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Diss Factsheets
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EC number: 943-893-0 | 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:
- 23 Nov - 01 Dec 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2017
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 Jul 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Test material
- Reference substance name:
- 2-{3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl}ethyl hydrogen phosphate
- EC Number:
- 600-039-9
- Cas Number:
- 10023-48-0
- Molecular formula:
- C12H17N4O4PS
- IUPAC Name:
- 2-{3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl}ethyl hydrogen phosphate
- 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: SkinEthic™ RHE-model
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic™ RHE-model (Episkin/SkinEthic Laboratories, Lyon, France)
- Tissue batch number(s): 16-RHE-122
- Expiration date: 28 Nov 2016
- Date of initiation of testing: 23 Nov 2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: At room temperature for 42 ± 1 min
- Temperature of post-treatment incubation: At 37 °C for 42 ± 1 h
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Test material and controls were removed immediately by gently rinsing with a minimum volume of 25 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the tissue inserts and blotting the bottom of the tissue inserts with blotting paper.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h ± 5 min
- Spectrophotometer: Microplate reader (ELx800, BioTek Instruments GmbH, Bad Friedrichshall, Germany)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the SkinEthic™ RHE-model was assessed by undertaking an MTT cell viability test.
- Barrier function: According to the Quality Control Data, the barrier function was assessed by determination of the exposure time required to reduce tissue viability by 50% (ET-50) using 1% Triton X-100. The ET-50 value was determined to be 5.2 h.
- Histological observations (HES stained vertical paraffin sections): 6 cell layers, absence of significant histological abnormalities.
NUMBER OF REPLICATE TISSUES: Triplicate tissues; from each tissue, 3 absorbance measurements after MTT incubation were performed
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues: The test item has the ability to directly reduce MTT. To evaluate the extent of non-specific interaction, three killed tissues were treated with the test item and the negative control, respectively. The treatment and MTT assay of the killed tissues was similar to the handling of the living tissues.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3 independent tissues
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to beirritant to skin if the viability is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 16 mg
- Other: Before application of the test substance, 10 µL of deionised water was spread to the epidermis surface to improve the contact between the test substance and the epidermis.
NEGATIVE CONTROL
- Amount(s) applied: 16 µL
POSITIVE CONTROL
- Amount(s) applied: 16 µL
- Concentration: 5% aqueous solution of sodium dodecyl sulfate - Duration of treatment / exposure:
- 42 ± 1 min
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h
- Number of replicates:
- Triplicate tissues; from each tissue, 3 absorbance measurements after MTT incubation were performed
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean of three tissues
- Value:
- 90.39
- 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:
- - OTHER EFFECTS:
- Direct-MTT reduction: For correct interpretations of results it is necessary to assess the ability of the test substance to directly reduce MTT. This pre-test for direct MTT-reducing capacity of the test item did result in blue color, i.e. the test item is a direct MTT reducer.
- Colour interference with MTT: In the pre-test medium coloration by the test item was observed, but no tissues were stained during the study. Therefore, no additional tissues for color control were treated.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The negative control OD (2.450, 2.313 and 2.318) was in the range of ≥ 0.8 and ≤ 3.0 for all three tissues. The mean OD was 2.318 which is higher than the historically established threshold of 1.436. As the negative control result fell within the range defined in the acceptance criteria, the result is considered to be valid.
- Acceptance criteria met for positive control: Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control to 1.13% which is lower than the historically established threshold of 3.12%.
- Acceptance criteria met for variability between replicate measurements: The Standard deviations between the three tissue replicates of the negative control and the positive control were 5.57% and 2.95%, respectively, which is ≤ 18%.
Any other information on results incl. tables
Table 1: Summary or results
Tissue 1 | Tissue 2 | Tissue 3 | Mean | Standard Deviation | |||||
Group | OD | Viability (%) | OD | Viability (%) | OD | Viability (%) | OD | Viability (%) | Viability (%) |
Negative control | 2.450 | 105.68 | 2.192 | 94.55 | 2.313 | 99.77 | 2.318 | 100.00 | 5.57 |
Positive control | 0.027 | 1.16 | 0.026 | 1.11 | 0.026 | 1.11 | 0.026 | 1.13 | 2.95 |
Test substance | 2.110* | 86.12 | 2.117* | 96.58 | 2.046* | 88.46 | 2.091 | 90.39 | 6.07 |
* corrected optical density after metabolic conversion
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the RHE test method the test substance did not show irritant properties.
CLP: not classified
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