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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:
- 22 Feb 2021 to ... July 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
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:
- adopted 26. Jun. 2020
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted 06. Jul. 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt Rheinland-Pfalz 15 May 2018
Test material
- Reference substance name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, manganese sodium salts
- Molecular formula:
- not applicable: UVCB
- IUPAC Name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, manganese sodium salts
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- commercially available EpiDermTM-Kit, procured by MatTek
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis.
- Details on animal used as source of test system:
- not applicable
- Justification for test system used:
- This in vitro study was performed in order to evaluate the potential of "manganese-EDDHA sodium salts" to evoke skin irritation in a Reconstructed human Epidermis (RhE) test method.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RhE) TISSUE
- Model used:
EpiDermTM-Kit, procured by MatTek
- Designation of the kit:
1) EPI-200-SIT
2) EPI-218_SIT
- Tissue batch number(s):
1) 34134
2) 34162
- Delivery date:
1) 2021 March 16
2) 2021 May 25
- Date of initiation of testing:
2021 March
- Date of experimantal completion
2021 March
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 35 minutes at 37 ± 1°C and 5.0 ± 1% CO2 and ≥ 95% relative humidity and 25 min at room temperature
- Temperature of post-treatment incubation (if applicable): 37 ± 1 °C and 5.0 ± 1% CO2 and ≥ 95% relative humidity
REMOVAL OF TEST MATERIAL AND CONTROLS
1 hour after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in 1-minute-intervals.
After rinsing thoroughly with DPBS, each tissue was blotted with sterile cellulose tissue and then transferred into a new 6-well-plate with fresh assay medium (0.9 mL). The surface of the inserts was then carefully dried with a sterile cotton tipped swab.
Then, the tissues were set in the incubator for 24 hours at 37 ± 1°C and 5.0 ± 1% CO2 and ≥ 95% relative humidity.
After incubation the tissues were removed from the incubator and shaken for 5 minutes (120 rpm). 0.9 mL assay medium were filled in the lower row of the 6-well-plate. Then the inserts were transferred into the lower row of the 6-well-plate and set into the incubator for 19 hours and 40 minutes in the main test and 18 hours in the additional test for post-incubation at 37 ± 1°C and 5.0 ± 1% CO2 and ≥ 95% relative humidity.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Microtiter plate photometer Anthos Reader 2010 Flexi (Anthos Microsysteme GmbH)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
Batch 34134
- Viability: MTT QC assay, 4 hours, n=3 -> OD=1.624 ± 0.135 (range 1 - 3 -> passed)
- Barrier function: ET50 assay (1 % Triton) -> ET50=4.84 h (range 4.77 - 8.72 h -> passed)
- Contamination: no contamination
Batch 34162
- Viability: MTT QC assay, 4 hours, n=3 -> OD=1.57 ± 0.047 (range 1 - 3 -> passed)
- Barrier function: ET50 assay (1 % Triton) -> ET50=6.28 h (range 4.77 - 8.72 h -> passed)
- Contamination: no contamination
NUMBER OF REPLICATE TISSUES:
3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues
- N. of replicates : 2
- Method of calculation used: Viability treated tissue (corrected) = Viability treated tissue (main test) – Viability treated tissue (additional test, no MTT assay)
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 irritating to skin if the viability after 60 minutes exposure is less than or equal to 50%
- The test substance is considered to be non-irritating to skin if the viability after 60 minutes exposure is greater than 50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
main test 26.3; 25.9; 26.3 mg
additional test 26.1; 25.9 mg
VEHICLE
no vehicle used
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL [“Dulbecco’s Phosphate Buffered Saline” (DPBS buffer without CaCl2 and without MgCl2)]
- Concentration (if solution): 100 %
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL [SDS-solution]
- Concentration (if solution): 5 % - Duration of treatment / exposure:
- 60 min
- Duration of post-treatment incubation (if applicable):
- 43 hours and 40 minutes in the main test and 42 hours in the additional test
- Number of replicates:
- 3 (main test), 2 (additional test)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 91.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 90.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 80.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 87.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
All validity criteria were met.
The values for negative control and for positive control were within the range of historical data of the test facility
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Manganese-EDDHA sodium salts is considered as not irritant to skin. After the treatment, the mean value of relative tissue viability was 87.3 %. This value is well 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. The 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.
- Executive summary:
One valid experiment was performed according to OECD Guideline 439 following GLP with three tissues and two independent MTT measurements. Three tissues of the human skin model EpiDermTM were treated with the test item for 60 minutes. The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm²; as indicated by the supplier). DPBS-buffer was used as negative control and 5% SDS solution was used as positive control. After treatment with the negative control, the mean absorbance value was within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.653. The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.8% (required: ≤ 20%). The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%). After the treatment with the test item, the mean value of relative tissue viability was 87.3%. This value is well above the threshold for skin irritation potential (50%). Thus, the test item Manganese-EDDHA sodium salts is considered as not irritant to skin. As the test item showed intense coloring in the pre-test, there was the risk to influence the photometric measurement and create a false negative result. Therefore, an additional test for intensely coloured test items was performed.The result of the valid additional test showed, that the test item colour did not critically influence the result of the study and no data correction is necessary.
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