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EC number: 233-382-4 | CAS number: 10138-04-2
- 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:
- 11/06/2018 - 20/07/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- OECD Guideline for the Testing of Chemicals, Version 439, adopted 28. July 2015,“In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method”
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EU) No. 640/2012 amending Regulation (EC) No.440/2008, Annex III, EU method B.46 “IN VITRO SKIN IRRITATION: RECONSTRUCTEDHUMAN EPIDERMIS MODEL TEST”, adopted 06. Jul. 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 7783-83-7
- Molecular formula:
- NH4Fe(SO4)2 • 12 H2O
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Name: Ammonium iron bis(sulphate) Dodecahydrate; Batch no.: 114123; Appearance: Pale violet lumps; Purity: Reagent grade, 99.6% (test data from supplier); Homogeneity: homogeneous; Expiry date: 05. Oct. 2018; Storage: Room Temperature (20 ± 5°C); Keep away from light;
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: human-derived epidermal keratinocytes
- Cell source:
- other: EpiDerm tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava. Designation of the kit: EPI-200-SIT; Day of delivery: 17. Jul. 2018; Batch no.: 28634
- Details on test system:
- Chemicals and Media: MTT: 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide (=MTT), which can be reduced to a blue formazan. A MTT stock solution of 5 mg/mL in DPBS buffer was prepared and stored in aliquots of2 mL in the freezer (– 20 ± 5 °C). 2 mL of the stock solution were thawed and diluted with 8 mL of medium. This MTTsolution with the resulting concentration of 1 mg/mL was used in the test. For the pre-test (testing the ability of direct MTT reduction), the stock solution was thawed and diluted with serum-free MEM directly before use.For the main test, the stock solution was thawed and diluted with assay medium directly before use.MEM with Phenol Red for Pre-Test: Serum-free MEM (Minimum Essential Medium), procured by Life Technologies GmbH, batch no.: 1880322. Assay Medium: Serum-free DMEM (Dulbecco’s Modified Eagle’s Medium), procured by MatTek In VitroLife Science Laboratories, batch no.: 071218MSA. Isopropanol: CH3-CH(OH)-CH3, p.A., 99.9 %, batch no.: 276245555, used as extracting solvent for formazan. DPBS-buffer: Solution for the rinsing of the tissues and solvent for MTT concentrate, also used as negative control. A subset was procured by MatTek In Vitro Life Science Laboratories; the other subset was prepared by LAUS GmbH. Composition of the subset from MatTek In Vitro Life Science Laboratories (batch no.: 071018MSA): KCl 0.2 g, KH2PO4 0.2 g, NaCl 8.0 g, Na2HPO4 * 7H2O 2.16 g, H2O ad 1 L.Composition of the subset from LAUS GmbH (batch no.: 20171114): KCl 0.2 g, KH2PO4 0.2 g, NaCl 8.0 g, Na2HPO4 * 2H2O 1.44 g, H2O ad 1 L. The buffer which was procured by MatTek Corporation was used as negative control and for rinsing the test item from the tissues. The buffer which was prepared by LAUS GmbH was used as solvent for MTT concentrate and for rinsing the outside of the inserts at the end of the incubation time with MTT.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Tissue 1: 27.1 mg; Tissue 2: 26.8 mg; Tissue 3: 27.3 mg
- Duration of treatment / exposure:
- 1 h
- Duration of post-treatment incubation (if applicable):
- 23 h 20 min
- Number of replicates:
- 1
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 1
- Value:
- 77.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 2
- Value:
- 78.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 3
- Value:
- 86
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean (tissue 1-3)
- Value:
- 80.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Skin irritation potential of the test item is assessed as: if the tissue viability is ≤ 50 % of negative control the test material is regarded as Corrosive/Irritant to skin (Category 1 or 2) according to UN GHS. At tissue viabilities above 50 % of the negative control the test material is regarde as non-irritant to skin.
Any other information on results incl. tables
OD @ 570 nm: Blank isopropanol: 0.038
Designation | Measurement | Negative Control | Test material | Positive control |
Tissue 1 | 1 | 1.593 | 1.268 | 0.080 |
Tissue 1 | 2 | 1.561 | 1.321 | 0.096 |
Tissue 2 | 1 | 1.808 | 1.306 | 0.090 |
Tissue 2 | 2 | 1.834 | 1.298 | 0.084 |
Tissue 3 | 1 | 1.564 | 1.433 | 0.088 |
Tissue 3 | 2 | 1.580 | 1.428 | 0.088 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean value of relative tissue viability of the test item was reduced to 80.6% after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as non-irritant to skin.
- Executive summary:
The skin irritation potential of ammonium iron bis(sulphate) dodecahydrate was assessed in a study on reconstructed human epidermis according to EU and OECD guidelines. The test item Ammonium iron bis(sulphate) Dodecahydrate is considered as non-irritant to skin. After the treatment, the mean value of relative tissue viability was reduced to 80.6%. This value is above the threshold for skin irritation (50%). The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8. The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%). For these reasons, the result of the test is considered valid.
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