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Diss Factsheets
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EC number: 942-403-2 | 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:
- 11 May - 01 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted similarly to OECD Guideline 431 with minor deviation: reference to historical data of the positive and negative controls not reported
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- reference to historical data of the positive and negative controls not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- ethanol water extract from husk of Chenopodium quinoa, Chenopodiaceae
- IUPAC Name:
- ethanol water extract from husk of Chenopodium quinoa, Chenopodiaceae
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material: MEXORYL SCK
- Physical state: Beige powder
- Analytical purity: saponines content (determined by HPLC assay) 55.8 % w/w
- Lot/batch No.: R0069579A 003 P 001
- Shelf life/Retest date: April 2011
- Storage condition of test material: Stored at room temperature and away from light and moisture
Constituent 1
Test animals
- Species:
- other: human skin
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg ± 2 mg applied onto the epidermis
- Concentration: Undiluted - Duration of treatment / exposure:
- Application and post-treatment incubation time: 15 minutes ± 0.5 minute treatment at room temperature and incubated for 42 h ± 1 h (37 °C, 5 % CO2, 95 % humidity).
- Observation period:
- - At the end of the 42 h post-treatment incubation period: MTT test was performed and plates were incubated for 3 hours to 3 hours and 15 minutes (37 °C, 5 % CO2, 95 % humidity).
- At the end of the MTT incubation and extraction period: The optical density (O.D.) was measured at 570 nm versus acidified isopropanol (blank). - Number of animals:
- Not applicable
- Details on study design:
- Preparation of the epidermis:
On Day 13, the kits were placed at room temperature protected from light. On Day 14, the color of the agar medium was checked. The epidermis were transferred onto 2 mL of the maintenance medium (at room temperature), and incubated for about 24 h (37 °C, 5 % CO2, 95 % humidity).
Negative and positive controls (reference substances) and raw material were tested in triplicate.
- Negative control: 10 µL of PBS.
- Positive control: 10 µL of 5 % aqueous solution of Sodium Dodecyl Sulfate
Results and discussion
In vivo
- Irritant / corrosive response data:
- See table 7.3.1/1
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: RESULTS SUMMARY: % VIABILITY AND IL 1α CONCENTRATIONS
RAW MATERIAL |
%viability |
IL-1α (pg/mL) |
||||||||
Run 1 |
Run 2 |
Run 3 |
Mean |
SD |
Run 1 |
Run 2 |
Run 3 |
Mean |
SD |
|
MEXORYL SCK (undiluted) |
99.5 |
86.6 |
98.1 |
94.7 |
7.1 |
6.7 |
13.6 |
16.6 |
12.3 |
5.1 |
Reconstructed epidermis batch numbers
Run 1: batch No: 10-EKIN-017
Run 2: batch No: 10-EKIN-018
Run 3: batch No: 10-EKIN-019
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, MEXORYL SCK tested undiluted is considered as potentially non-irritant.
- Executive summary:
An in vitro skin irritation study was performed similarly to the OECD Guideline 431 and in compliance with GLP, using the Episkin reconstituted skin model. Test item, MEXORYL SCK (10 mg ± 2 mg) was applied onto the epidermis. Application and post-treatment incubation time was 15 minutes ± 0.5 minute treatment at room temperature and 42 h ± 1 h (37 °C, 5 % CO2, 95 % humidity), respectively. Cell viability and IL-1α concentrations were determined. Negative (PBS) and positive (5 % aqueous solution of Sodium Dodecyl Sulfate) controls also included in this test.
RAW MATERIAL
%viability
IL-1α (pg/mL)
Run 1
Run 2
Run 3
Mean
SD
Run 1
Run 2
Run 3
Mean
SD
MEXORYL SCK
(undiluted)
99.5
86.6
98.1
94.7
7.1
6.7
13.6
16.6
12.3
5.1
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