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EC number: 951-773-4 | 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:
- 2020-11-24 - 2021-03-01
- 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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- By-product from Guanidinoacetic acid manufacturing
- EC Number:
- 951-773-4
- Molecular formula:
- - Hydantoic Acid Sodium salt: C3H5N2O3Na - Cyanoguanidine: C2H4N4 - Sodium acetate: C3H3O2Na - Glycine: C2H5NO2 - N,N'-Guanidinodiacetic acid: C5H9N3O4 - N,N-Guanidinodiacetic acid: C5H9N3O4 - Guanidinoacetic acid:C3H7N3O2 - Urea: CH4N2O - Water: H2O - Biguanidinoacetic acid: C4H10N6O2 - Sodium formate: CHO2Na - Glycylglycine: C4H8N2O3
- IUPAC Name:
- By-product from Guanidinoacetic acid manufacturing
- Test material form:
- solid
1
- Specific details on test material used for the study:
- 201009MA2 solid
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of
normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of
the species of interest and closely mimics the biochemical and physiological properties of the upper
parts of the human skin, i.e. the epidermis. - Vehicle:
- other: Dulbecco’s phosphate buffered saline (DPBS)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg + 25 µL DPBS
- Duration of treatment / exposure:
- 60 min
- 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. 59.2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The relative mean
tissue viability after 60 min of exposure and 42 h post-incubation was > 50%. The test item is therefore
classified as “non-irritant” in accordance with UN GHS “No Category”. - Executive summary:
In the present study the skin irritant potential of By-product from Guanidinoacetic acid manufacturing
was analysed. The EpiDerm™-Standard Model (EPI-200™), a reconstituted three-dimensional human
epidermis model, was used as a replacement for the Draize Skin Irritation Test (OECD TG 404, [7]) to
distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test
substances (“No Category”) which may be considered as non-irritant. Hereby, the test item was
applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity
measured by formazan production from MTT after a 60 min exposure and 42 h post-incubation period
and compared to those of the concurrent negative controls.
To check the non-specific MTT-reducing capability of the test item 25 mg of the test item was mixed
per 1 mL MTT medium and incubated for 60 min at 37 1 °C in the incubator. The mixture did not turn
blue/purple. Thus, the additional test with freeze-killed tissues and the quantitative corrections were
not necessary.
To check the colouring potential of the test item 25 mg of the test item was mixed per 300 μL aqua
dest. and/or per 300 μL isopropanol each in a transparent recipient and incubated at 37 ± 1°C for
60 min. The mixture showed no relevant colouring detected by unaided eye-assessment. Thus, the
additional test with viable tissues and the quantitative corrections were not necessary.
The test item showed no non-specific reduction of MTT and no relevant colouring potential after
mixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction of
possible false-negative results were necessary.
The test item showed no irritant effects. The mean relative tissue viability (% negative control) was
> 50% (59.2%) after 60 min treatment and 42 h post-incubation.
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