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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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:
- 02 August 2021 - 02 September 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2021
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ammonium manganese diphosphate, monoclinic and triclinic
- Molecular formula:
- MnKx (NH4)1-x P2O7 (0 =< x =< 0.5)
- IUPAC Name:
- Ammonium manganese diphosphate, monoclinic and triclinic
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- SkinEthic RHE®
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Justification for test system used:
- The SkinEthic RHE® model has been validated for irritation testing (Validation study based on the original ECVAM Performance Standards (21) in 2008) and its use is recommended by the relevant OECD guideline for irritation testing (OECD No. 439); therefore, it was considered to be suitable for this study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE®
- Tissue batch number(s): 21-RHE-138 (living) and 21-RHE-104 (killed)
- Shipping date: 31 August 2021 and 22 June 2021
- Delivery date: 31 August 2021 and 01 September 2021 (defreezing).
- Expiration date: 6 September 2021
- Date of initiation of testing: 01 September 2021
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37ºC
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 25 x 1 mL of DPBS (Dutscher - Batch No. 7380521)
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 μL of a MTT solution at 1.0 mg/mL
- Incubation time: 3 hours and 02 minutes at 37°C, 5% CO2
- Spectrophotometer: ELx800 absorbance microplate reader (BioTek)
- Wavelength: 570 nm
- Filter: no
- Linear OD range of spectrophotometer: not specified.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD = 1.3 (CV = 6.4%), specification OD > 0.7
- Barrier function: > 10.0h (pecification 4.0 ≤ ET50 ≤ 10.0h); ET50 value was out of specification but declared satisfactory by dispensation. Quality of the RHE batch is good according to 2 further QC tests (normal values), especially histology showing good morphology.
- Morphology: 6.5 cell layers (specification ≥ 4); multi-layered, highly differentiated epidermis consisting of organized basal, spinous and granular layers, and a multilayered stratum corneum.
- Contamination: no, on the blood of the donors and the cells from the donors, absence of contamination was verified.
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- 2 killed tissues
- Procedure used to prepare the killed tissues (if applicable): 2 killed Human skin model surfaces were treated in the same manner as the living tissues in order to generate non-specific MTT reduction.
- N. of replicates: 2
- Method of calculation used: True viability % = [(living tissues OD exposed to test item - killed tissues OD exposed to test item)/living tissues OD exposed to negative control] x 100
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin (or corrosive) if the viability after 42 minutes exposure and 42 hours of post-treatment incubation is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability after 42 minutes exposure and 42 hours of post-treatment incubation is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 mg (32 mg/cm2) (+10 μL distilled water)
- Vehicle: no
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 μL of distilled water (ADL Prochilab, Batch No. 201117)
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 μL of 5% SDS.
- Concentration (if solution): 5% SDS solution was prepared by weighing 0.5000 g of SDS (SIGMA Batch No. STBJ3028) in a 10 mL volumetric flask q.s. 10 mL of distilled water - Duration of treatment / exposure:
- 42 min
- Duration of post-treatment incubation (if applicable):
- 41 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean (42 min exposure)
- Value:
- 94.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100% viability (distilled water)
- Positive controls validity:
- valid
- Remarks:
- 1.8% viability (5% SDS)
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: yes (relevant control added)
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: yes. A full demonstration of proficiency was
performed for the EpiSkin-SM model, plus a reduced validation with the SkinEthic RHE model.
Adequate results were obtained for the evaluated chemicals.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes. Mean OD of the tissue replicates treated with
the negative control was in the range ≥ 0.8 and ≤ 3.0.
- Acceptance criteria met for positive control: yes. Mean viability of the tissue replicates treated
with the positive control (SDS 5%), expressed as % of the negative control was < 40%
- Acceptance criteria met for variability between replicate measurements: yes. Standard deviation
between tissue replicates was SD ≤ 18%
Any other information on results incl. tables
Table 1. Summary of results.
| Well ID | OD | Mean OD / disc (#) | Mean OD / product | Viability % | Mean viability % | SD viability | Conclusion |
Negative control | SPL 1 | 0.922 0.941 0.926 | 0.929 | 0.902 | 103.0 100.7 | 100.0 | 3.4 |
|
SPL 2 | 0.851 0.873 0.884 | 0.869 | ||||||
SPL 3 | 0.870 0.934 0.920 | 0.908 | ||||||
Positive control | SPL 4 | 0.018 0.016 0.018 | 0.017 | 0.016 | 1.9 1.8 | 1.8 | 0.1 | Irritant |
SPL 5 | 0.016 0.015 0.015 | 0.015 | ||||||
SPL 6 | 0.016 0.016 0.016 | 0.016 | ||||||
Test item PH- 21/0781 | SPL 7 | 0.969 0.996 0.917 | 0.960 | 0.862 | 106.4 87.8 | 95.5 | 9.7 |
|
SPL 8 | 0.861 0.836 0.803 | 0.833 | ||||||
SPL 9 | 0.824 0.773 0.781 | 0.792 | ||||||
Test item PH- 21/0781 NSMTT | SPL 10 | 0.007 0.008 0.008 | 0.007 | 0.007 | 0.8 0.7 | 0.7 | 0.1 | |
SPL 11 | 0.006 0.007 0.007 | 0.006 | ||||||
Test item PH- 21/0781 Corrected |
|
|
|
| 94.8 |
| Non irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Non-irritant to skin, no category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Under test conditions, the mean percent viability of the treated tissues was 94.8% versus 1.8% with the positive control item (5% SDS). Therefore, the test item is not irritant to the skin.
- Executive summary:
An in vitro skin irritation test was performed with the test item in a reconstructed human epidermis SkinEthic RHE® model, according to OECD TG 439, under GLP conditions.
Three epidermis units were treated with 16 mg test item for 42 minutes at room temperature. Exposure to the test item was terminated by rinsing with 25 x 1 mL of DPBS. The epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues with MTT, extracting the precipitated formazan crystals using isopropanol for 2 hours under gentle agitation in the dark, and measuring the concentration of formazan by determining the OD at 570 nm, just after dilution of the extracts 1:2 in isopropanol. Distilled water was used as a negative control and 5% SDS solution as positive control; two killed control tissue models were added to the study which underwent the entire testing procedure to generate a non-specific MTT reduction control.
Under test conditions, the mean percent viability of the treated tissues was 94.8% versus 1.8% with the positive control item (5% SDS). Therefore, the test item must be considered as non-irritant to skin.
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