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Diss Factsheets
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EC number: 938-980-5 | 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:
- May 24 - June 03, 2013
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Qualifier:
- according to guideline
- Guideline:
- other: L’Oréal Standard Operating Procedure: “EpiSkin™ Skin Irritation Test Method“; - ECVAM Skin Irritation Validation Study - Validation of the EpiSkin™ Test Method15 min - 42 hours for the Prediction of Acute Skin Irritation of Chemicals. Version 1.8, 02-2009
- Qualifier:
- according to guideline
- Guideline:
- other: ECVAM Performance Standards for in vitro Skin Irritation Test Methods based on Reconstructed human Epidermis (RhE). Updated Version 24-Aug-2009
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 10993-10, Annex D: 2010, “Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization”
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration
- EC Number:
- 938-980-5
- IUPAC Name:
- Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Soybean (Glycine max) dry purified extract
Batch No.: 30432/M1
Physical State: powder
Colour: yellow to light brown
Purity: 100%
Storage Conditions: at room temperature
Constituent 1
Test system
- Details on study design:
- Cytotoxicity is expessed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 15 min exposure and 42 h post incubation period and compared to those of the concurrent negative controls.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: skin irritant potential
- Remarks on result:
- other:
- Remarks:
- Remarks: no irritant effects. (migrated information)
Any other information on results incl. tables
Pre-Experiments
The mixture of 10 mg test item per 2 mL MTT medium showed reduction of MTT compared to the solvent. The mixture turned blue/purple. For quantitative correction of results, the part of absorption due to the non specific reduction of MTT (NSMTT) was determined by using killed tissues (4). Therefore, three tissues were treated with the test item (KT) and with PBS (KU), respectively. NSMTT was calculated relative to the negative control of living tissues (NK) according to the following formula:
NSMTT = [(ODKT - ODKU)/ODNK] * 100
Mean ODKT = 0.130
Mean ODKU = 0.150
Mean ODNK = 0.788
Since the calculated NSMTT was < 0% (-2.5%) the true MTT metabolic conversion (TODTT) of the test item treated living tissues (TM) was not calculated. The mixture of 10 mg of the test item per 90 μl aqua dest. showed no relevant colouring detectable by unaided eye-assessment.
Experiment
Name |
NegativeControl |
PositiveControl |
TestItem |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 a |
3 |
absoluteOD550 |
0.798 |
0.832 |
0.885 |
0.218 |
0.330 |
0.247 |
0.831 |
0.467 |
0.865 |
0.761 |
0.842 |
0.869 |
0.213 |
0.333 |
0.242 |
0.841 |
0.455 |
0.840 |
|
OD550(blank- corrected) |
0.755 |
0.788 |
0.842 |
0.175 |
0.287 |
0.203 |
0.787 |
|
0.821 |
0.718 |
0.798 |
0.825 |
0.169 |
0.290 |
0.198 |
0.798 |
|
0.797 |
|
meanOD550oftheduplicates(blank- corrected) |
0.736 |
0.793 |
0.833 |
0.172 |
0.288 |
0.201 |
0.792 |
|
0.809 |
totalmeanOD550of3replicatetissues(blank- corrected)
|
0.788* |
0.220 |
0.801 |
||||||
SDOD550 |
0.046 |
0.054 |
0.014 |
||||||
relativetissue viabilities[%] |
93.5 |
100.7 |
105.8 |
21.8 |
36.6 |
25.5 |
100.6 |
|
102.7 |
mean relative tissue viability [%] |
100.0 |
28.0** |
101.7 |
||||||
SDtissueviability[%]*** |
6.2 |
7.7 |
1.5 |
||||||
CV[%viability] |
6.2 |
27.5 |
1.5 |
a Tissue 2 was classified as Outlier acc. to Nalimov, Grubbs and Dixon and not used for evaluation * Corrected mean OD550 of the negative control corresponds to 100% absolute tissue viability. ** Mean relative tissue viability of the three positive control tissues is <= 40%. *** The standard deviation (SD) obtained from the three concurrently tested tissues is < 18%
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item showed no irritant effects. The relative mean tissue viability after 15 min of exposure and 42 h post incubation was >50%. The test item is therefore classified as “non-irritant”.
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