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EC number: 614-455-3 | CAS number: 68411-07-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 May 2010 to 25 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Compliant to GLP and testing guideline (the minor deviation observed, a 4-minute exposure instead of a 3-minute exposure, did not impact the reliability of the study as the test material was not corrosive at any of the exposure times); adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 431 Guideline "In vitro skin corrosion: Human skin model test"
- Deviations:
- yes
- Remarks:
- A '-minute exposure was conducted instead of a 3 minute-exposure
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Copper Lead Resorcylate Salicylate Complex
- EC Number:
- 614-455-3
- Cas Number:
- 68411-07-4
- Molecular formula:
- C7H5O4-, C7H5O3- Cu , Pb
- IUPAC Name:
- Copper Lead Resorcylate Salicylate Complex
- Details on test material:
- - Name of test material (as cited in study report): lead-copper-resorcylate-salicylate
- Substance type: multicontituent
- Physical state: pale green powder
- Composition of test material, percentage of components: 11.9% of copper, 35.7% of lead, 14.1% of resorcylate and 35.7% of salicylate
- Lot/batch No.: 09/201
- Expiration date of the lot/batch: 04 November 2011
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg of the solid test material was applied topically to the corresponding tissues ensuring uniform coverage of the tissues. - Duration of treatment / exposure:
- 4, 60 and 240 minutes
- Number of animals:
- Not applicable
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability in percentage (based on optical density (absorbance) at 540 nm)
- Value:
- 95
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 4 minutes. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability in percentage (based on optical density (absorbance) at 540 nm)
- Value:
- 86.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 minutes. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability in percentage (based on optical density (absorbance) at 540 nm)
- Value:
- 69.8
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 240 minutes. Reversibility: other: not applicable. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- The test material was considered to be Non-Corrosive to the skin and assigned the EU risk phrase of No label, UN packing group Non-Corrosive and a CLP risk phrase regulation of Non-corrosive.
- Executive summary:
Introduction:
The purpose of this test is to evaluate the corrosivity potential of the test material using the EPISKINTMin vitro Reconstituted Human Epidermis (RHE) Model after treatment periods of 4, 60 and 240 minutes. This method was designed to meet the requirements of the following guideline:
- OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004)
The EPISKINTMmodel is able to distinguish between corrosive and non-corrosive chemicals for all of the chemical types studied. As stated in regulation 1272/2008/EEC a validated in vitro test such as in vitro skin corrosion test in the EPISKINTMmodel can be used for classification and labelling. The EPISKINTMmodel is also able to distinguish between known R35 (UN packing group I) and R34 (UN packing group II & III) chemicals.
Methods:
Duplicate tissues were treated with the test material for exposure periods of 4, 60 and 240 minutes. At the end of the exposure period the test material was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µl samples were transferred to the appropriate wells of a pre‑labelled 96‑well plate. The optical density was measured at 540 nm.
Data are presented in the form of percentage viability (MTT reduction in the test material treated tissues relative to negative control tissues).
Results:
The relative mean viability of the test material treated tissues was:
4 minutes exposure: 95.0%
60 minutes exposure: 86.3%
240 minutes exposure: 69.8%Quality criteria:
The quality criteria required for acceptance of results in the test were satisfied.
Discussion:
The protocol instructed a 3 minute exposure to be conducted. However, in error a 4 minute exposure was conducted. As the test material was non-corrosive after prolonged 60 and 240 minute exposures and clearly non-corrosive after a 4 minutes exposure the purpose of this study was considered to have been achieved and the integrity of the study was considered acceptable.
Conclusion:
The test material was considered to be Non-Corrosive to the skin and assigned the EU risk phrase of No label, UN packing group Non-Corrosive and a CLP risk phrase regulation of Non-corrosive.
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