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Diss Factsheets
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EC number: 236-860-0 | CAS number: 13518-93-9
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-04-05 to 2017-12-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- 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:
- July 28, 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz
Test material
- Reference substance name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)
- EC Number:
- 236-860-0
- EC Name:
- Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)
- Cas Number:
- 13518-93-9
- Molecular formula:
- C3H6N6.1/2H4O7P2
- IUPAC Name:
- diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)
- 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: human donors
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: reconstituted three-dimensional human skin model EpiDerm (MatTek)
- Tissue batch number(s): 25829
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: At the end of the exposure period, the test item was carefully washed from the skin surface with Dulbecco's phosphate buffered saline.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: yes
- Wavelength: 540 nm
- Filter: no
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 1.857 ± 0.107
- Barrier function: 5.4 h
- Contamination: Screened for HIV-1, hepatits B and C, bacteria, yeast, and other fungi. No contaminates were detected.
NUMBER OF REPLICATE TISSUES: triplicate
PREDICTION MODEL / DECISION CRITERIA
The irritant potential was predicted from the relative mean tissue viabilities compared to the negative control. If the mean relative tissue viability is > 50% the test material is not considered an irritant. If the mean relative tissue viability is ≤ 50%, the test material is considered an irritant.
The test meets acceptance criteria if:
- mean absolute OD570 of the three negative control tissues is ≥ 1.0 and ≤ 2.5
- mean relative tissue viability of the three positive control tissues is ≤ 20%
- standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is ≤ 18%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg
- Concentration: 25 mg test item were mixed with 300 μL sterile deionised water
NEGATIVE CONTROL
- Amount(s) applied: 30 μL
POSITIVE CONTROL
- Amount(s) applied: 30 μL - Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 111
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
The standard deviation determined for all triplicates was below the limit of acceptance of 18 %. Hence, all acceptance criteria required were fulfilled.
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
Any other information on results incl. tables
Table 1. Summary of Results
|
Optical density [OD540] mean tissue (n = 3) |
Mean Viability (n = 3) [%] |
CV [%] |
Dimelamine pyrophosphate |
1.550 |
111.0 |
1.2 |
D-PBS (negative control) |
1.396 |
100.0 |
7.6 |
5% SDS (positive control) |
0.092 |
6.5 |
10.9 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification is required according to Regulations (EC) No 1272/2008.
- Conclusions:
- In an in vitro skin irritation human skin model test (EpiSkin) according to OECD guideline 439 and in compliance with GLP, a cell viability of 111% was measured when compared to the untreated control. Therefore, the test item should not be classified.
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