. Neodecanoic acid, Cobalt salt has been selected as source substance for the “poorly soluble in aqueous solutions with organic ligand” cobalt substance group. Findings from this study will be read-across to all other members of that group and subsequent conclusions for classification & labelling and DNEL derivation will be adopted accordingly (worst case approach). For further information on the oral read-across approach, please refer to Section 13.2 of the IUCLID.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Neodecanoic acid, cobalt salt
- EC Number:
- 248-373-0
- EC Name:
- Neodecanoic acid, cobalt salt
- Cas Number:
- 27253-31-2
- Molecular formula:
- Molecular and structural formula as well as molecular weight are not applicable to a UVCB substance.
- IUPAC Name:
- Neodecanoic acid, cobalt salt
Constituent 1
Test animals
- Species:
- rat
Results and discussion
Applicant's summary and conclusion
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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