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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 September 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted and well described study in accordance with GLP and OECD Guideline 437 without any deviation.
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:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
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 / tissue source
- Species:
- other: bovine eye
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Eyes selection: from reception of eyes: detection of defects of the cornea, elimination of eyes presenting defects, elimination of the too big eyes, all stages were performed by avoiding touching corneas, in order not to damage them.
- Preservation of the corneas: eyes were placed in buffered Hanks medium enriched with antibiotics and preserved at 5 ± 3 °C for maximum duration of 24 h.
Test system
- Vehicle:
- other: distilled water
- Controls:
- other: negative control: 0.9 % w/v sodium chloride solution
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL ± 8 µL per cornea
- Concentration (if solution): Diluted to 20 % (w/w) in distilled water
- pH of the preparation : 5.5 - Duration of treatment / exposure:
- - Contact timepoint: 4 h ± 10 minutes at 32 ± 1 °C.
- Observation period (in vivo):
- - Corneal opacity was measured pre-treatment, post-treatment and post-incubation (after 4 h ± 10 minutes of incubation at 32 ± 1 °C).
- Application of Fluorescein (5 mg/mL) and corneal permeability was measured after 90 ± 5 min of incubation at 32 ± 1 °C. - Number of animals or in vitro replicates:
- Total: 9 corneas - 3 corneas/group for test item, negative and positive controls
- Details on study design:
- Details of test procedure: Eyes were placed in buffered Hanks medium enriched with antibiotics and preserved at 5 ± 3 °C for maximum duration of 24 h. Corneas were mounted in corneal holders and preincubated in nutritive medium in water-bath at 32 ± 1 °C for at least one hour. Before the treatment, opacity measurement was performed using an OP KIT opacitometer. The test item (750 µL ± 8 µL) was applied on each cornea and incubated for 4 h ± 10 minutes at 32 ± 1 °C. At the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed three times with nutritive medium containing phenol red at 32 ± 1 °C before a final rinse with nutritive medium. The anterior chamber was refilled with nutritive medium. Measurement of the opacity OPT2 (OPT “2 hours”) of each cornea vs an empty holder (containing nutritive medium only). Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of fluorescein solution (5 mg/mL) and the holders were incubated at 32 ± 1 °C for 90 ± 5 minutes. After incubation the medium in the posterior chamber of each holder was decanted and retained. 360 µL of medium representing each cornea was applied to a designated well on a 96-well plate and the optical density at 490 nm (OD490) was measured.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In Vitro Irritancy Score (IVIS)
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 82.2
- Reversibility:
- not reversible
- Remarks on result:
- other: score: 82.2 ± 4.9
- Irritant / corrosive response data:
- - In Vitro Irritancy Score (IVIS) were 82.2 ± 4.9 and 193.0 ± 2.4 for test item and positive controls, respectively.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: In vitro eye irritation – results
Holder No |
Treatment |
OPT0 |
OPT2 |
OPT2 – OPT0 |
Corrected opacity |
DO |
Corrected OD |
Score OPc + 150DOc |
97 |
Negative control |
0 |
0 |
0 |
|
0.070 |
|
|
440 |
3 |
3 |
0 |
|
0.091 |
|
|
|
86 |
0 |
0 |
0 |
|
0.071 |
|
|
|
Comments: Nil |
Mean |
0.0 |
0.077 |
|
||||
SD |
0.0 |
0.012 |
|
|||||
29 |
Imidazole 20 % |
1 |
146 |
145 |
145.0 |
3.256 |
3.179 |
192.7 |
300 |
0 |
147 |
147 |
147.0 |
3.312 |
3.235 |
195.5 |
|
210 |
0 |
142 |
142 |
142.0 |
3.332 |
3.255 |
190.8 |
|
Comments: Detachment of epithelium and edema |
Mean |
144.7 |
3.223 |
193.0 |
||||
SD |
2.5 |
0.039 |
2.4 |
|||||
2 |
MEXORYL SCK |
2 |
27 |
25 |
25.0 |
4.092 |
4.015 |
85.2 |
12 |
I.E.C: 101382 0000B455 |
4 |
24 |
20 |
20.0 |
3.848 |
3.771 |
76.6 |
58 |
Diluted to 20 % |
0 |
28 |
28 |
28.0 |
3.866 |
3.779 |
84.7 |
Comments: Detachment of epithelium and edema |
Mean |
24.3 |
3.855 |
82.2 |
||||
SD |
4.0 |
0.139 |
4.9 |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, MEXORYL SCK applied diluted to 20 % (w/w) in distilled water, is classified as corrosive or severe irritant for the isolated bovine cornea, after 4 h of contact.
- Executive summary:
In an in vitro eye irritation study performed according to the OECD Guideline 437 and in compliance with GLP, test item, MEXORYL SCK diluted to 20 % (w/w) in distilled water (750 µL ± 8 µL per cornea) was applied to isolated bovine corneas mounted in corneal holders, and incubated for 4 h ± 10 minutes at 32 ± 1 °C. Three corneas were used for each treated series (test item; negative control; positive control: Imidazole 20 %). The two endpoints, corneal opacity and corneal permeability were measured and In Vitro Irritancy Score (IVIS) was calculated.
In Vitro Irritancy Score (IVIS) were 82.2 ± 4.9 and 193.0 ± 2.4 for test item and positive controls, respectively.
Under the test conditions, MEXORYL SCK applied diluted to 20 % (w/w) in distilled water, is classified as corrosive or severe irritant for the isolated bovine cornea, after 4 h of contact.
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