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EC number: 223-264-0 | CAS number: 3792-50-5
- 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
Endpoint summary
Administrative data
Description of key information
Skin:
In an in vitro skin corrosion test (reconstructed human epidermis model, RHE) according to OECD Guideline 431, a cell viability of 88.5 % after 3 min incubation and 91.77 % after 1 h incubation was determined (reference 7.3.1 -1). Thus, the test substance is not to be considered to be classified as skin corrosive.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-12-05 to 2017-02-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The reconstructed human epidermis model in vitro method is an accepted in vitro method to replace animal testing. The human skin RHE™ model closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The SkinEthic™ RHE-model RHE/S/17 from Episkin/SkinEthic Laboratories, Lyon, France
- Tissue batch number: 16-RHE-130
- Date of initiation of testing: 2016-12-14
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: gently rinsing with a minimum volume of 20 mL DPBS using a pipette. Excess DPBS was removed by gently shaking the tissue inserts and blotting the bottom of the tissue inserts with blotting paper.
- Observable damage in the tissue due to washing: No
- Modifications to validated SOP: No
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h ± 15 min
- Spectrophotometer: microplate reader (ELx800, BioTek Instruments GmbH, Bad Friedrichshall, Germany)
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 2
PREDICTION MODEL / DECISION CRITERIA:
- 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 applied: 20 ± 3 mg
NEGATIVE CONTROL
- Amount applied: 40 ± 3 µL
POSITIVE CONTROL
- Amount applied: 40 ± 3 µL - Duration of treatment / exposure:
- 3 min or 1 h
- Number of replicates:
- 2
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 88.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h
- Value:
- 91.77
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
ACCEPTANCE OF RESULTS (see any other information on results):
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes - Interpretation of results:
- other: not corrosive (GHS Cat. 1)
- Conclusions:
- In an in vitro skin corrosion test (reconstructed human epidermis model, RHE) according to OECD Guideline 431, a cell viability of 88.5 % after 3 min incubation and 91.77 % after 1 h incubation was determined. According to the evaluation criteria, the test substance did not show skin corrosive properties.
- Executive summary:
In an in vitro skin corrosion test (reconstructed human epidermis model, RHE) according to OECD Guideline 431, 20 mg L-Aspartic acid sodium salt monohydrate was applied topically to a human reconstructed skin model followed by determination of the cell viability. Cell viability was determined by enzymatic conversion of vital dye MTT into a blue formazan salt and measurement of the formazan salt after extraction from tissues. No direct MTT-reducing properties of the test substance were observed. Duplicates of the human skin RHE-model were treated with the test substance or the negative control for 3 minutes and additional 1 hour. Duplicates with the positive control were only treated for 1 hour. 40 µL of either the negative control (deionised water) or the positive control (potassium hydroxide, 8N) were applied to the tissues. Results of the positive and negative control were valid. After treatment with the test substance, a mean cell viability of 88.50 % (3 min incubation) or 91.77 % (1 h incubation) was determined.
Under the test conditions, the test substance is not considered to possess a corrosive potential to skin. Furthermore, it was assumed, that the anhydrate form has the same corrosive potential to the skin and thus the result of the test item is also applicable.
Reference
Acceptability of the Test
Acceptability of the Negative Control: The negative control OD values were 2.019, 2.059, 1.675 and 1.699 and, thus, in the range of ≥ 0.8 and ≤ 3.0.
Acceptability of the Positive Control: After treatment with the positive control (potassium hydroxide, 8N) the mean viability value was 0.59 % after 1 hour exposure and, thus, lower than 15 %.
Test Substance Data Acceptance Criteria: The range between identically treated tissues was less than 30 % (20.74 % after 3 minutes exposure and 0.65 % after 1 hour exposure).
The study met all acceptance criteria.
The results obtained after treatment of the reconstructed human epidermis model with Art. 11195 (L-Aspartic acid sodium salt monohydrate) are given in the following table:
|
Tissue 1 |
Tissue 2 |
Mean |
CV |
||||
OD |
Viability (%) |
OD |
Viability (%) |
OD |
Viability (%) |
Viability (%) |
||
Negative Control |
3 min |
2.019 |
99.02 |
2.059 |
100.98 |
2.039 |
100.00 |
1.39 |
1 h |
1.675 |
99.30 |
1.699 |
100.70 |
1.687 |
100.00 |
0.99 |
|
Positive Control |
1 h |
0.009 |
0.51 |
0.011 |
0.66 |
0.010 |
0.59 |
17.90 |
Test Substance |
3 min |
1.635 |
80.19 |
1.974 |
96.81 |
1.804 |
88.50 |
13.28 |
1 h |
1.553 |
92.07 |
1.543 |
91.48 |
1.548 |
91.77 |
0.46 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin:
In an in vitro skin corrosion test (reconstructed human epidermis model, RHE) according to OECD Guideline 431 (reference 7.3.1 -1), 20 mg L-Aspartic acid sodium salt monohydrate was applied topically to a human reconstructed skin model followed by determination of the cell viability. Cell viability was determined by enzymatic conversion of vital dye MTT into a blue formazan salt and measurement of the formazan salt after extraction from tissues. No direct MTT-reducing properties of the test substance were observed. Duplicates of the human skin RHE-model were treated with the test substance or the negative control for 3 minutes and additional 1 hour. Duplicates with the positive control were only treated for 1 hour. 40 µL of either the negative control (deionised water) or the positive control (potassium hydroxide, 8N) were applied to the tissues. Results of the positive and negative control were valid. After treatment with the test substance, a mean cell viability of 88.50 % (3 min incubation) or 91.77 % (1 h incubation) was determined.
Under the test conditions, the test substance is not considered to possess a corrosive potential to skin. Furthermore, it was assumed, that the anhydrate form has the same corrosive potential to the skin and thus the result of the test item is also applicable.
The present study is required for a registration under another legislation, no further testing is necessary (e.g. skin irritation). Under REACH, the test substance is considered to be registrated using the Annex III exemption. Therefore, no studies on the skin or eye irritating properties of the test substance were conducted. However, all available information on health effects of the test substance were included in this REACH-registration dossier.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.
As a result the substance is not considered to be classified for skin corrosion under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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.
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