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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Sep - 14 Oct 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted Jul 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
Test material
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of tetra (potassium and sodium) (2R,3R)-2-hydroxy-3-(phosphonatooxy)succinate and potassium sodium (2S,3S)-2-hydroxy-3-(phosphonatooxy)succinate
- Physical state: white to yellowish powder of crystalline appearance
- Lot/batch No.: 010-2065
- Expiration date of the lot/batch: 16 Sep 2019
- Storage condition of test material: at temperatures < 40 °C, above fresh phosphorous pentoxide or in air tight sealed containers, reduce exposure to air to a minimum
- Other: very hygroscopic substance, pH = 9.45 (1% in solution)
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: EpiDermTM; reconstructed three-dimensional human epidermis
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: MatTek In Vitro Life Science Laboaratories, s.r.o, Bratislava, Slovak Republic
TEST METHOD
EPI-200-SCT: The model represents a reconstructed three-dimensional skin model based on normal human-derived epidermal keratinocytes which have been cultured to form a multilayered epidermis including basal, spinous and granular layers, and a multi-layered stratum corneum. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers which is determined through a decrease in cell viability as determined by MTT reduction assay. Histological examination to demonstrate appropriate morphology of the tissue was performed and the barrier properties of the tissue were confirmed by the manufacturer. The tissue was shown by the manufacturer to be free of contamination with virus, bacteria (including myoplasma) and fungi. The ET50 was shown to fall within the predefined range.
ADAPTATION TO CELL CULTURE CONDITIONS
EpiDerm tissue samples were conditioned by pre-incubation (1 hour) in Maintenance Medium for release of transport stress-related compounds and debris in the incubator (37 °C, 5% CO₂, 95% humidity). After pre-incubation the tissue was transferred to fresh Maintenance Medium and topically exposed with the test chemicals for 3 min and 60 min, respectively. Two tissue samples were used per treatment, negative and positive controls and exposure time (12 in total). After exposure, the tissue was rinsed, blotted and assay medium was replaced by MTT assay medium 2 (final concentration: 1 mg MTT (3-[4,5-Dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide, Thiazolyl blue)/mL medium). After a 3-h incubation, the tissue was washed with Dulbecco's phosphate buffered saline (D-PBS), blotted and the blue formazan salt was extracted with propanol-2. The optical density of the formazan extract was determined spectrophotometrically at 540 nm and cell viability was calculated for each tissue as % of the mean of the negative control tissues. Skin corrosivity potential of the test materials was classified according to the remaining cell viability obtained after 3 minutes or 1 hour exposure with the test chemical.
INCUBATION CONDITIONS (INCUBATOR)
- Temperature (°C): 37
- CO₂ gas concentration (%): 5
- Humidity: 95%
Test system
- Type of coverage:
- other: in vitro cell system
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with 50 μL sterile deionised water served as negative controls, positive controls were exposed to 50 μL 8N KOH
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg - Duration of treatment / exposure:
- 3 and 60 min
- Observation period:
- Not applicable
- Number of animals:
- Not applicable. The test was performed in duplicates for each test or control group and treatment period (3 and 60 min).
- Details on study design:
- TEST SITE
- Area of exposure: 0.63 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period the test substance was carefully washed from the skin surface with Dulbecco's phosphate buffered saline
- Time after start of exposure: 3 and 60 min
CELL VIABILITY MEASUREMENTS
MTT reduction assays were performed to determine the cell viability. Tissue samples were incubated in 1 mg/mL prewarmed MTT solution for 3 h at 37 °C, 95% humidity and 5% CO₂. The precipitated blue formazan product was extracted using the solvent propanol-2, and the concentration of the formazan was measured by determining the optical density (OD) at a wavelength of 540 nm in a spectrophotometer. Cell viability measurements were carried out at the end of the exposure period (1st period: 3 min; 2nd period: 60 min). The measurements were made for each of the two tissues in triplicate.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: cell viability
- Basis:
- other: mean value of negative controls (distilled water)
- Time point:
- other: 3 min
- Score:
- 100
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of the positive controls (8 N KOH)
- Time point:
- other: 3 min
- Score:
- 11.3
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of test item (undiluted)
- Time point:
- other: 3 min
- Score:
- 102.4
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: cell viability
- Basis:
- other: mean value of negative controls (distilled water)
- Time point:
- other: 60 min
- Score:
- 100
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of test item (undiluted)
- Time point:
- other: 60 min
- Score:
- 66.2
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of the positive controls (8 N KOH)
- Time point:
- other: 60 min
- Score:
- 8.1
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The mean viability of cells exposed to the test item was 102.4% after a 3 min exposure period and 66.2% after a 60 min exposure period, compared with the negative controls (100%). The optical density for the 3-min negative control, 3-min treated tissue samples and 3-min positive control was 1.747 ± 0.091, 1.789 ± 0.046 and 0.198 ± 0.024, respectively. The optical density for the 60-min negative control, 60-min treated tissue samples and 60-min positive control was 2.072 ± 0.255, 1.372 ± 0.044 and 0.168 ± 0.007, respectively.
The 3-min and the 60-min exposure values were above the cut-off limit for cell viability values (> 50% and > 15%, respectively) that distinguish corrosive from non-corrosive test substances. The test substance was non-corrosive in this skin model and is therefore predicted to be non-corrosive to human skin. The negative and positive controls were shown to be valid and fell within the historical control data range.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Bár az ECHA sok anyagot az ön nyelvén is rendelkezésre bocsát az interneten, az oldal egy része csak angolul érhető el. Bővebben az ECHA többnyelvűségre irányuló gyakorlatáról.
Üdvözöljük az ECHA weboldalán! Az oldal az Internet Explorer 7 (és korábbi verziók) alatt nem teljes mértékben támogatott. Kérjük, frissítse Internet Explorer böngészőjét egy újabb verzióra!
Ez a weboldal cookie-kat használ a legjobb felhasználói élmény biztosítása érdekében.
További információ a cookie-k használatáról.