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Diss Factsheets
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EC number: 939-704-6 | 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:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods and is considered relevant and reliable for classification. It is an in vitro study predicting corrosivity, which is considered adequate in combination with the in vitro irritation testing.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts
- EC Number:
- 939-704-6
- Cas Number:
- 867040-07-1
- Molecular formula:
- Molecular formula cannot be given as the substance is a mixture
- IUPAC Name:
- Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18 unsaturated alkyl) tetrasodium salts
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- other: a three-dimensional reconstructed human epidermis model
- Strain:
- other: The EST1000 model was employed.
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Details on study design:
- TEST SITE
- Area of exposure: skin model with a surface area of 0.6 cm2
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Dulbecco’s phosphate buffered saline (D-PBS)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control, 1 h
- Value:
- 12.3
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- positive control, 3 min.
- Value:
- 21.6
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- test substance, 1 h
- Value:
- 74.1
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- test substance, 3 min.
- Value:
- 92.2
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The test item, Aspartic acid, N-(3 -carboxy-1 -oxo-sulfopropyl)-N-(C16 -C18(even numbered), C18unsaturated alkyl) tetrasodium salts, was applied to the skin surface. Water for injection was used as the negative control. 8N KOH was used as the positive reference item. Two exposure times of 3 minutes or 1 hour were employed.
In comparison to the negative controls, the mean viability of cells exposed to the test item was 92.2% after a 3-minute exposure period and 74.1% after a 1-hour exposure.The OD540 values were well above the cut-off percentage cell viability values distinguishing corrosive from non-corrosive test items of <50% or <15% for a 3-minute or 1-hour treatment, respectively. Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.
The mean viability of cells treated with the positive reference item 8 N KOH were 21.6% (3-minute incubation) and 12.3% (1-hour incubation) of the negative controls and were below the cut-off values and well within the range of historical background data of 3.3 – 47.4% (3-minute incubation) and 0.2 – 4.9% (1-hour incubation) of the negative controls (the last 6 experiments, not audited by the LPT QAU-department). Hence, 8 N KOH caused pronounced corrosion in this skin model and is predicted to be corrosive to human skin.
Applicant's summary and conclusion
- Interpretation of results:
- other: predicted non-corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the present test conditions Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts tested at two exposure times of 3 minutes or 1 hour was non-corrosive to skin in an experiment employing an artificial three-dimensional model of human skin.
- Executive summary:
The purpose of this study was to determine cytotoxic properties to skin cells which might lead to corrosion by Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts to human skin, in an experiment with an artificial three-dimensional model of human skin. The EST-1000 model was employed.
The test item, Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts, was applied to the skin surface. Water for injection was used as the negative control. 8 N KOH was used as the positive reference item.Two exposure times of 3 minutes or 1 hour were employed. In comparison to the negative controls, the mean viability of cells exposed to the test item was 92.2% after a 3-minute exposure period and 74.1% after a 1-hour exposure.The OD540values were well above the cut-off percentage cellviability values distinguishing corrosive from non-corrosive test items of <50% or<15% for a 3-minute or 1-hour treatment, respectively. Therefore, the test item was non-corrosive in this skin model and is predicted to be non-corrosive to human skin.
The mean viability of cells treated with the positive reference item 8 N KOH were 21.6% (3-minute incubation) and 12.3% (1-hour incubation) of the negative controls and were below the cut-off values. Hence, 8 N KOH caused pronounced corrosion in this skin model and is predicted to be corrosive to human skin.
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