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EC number: 258-887-7 | CAS number: 53956-04-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ammonium glycyrrhizate
- EC Number:
- 258-887-7
- EC Name:
- Ammonium glycyrrhizate
- Cas Number:
- 53956-04-0
- Molecular formula:
- C42H65NO16
- IUPAC Name:
- ammonium glycyrrhizate
1
In vitro test system
- Test system:
- isolated skin discs
- Source species:
- human
- Cell type:
- other: Reconstructed Human Epidermis
- Cell source:
- other: foreskin
- Source strain:
- other: not applicable
- Vehicle:
- water
- Remarks:
- distilled
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Episkin SA, RHE
- Tissue batch number(s): 17-RHE-088
- Production date: not specified
- Shipping date: not specified
- Delivery date: not specified
- Date of initiation of testing: 23/08/2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 42 minutes after the test item application, the human epidermis were washed with 25 x 1 mL of DPBS (Dutscher - Batch No. 9130617). The rinsed tissues were checked for any coloration and noted to be
whitish, comparable to negative control tissues. They were incubated for a 42 hours post-treatment incubation-period in fresh medium at 37°C, 5% CO2.
- Observable damage in the tissue due to washing: none
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: ELx800
- Wavelength: 570 nm
- Filter: No filter was used for the measurement of OD
- Linear OD range of spectrophotometer: between 0 and 2.0
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE (from certificate of analysis)
- Viability: O.D. = 1.4
- Barrier function: 4.3 h
- Morphology: absence of significant histological abnormalities
- Contamination: the product was prepared and packaged using aseptic techniques
- Reproducibility: not specified - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 mg of test item on 0.50 cm2 human skin model equal to 32 mg/cm2
The test item was applied, as supplied, during 42 minutes at room temperature at the dose of 16 mg to the epidermal surface of 3 living Reconstructed Human epidermis previously moistened with 10 µL of distilled water.
42 minutes after the test item application, the human epidermis were washed with 25 x 1 mL of DPBS (Dutscher - Batch No. 9130617). The rinsed tissues were checked for any coloration and noted to be whitish, comparable to negative control tissues.
NEGATIVE CONTROL - DPBS
- Amount(s) applied (volume or weight): 16 µL
- Concentration (if solution):
POSITIVE CONTROL - SDS
- Amount(s) applied (volume or weight): 16 µL
- Concentration (if solution): 0.5 g in 10 mL equal to 50 g/L - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- They were incubated for a 42 hours post-treatment incubation-period in fresh medium at 37°C, 5% CO2. Then, the epidermis were put in contact with the MTT solution.
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean viability based on 3 replicates
- Value:
- ca. 80.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- viability 1.2%
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction: The direct interaction of MTT with the test item was checked by adding 16 mg of the test item to 300 µL of solution of MTT at 1 mg/mL. A cloudy yellow solution was observed after 3 hours of incubation between 36.2°C and 37.4°C, 5% CO2. Therefore, there is no direct interaction between the test item and MTT.
- Coloration potential and spectral analysis of the test item:
In water, the coloration potential of the test item in water was checked by adding approximatively 16 mg of the test item to 300 µL of distilled water. A colorless solution with the test item at the bottom of the well was obtained after 3 hours of incubation between 36.2°C and 37.4°C, 5% CO2.
In isopropanol, the coloration potential of the test item in isopropanol was checked by adding approximatively 16 mg of the test item to 1.5 mL of isopropanol. A colorless solution was obtained after 2 hours of incubation at room temperature.
No significant coloration appeared. Therefore the test item will not interfere with the MTT assay.
DEMONSTRATION OF TECHNICAL PROFICIENCY: a summary of proficiency chemicals testing has been provided in appendix of the report between 2009 and 2016, results observed are in line with those waited.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes; in line with historical control
- Acceptance criteria met for positive control: yes; in line with historical control
- Acceptance criteria met for variability between replicate measurements: yes; SD = 4.5 below 18
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under test conditions of OECD 439 (guideline of 28 july 2015) GLP study, test item is not considered as skin irritant with respect to CLP regulation.
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