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EC number: 241-659-6 | CAS number: 17675-60-4
- 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:
- 08-05-2017 to 03-07-2017
- 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:
- OECD Guideline for the Testing of Chemicals No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amidinourea phosphate
- EC Number:
- 241-659-6
- EC Name:
- Amidinourea phosphate
- Cas Number:
- 17675-60-4
- Molecular formula:
- C2H6N4O.xH3O4P
- IUPAC Name:
- diaminomethylideneurea;phosphoric acid
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 16VL8189
Expiry Date: 03 August 2017
Storage Conditions: room temperature, protected from light
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm™ reconstructed human epidermis model (MatTek)
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM, a reconstituted three-dimensional human epidermis model.
- Source strain:
- not specified
- Details on animal used as source of test system:
- EpiDerm™ reconstructed human epidermis model (MatTek)
- Justification for test system used:
- This test method is able to detect chemicals that cause skin irritation, i.e. produce reversible damage to the skin and allows for hazard identification in accordance with UN GHS “Category 2”. Depending on the regulatory framework it can also be used to identify non-classified chemicals.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell ). The EpiDerm epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
Preparation and Application of the Test Item
25 μL of sterile DPBS was applied to the epidermal surface in order to improve the contact between the powder and the epidermis. Afterwards, 25 mg (39 mg/cm2) of the test item was applied directly atop the EpiDerm tissue using an application spoon avoiding compression of the test item. The test item was spread to match size of the tissue by gently shaking the inserts or by using a bulbheaded Pasteur pipette.
Controls
Controls were set up in parallel to the test item in order to confirm the validity of the test.
Negative Control
Dulbecco’s phosphate buffered saline (DPBS; Gibco, Cat. No. 14040-091, Lot No.: 1838067).
Positive Control
5% sodium dodecyl sulfate in H2O (TC-SDS-5%; Applichem CAS No.: 151-21-3, Lot No.: 40015277)
Dose Groups
1. Negative control 30 μL DPBS
2. Positive control 30 μL 5% SDS solution
3. Test Item 25 mg + 25 μL DPBS
The test was performed on a total of 3 tissues per dose group. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg (39 mg/cm2)
- Duration of treatment / exposure:
- Pre-incubation: 18 ± 3 h.
After dosing: 35 ± 1 min.
Post-incubation: 24 ± 2 h. Following this the tissues were transferred to new wells containing 0.9 mL fresh assay medium and incubated for an additional 18 ± 2 h. - Duration of post-treatment incubation (if applicable):
- See above
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: cytotoxic effects via MTT reduction assay.
- 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:
- Within experiment quality criteria met.
Any other information on results incl. tables
Results of the Test Item GUP
* Blank-corrected mean OD570nm of the negative control corresponds to 100% absolute tissue viability. ** Mean relative tissue viability of the three positive control tissues is < 20%. *** Standard deviation (SD) obtained from the three concurrently tested tissues is < 18% NK negative control PC positive control
|
Quality Criteria
|
Value |
Cut off |
pass/fail |
Mean Absolute OD570nmNK |
1.976 |
0.8 ± NK ± 2.8 |
pass |
Relative Viability [%] PC |
4.7 |
± 20% |
pass |
SD Viability [%] |
0.2 -9.5 |
± 18% |
pass |
NK negative control
PC positive control
Historical Data
|
Mean OD570±30nm NK |
Mean Relative Viability [%] PC |
SD Viability [%] |
Mean |
1.831 |
3.9 |
4.4 |
SD |
0.357 |
1.9 |
5.1 |
n |
27 |
27 |
88 |
Historical data were generated from 2009 to 2016.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item showed no irritant effects.
- Executive summary:
The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm (MatTek) comprising a reconstructed epidermis with a functional stratum corneum. In the present study GUP was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS. The test item showed no irritant effects. The mean relative tissue viability (% negative control) was > 50% (94.2%) after 60 min treatment and 42 h post-incubation. The controls confirmed the validity of the study.
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