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EC number: 294-268-8 | CAS number: 91697-07-3
- 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:
- 2012-2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid testing guidance. In combination with the in vitro corrosion test, it is considered relevant, adequate and reliable for classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts
- EC Number:
- 290-836-4
- EC Name:
- Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts
- Cas Number:
- 90268-36-3
- Molecular formula:
- C12 - C18 C16 H30 O7 S 2Na - C22 H42 O7 S 2Na
- IUPAC Name:
- Butanedioic acid, sulfo-, 1-C12-18 (even numbered)-alkyl esters, disodium salts
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts
- Physical state: White powder
- Analytical purity: >95%
- Composition and impurities of test material, percentage of components: See confidential details
- Purity test date: 2012-07-03
- Lot/batch No.: 008249628
- Expiration date of the lot/batch: 2014-03-20
- Stability under test conditions: stable
- Storage condition of test material: At +10° to +25°C
- Other: Manufacturer/supplier: BASF Personal Care and Nutrition GmbH
Constituent 1
Test animals
- Species:
- other: three-dimensional reconstructed human epidermis model
- Strain:
- other: EST1000
- Details on test animals or test system and environmental conditions:
- Not applicable
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability test group
- Value:
- 98.3
- 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 viabilitypositive control group
- Value:
- 1.2
- 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 viabilitywas measured by determining theoptical density (OD) at a wavelength of 540 nm. An exposure time of 20 minutes was employed.
The test item, Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts,was applied to the 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 98.3% 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 1.2% 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:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the present test conditions the test item, applied 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 the test item 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 a wavelength of 540 nm. An exposure time of 20 minutes was employed. The test item was applied to the 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 98.3% 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 1.2% 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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