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EC number: 257-446-6 | CAS number: 51818-55-4
- 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 corrosion: in vitro / ex vivo
- Remarks:
- An Assessment of in vitro Skin Corrosion using EpiDerm™
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experimental Start Date: 30 August 2017 Experimental Completion Date: 31 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Method 431 (adopted 29 July 2016) and Method B40 bis of Council Regulation (EC) No 440/2008. An Assessment of in vitro Skin Corrosion using EpiDerm™
- Version / remarks:
- An Assessment of in vitro Skin Corrosion using EpiDerm™
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- The study was conducted in compliance with UK Good Laboratory Practice Regulations 1999, Statutory Instrument 1999 No. 3106; as amended by the Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004, Statutory Instrument 2004 No. 994
Test material
- Reference substance name:
- Neodecanoic acid, iron salt
- EC Number:
- 257-446-6
- EC Name:
- Neodecanoic acid, iron salt
- Cas Number:
- 51818-55-4
- Molecular formula:
- C10H20O2.xFe
- IUPAC Name:
- λ²-iron(2+) bis(2-ethyl-2,5-dimethylhexanoate)
- Test material form:
- solid
- Details on test material:
- CAS Number: 51818-55-4
EC Number 257-446-6
Molecular formula: C30H57FeO6
Molecular weight: 569.6
Purity: 100%
Storage conditions: Refrigerated under Nitrogen ( 2-8 °C )
Constituent 1
- Specific details on test material used for the study:
- Storage 2 to 8°C protected from light, under nitrogen
Batch Number LN11013894
Retest Date 31 July 2019
Purity 100%
In vitro test system
- Test system:
- human skin model
- Remarks:
- human skin model, comprising a reconstructed epidermis with a functional stratum corneum
- Source species:
- other: in vitro skin model EpiDermTM
- Details on animal used as source of test system:
- Human skin model, comprising a reconstructed epidermis with a functional stratum corneum
- Vehicle:
- other: The test article was administered without dilution
- Control samples:
- other: A volume of 50 µL of the undiluted test article was applied to the tissue. Further tissues were concurrently treated with 50 µL distilled water (negative control) and with 50 µL 8N potassium hydroxide (positive control).
- Amount/concentration applied:
- A volume of 50 µL of the undiluted test article was applied to the tissue. Further tissues were concurrently treated with 50 µL distilled water (negative control) and with 50 µL 8N potassium hydroxide (positive control).
- Duration of treatment / exposure:
- 3 minute or 1-hour contact periods
- Duration of post-treatment incubation (if applicable):
- incubated for 3 hours (37±1Deg C, 5±1% CO2, 95% RH).
The additional control tissues were incubated with medium instead of MTT solution
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: Skin viability was 86% after three minute and one hour exposures to the test article.
- Value:
- 86
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The OD values for the negative controls met the acceptance criteria, with the exception that the mean OD value for the three minute treatment was just below the range of 0.8 to 2.8 specified in the protocol. However, the result was within the laboratory historical control range of 0.486 to 2.154 and it was considered that the experiment was valid.
Skin viability after the one hour exposure to the positive control article was <15%.
The CV between the replicates should be =30%.
Any other information on results incl. tables
Please see attached OD and Cell Viability Results - Three Minute Exposure Period & OD and Cell Viability Results - One Hour Exposure Period
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article was considered to be non-corrosive according to the UN GHS classification system.
- Executive summary:
This study was conducted to determine whether the test article causes corrosion in thein vitro skin model EpiDermTM.
Duplicate EpiDermTM inserts were treated with test article, purified water (negative control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At the end of the treatment period, the tissues were washed with phosphate buffered saline (PBS) and cell viability was assessed using the MTT assay. The skin corrosivity potential was classified according to the remaining cell viability obtained after test material treatment with either of the two treatment times.
Skin viability was 86% after three minute and one hour exposures to the test article.
The OD values for the negative controls met the acceptance criteria, with the exception that the mean OD value for the three minute exposure was just below the range of 0.8 to 2.8 specified in the protocol. However, the result was within the laboratory historical control range of 0.486 to 2.154 and it was considered that the experiment was valid.
Skin viability after a three minute or one hour exposure to the positive control article was 8% and 10%, respectively, demonstrating an acceptable performance of the assay.
The test article was considered to be non-corrosive according to the UN GHS classification system.
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