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EC number: 208-217-4 | CAS number: 516-03-0
- 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:
- September 2018 to January 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Iron(II) oxalate
- EC Number:
- 208-217-4
- EC Name:
- Iron(II) oxalate
- Cas Number:
- 516-03-0
- Molecular formula:
- C2H2O4.Fe
- IUPAC Name:
- iron(II) oxalate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Purity (calculated on oxygen) : (manganimetry method) : > 99% w/w
- Apparent density (gravimetry method): 0.5-0.70 g/cm3
- Moisture content : less than 10%
- Passing through sieve 180 micron (sieving method) : > 99%
- Residual solvent:-
- Stabilisation: stable
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Oxalate de fer from Bernardy
- Batch No.of test material: Batch No 1800025
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: opaque plastic flask, at ambient temperature
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was applied, as supplied.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Foreskin
- Justification for test system used:
- Test system recommended in the OECD 439 Guideline.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Episkin SA, RHE/S/17 (SkinEthic RHE model)
- Tissue batch number(s): Batch No. 18-RHE-132
- Delivery date: received on 06 November 2018
- Date of initiation of testing: 06 November 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: The test item was applied at room temperature
- Temperature of post-treatment incubation: incubation at 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 42 minutes after the test item application, the nylon mesh was removed and the human epidermises were washed with 25 x 1 mL of DPBS.
- Observable damage in the tissue due to washing: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: The skin samples were placed in 300 μL of a MTT solution at 1.0 mg/mL for 3 hours at 37°C, 5% CO2.
- Incubation time: 41 hours and 20 minutes post-treatment incubation period in fresh medium at 37°C, 5% CO2.
- Spectrophotometer: The measurement of OD was performed using the ELx800 absorbance microplate reader (controlled every year and calibrated if necessary) supplied by BioTek and the validated software Gen5 ELISA V1.05.11 supplied by BioTek.
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The OD values obtained for each test item are used to calculate a percentage of viability relative to the negative control, which is arbitrarily set to 100%.
The results were expressed as a viability percentage compared with the negative control: Viability % = (OD test item / OD negative control) x 100
NUMBER OF REPLICATE TISSUES: Triplicates
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
There is no direct interaction between the test item and MTT.
PREDICTION MODEL / DECISION CRITERIA
The test item is considered as non-irritant to skin in accordance with UN GHS No Category if the mean percent viability after 42 minutes exposure and 42 hours of post-treatment incubation is > 50%.
The test item is identified as requiring classification and labelling according to UN GHS (Category 2) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and the result of a skin corrosion test is “non-corrosive”.
The test item is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and in absence of information on a skin corrosion test. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: dose of 16 mg
VEHICLE
Applied as supplied
NEGATIVE CONTROL
- Amount applied: 16 μL of distilled water – ADL Prochilab - Batch No. 180517
POSITIVE CONTROL
- Amount applied: 16 μL of 5% sodium dodecyl sulfate (SDS)
- Concentration: 5 % SDS - Duration of treatment / exposure:
- 42 minutes at room temperature
- Duration of post-treatment incubation (if applicable):
- 41 hours and 20 minutes post-treatment incubation period in fresh medium at 37°C, 5% CO2.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 100.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
|
ID |
OD |
Mean OD / disc |
Mean OD / product |
Viability % |
Mean viability % |
SD viability |
Conclusion |
Negative control |
SPL 1 |
0.961 1.017 0.948 |
0.975 |
0.884 |
110.3 |
100.0 |
9.2 |
|
SPL 2 |
0.851 0.858 0.871 |
0.860 |
97.2 |
|||||
SPL 3 |
0.809 0.817 0.830 |
0.818 |
925 |
|||||
Positive control |
SPL 4 |
0.009 0.010 0.010 |
0.009 |
0.010 |
1.0 |
1.1 |
0.1 |
Irritant |
SPL 5 |
0.012 0.011 0.011 |
0.011 |
1.2 |
|||||
SPL 6 |
0.010 0.011 0.011 |
0.010 |
1.1 |
|||||
Test item PH-18/0521 |
SPL 16 |
0.797 0.891 0.894 |
0.860 |
0.887 |
97.2 |
100.3 |
8.0 |
Non irritant |
SPL 17 |
0.843 0.846 0.811 |
0.833 |
94.2 |
|||||
SPL 18 |
0.953 0.956 0.993 |
0.967 |
109.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the Regulation EC No. 1272/2008, the test item Oxalate de fer has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required. - Executive summary:
The aim was to evaluate the possible irritating effects of the test item Oxalate de fer after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model). The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 439.
The test item Oxalate de fer was applied as supplied, during 42 minutes, at the dose of 16 mg, to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) previously moistened with 10 μL of distilled water. The application was followed by a rinse with 25 mL of DPBS and a 41 hours and 20 minutes post-incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.
The mean percent viability of the treated tissues was 100.3% (considered as 100%), versus 1.1 % in the positive control (5% Sodium Dodecyl Sulfate).
In accordance with the Regulation EC No. 1272/2008, the test item Oxalate de fer has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.
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