Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye 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 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- 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
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The 0.60 cm2 Reconstructed human Cornea-like Epithelia were received on 17 october 2017. The same day, the tissues in their well shipping container were equilibrated at room temperature for 15 minutes. Then, the inserts (filter + epithelium) were gently removed from the agarose while avoiding leaving agarose on the polycarbonate filyer. They were places in 6 wells culture plate with which had been previously filled with 1 mL of 37°C pre-warmed assay medium and incubated during 19 hours and 20 minutes at standard culture conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 mg
- Duration of treatment / exposure:
- 6 hours
- Duration of post- treatment incubation (in vitro):
- 18 hours and 15 minutes
- Number of animals or in vitro replicates:
- 2 replicates (RhCE)
- Details on study design:
- The test item was applied on a nylon mesh at an approximate dose of 50mg to the entire surface of 2 living RhCE tissues replicate during 6 hours at standard culture conditions.
In the same experimental conditions, a positive control (Methyl acetate) and a negative control (distilled water) were carried out. The controls were applied, as supplied, at the dose of 50µL, to the surface of 2 RhCE tissue replicates during 6 hours at standard culture conditions.
After the treatment, the test item and control substances were carefully washed from the RhCE tissues by extensive rinsing with Ca2+ Mg2+ Free-DPBS. The rinsed tissues were checked for any coloration and noted to be of comparable colour with the negative control treated tissues (whitish). The rinsing step was followed by a 25-minutes-post-exposure immersion period at room temperature in 5mL of fresh medium to remove any test item absorbed into the tissue.
The RhCE constructs were then incubated for an 18 hours and 15 minutes post-exposure incubation at standard culture conditions in 1mL of fresh medium at 37 °C, 5% CO2.
Viability measurements are performed immediately after the post-exposure incubation period of the rinsed tissues in fresh medium. This period allows both for recovery from weak cytotoxic effects ad appearance of clear cytotoxic effects. The RhCE tissue viability was measured by enzymatic covnersion of the vital dye MTT by the viable cells of the tissue into a blue MTT formazan salt that is quantitatively measured after extraction from tissues. The RhCE constructs were places in 300µL of a MTT solution at 1.0 mg/ml for 3 hours and 55 minutes at standard culture conditions. The precipitated blue formazan products was then extracted from the tissues by placing each insert in 2mL of isopropanol during 2 hours and 08 minutes at room temperature in the dark.
The concentration of formazan was measured by determining the optical density at 570 nm, just after dilution of the extraction in isopropanol (1:2)
The optical density was measured in triplicate samples of formazan extracts. The measured optical density are proportional to the number of living cells. The measurment was performed using the ELx800 absorbance microplate reader.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Viability %
- Value:
- 12.32
- Negative controls validity:
- valid
- Remarks:
- 100.00%
- Positive controls validity:
- valid
- Remarks:
- 19.83%
Applicant's summary and conclusion
- Interpretation of results:
- other: Based on a part of integrated approach, these results support a classification in Category 2 or Category 1 of GHS.
- Conclusions:
- Based on OECD 492 (2015), GLP study, results are considered scientifically valid to be used as part of an integrated approach to support a classification in Category 2 or Category 1 according to GHS and CLP regulation.
Refer to endpoint summary for final conclusion.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.