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EC number: 700-937-1 | CAS number: 1312021-45-6
- 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:
- key study
- Study period:
- 18 - 21 October 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Kaiser-Friedrich-Str. 7, 55116 Mainz, Germany
Test material
- Reference substance name:
- Fatty acids, C10-12, esters with polylactic acid, sodium salts
- EC Number:
- 700-937-1
- Cas Number:
- 1312021-45-6
- Molecular formula:
- not available
- IUPAC Name:
- Fatty acids, C10-12, esters with polylactic acid, sodium salts
- Test material form:
- liquid: viscous
1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm (EPI-200)
- Justification for test system used:
- The test material is applied topically to a three dimensional human skin model. The skin corrosion test refers to the production of irreversible tissue damage in the skin following the application of a test material on a human skin model. The model allows identification of corrosive chemical substances and mixtures.
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm, Epi-200-Kit. The EpiDerm tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differenciated model of the human epidermis.
- Tissue vendor: MatTek Corporation in Ashland, USA
- Tissue batch number(s): 15650
- Delivery date: 19 Oct 2011
- Date of initiation of testing: 21 Oct 2011
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: thoroughly rinsed with phosphate buffered saline (PBS) and blotted with sterile cellulose tissue
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/mL
- Incubation time: 3 h
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 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%.]
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%. - Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- Amount/concentration applied:
- In average 25.6 mg
- Duration of treatment / exposure:
- 3 minutes / 1 h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: relative absorbance / optical density (OD)
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 3 minutes
- Value:
- 2.103
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- other: relative absorbance / optical density (OD)
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 1 h
- Value:
- 0.408
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The criterion for optical density of the negative control (> 0.8) was fulfilled: optical density was 2.109 (3 minutes) and 1.855 (1 h).
- Acceptance criteria met for positive control: The positive control showed a clear corrosive effect: the value of the 3 minutes experiment was 21.5% and the value of the 1 h experiment was 14.7%.
- Acceptance criteria met for variability between replicate measurements: Values for negative control and for positive control were within the range of historical data of the test facility.
Any other information on results incl. tables
The test item is considered not corrosive since the test item fulfilled the criteria given for non corrosive substances which are:
> 50% of negative control of Formazan production after 3 min. incubation time
> 15% of negative control of Formazan production after 1 h incubation time
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corrosive Cat. 1, 1A, 1B/C) based on a positive result in the Reconstructed human epidermis test method (in vitro skin corrosion). A negative in vitro corrosivity response is not conclusive with respect to non-classification or classification as a skin irritant and therefore requires further evaluation and/or data generation.
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