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EC number: 241-221-4 | CAS number: 17169-60-7
- 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:
- - 2020-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 18 June 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydrogen (glycinato-N,O)[sulphato(2-)-O,O']ferrate(1-)
- EC Number:
- 241-221-4
- EC Name:
- Hydrogen (glycinato-N,O)[sulphato(2-)-O,O']ferrate(1-)
- Cas Number:
- 17169-60-7
- Molecular formula:
- C2H5FeNO6S
- IUPAC Name:
- 2-aminoacetate;hydron;iron(2+);sulfate
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Cell source was not reported
- Justification for test system used:
- This test method is able to detect chemicals that cause skin irritation, i.e. produce reversible damage to the skin and allows for hazard identification in accordance with UN GHS “Category 2”. Depending on the regulatory framework it can also be used to identify non-classified chemicals.
- Vehicle:
- other: sterile DBPS
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: reconstituted three-dimensional human skin model EpiDerm™ (MatTek)
- Tissue batch number(s):
- Date of initiation of testing:
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 25 ± min at room temperature and 35 ± 1min at 37°C
- Temperature of post-treatment incubation (if applicable): 37°C for 42 h
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 15 times with DBPS and subsequently submerged three-times with 150 µL DBPS and shaken to remove rests of the test item
- Observable damage in the tissue due to washing:
- Modifications to validated SOP:
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3h ± 5 min
- Spectrophotometer: plate spectrophotometer
- Wavelength: 570 nm
- Filter bandwidth: with a filter band pass of maximum ± 30 nm without reference wavelength
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
- Barrier function:
- Morphology:
- Contamination:
- Reproducibility:
NUMBER OF REPLICATE TISSUES: triplicate
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues
- Procedure used to prepare the killed tissues (if applicable):
- N. of replicates :
- Method of calculation used:
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive /irritant to skin if the viability after 1 hour exposure is less than 50%.
- The test substance is considered to be non-corrosive/irritant to skin if the viability after 1 hour exposure is greater than or equal to 50%. - Control samples:
- yes, concurrent no treatment
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg and 25 µL to moistened the tissue
VEHICLE
- Amount(s) applied (volume or weight with unit): 25 µL DBPS
- Lot/batch no. (if required): Cat. No.: 14040-091
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL DBPS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL SDS solution
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 1h
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- triplicate
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean of three treatments with the test material
- Value:
- 76
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: Not reported
- Direct-MTT reduction:
- Colour interference with MTT:
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Please refer to the 'any other information on results incl. tables' section
- Acceptance criteria met for positive control: Please refer to the 'any other information on results incl. tables' section
- Acceptance criteria met for variability between replicate measurements: Please refer to the 'any other information on results incl. tables' section
- Range of historical values if different from the ones specified in the test guideline:
Any other information on results incl. tables
Results are draft report results which are reported in more detail on the next update
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present in vitro test conducted according to OECD guideline 439, 25 mg ferrous monoglycinate sulfate were applied to human keratinocytes for 1h. Afterwards the cell viability was measured with MTT at 570 nm. The mean measured viability as compared to the negative controls for the test item was 76%, thus the test item is not classified according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS)
- Executive summary:
In a dermal irritation study performed in accordance with OECD Guideline 439 (In Vitro Skin Irritation) (adopted 18 June, 2019), ferrous monoglycinate sulfate (100% a.i.) was applied to the three-dimensional human epidermis model tissue for an exposure period of 1 h in triplicates. 25 μL of DBPS were topically applied to the epidermal surface in order to improve further contact between the solid and the epidermis. Each approximately 25 mg of the test item were applied to the wetted tissues. The test item was spread to match the surface of the tissue.
After 25 minutes exposure at room temperature and 35 minutes at 37°C, the tissues were washed with DBPS to remove any residual test material. Subsequently the tissue constructs were incubated for 42 h at 37°C. Cytotoxicity (irritancy) was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
The positive (5% SDS) and negative (DBPS) control gave responses that were within the acceptance criteria and as such demonstrated the validity of the study.
The relative mean tissue viability obtained after 1h treatment with ferrous monoglycinate sulfate compared to the negative control tissues was 76%. Since the mean relative tissue viability for the test substance was above 50%, ferrous monoglycinate is identified to be not irritating.
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