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Diss Factsheets
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EC number: 938-868-6 | 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption
- Type of information:
- other: statement
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An extended assessment of the toxicokinetic behaviour of Cu(2Na)IDHA was performed, taking into account the chemical structure, the available physico-chemical-data and the available toxicity data.
Data source
Reference
- Reference Type:
- other: Statement
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: TGD, Part I, Annex IV, 2003); ECHA guidance R7c., 2008
- Deviations:
- no
- Principles of method if other than guideline:
- An assessment of dermal absorption potential of Cu(2Na)IDHA is based on its physico-chemical properties and on the results of available toxicity data data.
- GLP compliance:
- no
Test material
- Reference substance name:
- disodium 2-[7-(carboxylatomethyl)-4,8-dioxo-1,3-dioxa-6-aza-2-cupracyclooctan-5-yl]acetate
- EC Number:
- 938-868-6
- Cas Number:
- 666828-79-1
- Molecular formula:
- not applicable
- IUPAC Name:
- disodium 2-[7-(carboxylatomethyl)-4,8-dioxo-1,3-dioxa-6-aza-2-cupracyclooctan-5-yl]acetate
- Reference substance name:
- Iminodisuccinic acid copper disodium salt
- IUPAC Name:
- Iminodisuccinic acid copper disodium salt
- Test material form:
- other: microgranulated
Constituent 1
Constituent 2
Results and discussion
Percutaneous absorption
- Parameter:
- percentage
- Absorption:
- ca. 6 %
- Remarks on result:
- other: based on data for copper in an ex vivo study with human skin
Applicant's summary and conclusion
- Conclusions:
- No significant dermal absorption is expected for the target substance.
- Executive summary:
Based on physical – chemical properties of Cu (II) IDHA, the substance is not likely to penetrate skin to a large extent due to its negative logPow: -3.09 and a very high water solubility: 421 g/L. Water solubility above 10.000 mg/L combined with a logPow value below 0 indicate that the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Dermal uptake for these substances will be low. The molecular weight of 354.69 g/mol indicates that a certain potential to penetrate the skin (< 500) exists. However, in case of such a hydrophilic substance dermal penetration is rather unlikely. This is supported by the findings of acute dermal toxicity studies of the target substance Cu (II) IDHA as well as free IDHA and Cu (2Na) EDTA where no systemic toxicity after exposure via the skin was noted (LD50 > 2000 mg/kg bw; Kropidło, 2010, Report No. DER -13/10; Stropp, 1997, Report No. T3061600; Beerens, 2010, Report No. 494023). Moreover, an acute dermal irritation / corrosion study in the rabbit (according to OECD 404) for Cu (II) IDHA did not demonstrate any irritation after 14 days (Kropidło, 2010, Report No. DDR-15/10). This information indicates that Cu (II) IDHA is unlikely to penetrate the skin. In a human study, EDTA-CaNa2 did not penetrate the skin, only 0.001 % was absorbed within 24 hours of administration (RAR, 2004). In case of dissociated complexes, copper ions uptake across intact skin would be expected to be extremely limited (ATSDR, 2004). The available in vivo data do not provide information on the rate and extent of absorption through intact skin following dermal exposure of humans or animals to copper (ATSDR, 2004; SCOEL, 2013). In vitro studies suggest that copper is poorly absorbed through intact skin. Less than 6% of copper deposited on ex vivo human skin samples were absorbed (ATSDR, 2004). Low absorption potential through the skin would also apply to free IDHA chelating agent due to its high hydrophilicity (water solubility of 564 g/L; data for Baypure CX 100 (Bayer)).
Based on very low logPow values, high water solubility and absence of toxicity effects in animal studies conducted with different aminopolycarboxylate chelates: free chelating agent IDHA, Cu (II) IDHA, Cu (2Na) EDTA and Ca (2Na) EDTA, a similar behaviour regarding absorption through the skin is expected. Dermal absorption is considered to be negligible and equal to 6 % established for copper in an ex vivo study with human skin. This is the highest value known which will be used for hazard assessment: DNEL derivation.
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