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EC number: 614-295-4 | CAS number: 68131-40-8
- 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:
- 13 April 2010 to 19 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted to draft OECD guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline For The Testing of Chemicals Draft proposal for a new guideline In Vitro Skin Irritation (OECD2009).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Test 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:
- Alcohols, secondary C11-15, ethoxylated
- EC Number:
- 614-295-4
- Cas Number:
- 68131-40-8
- Molecular formula:
- C(11-15) H(23-31) O (C2H4O)xH where n= approximately 3
- IUPAC Name:
- Alcohols, secondary C11-15, ethoxylated
- Details on test material:
- - Name of test material (as cited in study report): Softanol 30
- Physical state: Slightly yellow clear liquid
- Analytical purity: 100%
- Purity test date: Not reported
- Lot/batch No.: 9G28W1
- Expiration date of the lot/batch: 31 July 2010
- Storage condition of test material: Ca. +4°C in the dark
Constituent 1
Test animals
- Species:
- other: EPISKIN human epidermis skin constructs
- Strain:
- other: not applicable
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The negative control was sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium. The positive control was 5% Sodium Dodecyl Sulphate (SDS) in distilled water.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 15+/-0.5 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- See any other information below.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: viability percentage (vs. negative control)
- Value:
- 64.7
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Max. score: 100.0. (migrated information)
Any other information on results incl. tables
Table 1 EPISKIN Results
Sample |
Tissue viability as percentage of mean OD negative control |
Prediction MTT endpoint |
|||
|
Replicate Tissues |
Mean ± SD |
|||
|
a |
b |
c |
|
|
Negative Control |
112.8 |
86.3 |
100.9 |
100.0 ± 13.3 |
Not applicable |
Positive control |
7.5 |
14.0 |
6.5 |
9.3 ± 4.1 |
Irritant |
Softanol 30 |
51.9 |
63.8 |
78.5 |
64.7 ± 13.3 |
Non-irritant |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- It was concluded that the test substance, Softanol 30, with a mean tissue viability of 64.7 ± 13.3%, was predicted as a non-irritant to the skin.
- Executive summary:
In an Episkin test realised according to the OECD guideline and in compliance with GLP, undiluted Softanol 30was applied for 15 minutes on human epidermis skin constructs and the effect on cell viability was evaluated (HLS 2010, PLZ0016). Appropriate positive and negative controls were used.
The tissue viability was 64.7+/-13.3% of the control value, and Softanol 30 was therefore not classified as irritant.
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