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EC number: 939-523-2 | CAS number: 1471312-55-6
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted in 2010
- 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)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit
Test material
- Reference substance name:
- Alcohols, C8-10, ethoxylated, sulfates, sodium salts
- EC Number:
- 939-523-2
- Cas Number:
- 1471312-55-6
- Molecular formula:
- not available
- IUPAC Name:
- Alcohols, C8-10, ethoxylated, sulfates, sodium salts
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- paste
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm™
- Source strain:
- other: not applicable (human skin model)
- Details on animal used as source of test system:
- not applicable (human skin model)
- Justification for test system used:
- The used test system is in line with OECD TG 439.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- An in-vitro study with the EpiDermTM human skin model comprising a reconstructed epidermis with a functional stratum corneum was performed. The EpiDermTM tissues were obtained by MatTek. The tissue was moistened with 25 µL DPBS (Dulbecco`s Phosphate Buffered Saline) to ensure good skin contact before 25 mg of the test substance were applied directly atop the EpiDermTM tissue. DPBS was used as negative control while 5% SDS (Sodium dodecyl sulfate) was used as positive control. A total of 3 tissues per dose group were used in duplicate. Irritation properties of the test substance are identified by the decrease of cell viability after exposure as determined by using the MTT reduction assay. The tissues were maintained at 37 °C in humidified atmosphere (5% CO2/95% air). All media used during the study (for instance the incubation medium and MTT medium) were pre-warmed. After treatment, tissues were incubated at 37 °C in humidified atmosphere for 35 min and placed at room temperature thereafter. After 60 min the tissues were washed with DPBS, placed in pre-warmed incubation medium and were further incubated for 24 h at 37 °C in humidified atmosphere. After a medium change the tissues were incubated for additional 18 h prior to incubation in MTT medium for 3 h. After incubation in MTT the tissues were three times rinsed with DPBS before extraction of the reduced MTT with isopropanol for 2 hours. Per each tissue two aliquots of the extract were transferred into 96-well plates and analysed in a plate spectrophotometer. The MTT reducing potential and the coloring potential of the test substance as possible confounding factors were assessed.
Assessment criteria:
A test substance is concluded to be irritating if the relative mean tissue viability after 60 minute exposure and 42 hours post-treatment incubation is below 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of all tissues
- Run / experiment:
- 60 min exposure
- Value:
- 6.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- Reversibility: not applicable.
- Other effects / acceptance of results:
- The test item showed irritating potential (for details, see Table 1). However, only two experiments with test item treated tissues instead of three were evaluated due to loss of one tissue during washing. As each experiment was performed in duplicate 4 tissues were assessed. The test meets the acceptance criteria (See: Any other information on materials and methods incl. tables.)
Any other information on results incl. tables
Table 1: Summary of results
Test group |
n |
Treatment period (min) |
Mean OD550value |
Viability (%) |
Mean inter tissue viability difference (%) |
Negative control |
3 |
60 |
1.78 |
100 |
15.8 |
Test item |
2* |
60 |
0.12 |
6.8 |
0.8 |
Positive control |
3 |
60 |
0.12 |
6.6 |
0.9 |
* Only two test item treated tissues instead of three were evaluated due to loss of one tissue during washing.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irrit. 2 (H315) according to Regulation (EC) No 1272/2008
- Conclusions:
- There is regulatory acceptance in the EU that a substance can be considered non-irritant and non-corrosive based on a negative result in the Reconstructed human epidermis test method (in vitro skin irritation). A positive in vitro irritation response is not conclusive with respect to classification of the test substance as irritant (Skin Irritant Cat. 2) or corrosive or Skin Corrosive Cat. 1) and therefore requires further evaluation and/or data generation. Previously, an in vitro skin corrosion test was conducted (Study-ID: 122043) with the result "non-corrosive". The outcome of the present skin irritation test is positive. Thus, taken together the results from both tests, it can be concluded that the substance meets the criteria as a Skin Irritant Cat. 2 (H315).
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