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Diss Factsheets
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EC number: 308-072-8 | CAS number: 97862-28-7
- 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:
- weight of evidence
- Study period:
- 2012-2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- 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 skin irritation, which is considered adequate in combination with the in vitro corrosivity testing.
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction product of C18 unsatd. fatty acid diethanolamide and maleic anhydride, sulphonated, sodium salt
- IUPAC Name:
- Reaction product of C18 unsatd. fatty acid diethanolamide and maleic anhydride, sulphonated, sodium salt
- Test material form:
- other: lyophilisate
- Details on test material:
- - Name of test material (as cited in study report): butanedioic acid, sulfo-, 4-(2-((2-hydroxyethyl)amino)ethyl)ester, N-C18-unsatd. acyl derivs., disodium salts; Sulfosuccinate of Fatty Acid Diethanolamide, sodium salt ; Sulfosuccinate of Fatty Acid Diethanolamide 30% AS
- Physical state: Lyophilisate, light orange solid
- Analytical purity: 29.9% active ingredient
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: 2012-03-19
- Lot/batch No.: FL21-22-RS
- Expiration date of the lot/batch: March 2014
- Stability under test conditions: Stable
- Storage condition of test material: At +10°C to +25°C (0-40°C acceptable)
- Other: Manufacturer/supplier: TFL France S.A.S. , 4, rue de l’industrie, 68333 Huningue Cedex , France
Constituent 1
Test animals
- Species:
- other: a three-dimensional human skin model
- Strain:
- other: The Skin model EST-1000 was used.
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 mg of the supplied test item were dissolved in 1 mL water for injection. 30 µL Butanedioic acid, sulfo-, 4-(2-((2-hydroxyethyl)amino)ethyl) ester, N-C18-unsatd. acyl derivs., disodium salts were applied to the skin model with a surface area of 0.6 cm2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability test group
- Value:
- 110.5
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 20 minutes, followed by 42h incubation . Remarks: % versus negative control group . (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability positive control group
- Value:
- 1.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 20 minutes, followed by 42h incubation . Remarks: % versus negative control group . (migrated information)
Any other information on results incl. tables
The cell viability was measured by determining the optical density (OD) at a wavelength of 540 nm. An exposure time of 20 minutes was employed.
The test item, Butanedioic acid, sulfo-, 4 -(2 -((2 -hydrocyethyl)amino)ethyl)ester, N-C18 -unsatd. acyl derivs., disodium salts, was applied to the model skin surface. Water for injection was used as the negative control. 5% aqueous sodium dodecyl sulphate (SS) was used as the positive reference item.
The mean viability of the cells exposed to the test item was 110.5% of the mean negative control value. The OD540 values were well above the cut-off percentage cell viability value (that distinguishes irritant from non-irritant test items) of >50% for a 20-minute exposure.
The test item was considered to be non-cytotoxic and predicted to be not irritant to skin.
The viability of cells treated with the positive reference item, 5% SDS,was 1.3% of the negative controls and below the 50% cut-off value. Hence, 5% SDS is predicted to cause pronounced skin irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the present test conditions Butanedioic acid, sulfo-, 4-(2-((2-hydroxyethyl)amino)ethyl) ester, N-C18-unsatd. acyl derivs., disodium salts, tested at an exposure time of 20 minutes, was non-cytotoxic and not irritant to skin in an experiment with 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 irritation by Butanedioic acid, sulfo-, 4 -(2 -((2 -hydroxyethyl)amino)ethyl) ester, N-C-18 -unsatd. acyl derivs., disodium salts to human skin, in an experiment with an artificial three-dimensional model of human skin.
The EST1000 model was employed.
The cell viability was measured by determining the optical density (OD) at 540 nm. An exposure time of 20 minutes was employed.
The test item, Butanedioic acid, sulfo-, 4 -(2 -((2 -hydroxyethyl)amino)ethyl) ester, N-C18 -unsatd. acyl derivs., disodium salts, was applied to model skin surface. Water for injection was used as the negative control. 5% aqueous sodium dodecyl sulphate (SDS) was used as the positive reference item.
The mean viability of the cells exposed to the test item was 110.5% of the mean negative control value. The OD540values were well above the cut-off percentage cell viability value (that distinguishes irritant from non-irritant test items) of >50% for a 20-minute exposure.
The test item was considered to be non-cytotoxic and predicted to be not irritant to skin.
The viability of cells treated with the positive reference item, 5% SDS,was 1.3% of the negative controls and below the 50% cut-off value. Hence, 5% SDS is predicted to cause pronounced skin irritation.
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