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Diss Factsheets
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EC number: 943-693-3 | 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Jan - Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (from the competent authority) Landesamt für Umwelt Rheinland-Pfalz
Test material
- Reference substance name:
- Reaction mass of diammonium (2R,3R)-2,3-dihydroxybutanedioate and diammonium bis[(2R,3R)-2,3-dioxidobutanedioato]diantimonate(2-)
- EC Number:
- 943-693-3
- IUPAC Name:
- Reaction mass of diammonium (2R,3R)-2,3-dihydroxybutanedioate and diammonium bis[(2R,3R)-2,3-dioxidobutanedioato]diantimonate(2-)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 170492F01
- Expiration date of the Batch: 22 Jun 2019
- Purity: 100.0 area-% (HPLC fingerprint)
- Content:
21.4 g/100 g Test Item
23.5 g/100 g (NH4)2C4H4O6
30 g/100 g Tartrate
6.7 g/100 g Ammonium
9.1 g/100 g Antimony
53.5 g/100 g Water
- pH value: ca. 9 (undiluted test substance)
- Physical state / color: Liquid / colorless to yellowish, clear
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
FORM AS APPLIED IN THE TEST: undiluted liquid test substance
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPI-200
- Tissue Lot-number: 25882
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: two
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Incubation time: 3 h
- Spectrophotometer: Sunrise Absorbance Reader
- Wavelength: 570 nm
- Filter: measurement without reference filter
NUMBER OF REPLICATE TISSUES: 2
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µL - Duration of treatment / exposure:
- 3 min and 1 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure period
- Value:
- 85.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h exposure period
- Value:
- 79.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Exposure period 3 min: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
Test substance indetification |
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
NC |
Mean OD570 |
1.789 |
1.779 |
1.784 |
|
|
Viability [% of NC] |
100.3 |
99.7 |
100.0 |
0.4 |
0.4 |
|
Test substance |
Mean OD570 |
1.516 |
1.534 |
1.525 |
|
|
Viability [% of NC] |
85.0 |
86.0 |
85.5 |
0.7 |
0.8 |
|
PC |
Mean OD570 |
0.179 |
0.185 |
0.182 |
|
|
Viability [% of NC] |
10.0 |
10.4 |
10.2 |
0.2 |
2.3 |
NC: negative control
PC: positive control
SD: standard deviation
CV: coefficient of variation
Table 2: Exposure period 1 h: Individual and mean OD570 values, individual and mean viability values, standard deviations and coefficient of variation
Test substance indetification |
|
Tissue 1 |
Tissue 2 |
Mean |
SD |
CV [%] |
NC |
Mean OD570 |
1.479 |
1.668 |
1.574 |
|
|
Viability [% of NC] |
94.0 |
106.0 |
100.0 |
8.5 |
8.5 |
|
Test substance |
Mean OD570 |
1.200 |
1.294 |
1.247 |
|
|
Viability [% of NC] |
76.2 |
82.3 |
79.3 |
4.2 |
5.4 |
|
PC |
Mean OD570 |
0.065 |
0.089 |
0.077 |
|
|
Viability [% of NC] |
4.1 |
5.7 |
4.9 |
1.1 |
22.5 |
NC: negative control
PC: positive control
SD: standard deviation
CV: coefficient of variation
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No prediction can be made for skin corrosion according to GHS criteria based on the results of this in vitro study alone.
- Executive summary:
The potential of the test substance to cause dermal corrosion was assessed by a single topical application of 50 µL undiluted test substance to a reconstructed three-dimensional human epidermis modell (EpiDerm).
Two EpiDerm tissues were incubated with the test substance for 3 minutes and 1 hour, each. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure / post-incubation by using a colorimetric test. The reduction of mitochondrial tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the epidermal tissues treated with the test substance is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.
The test substance is not able to reduce MTT directly.
The relative mean viability of the tissues treated with the test substance determined after an exposure period of 3 minutes was 85.5 %, and it was 79.3 % after an exposure period of 1 hour.
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