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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- existing in vivo study
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 12 May to 10 June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with an internationally accepted guideline (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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%
- Impurities (identity and concentrations): not applicable
- Lot/batch No.: 9G28W1
- Expiration date of the lot/batch: End July 2010
- Storage condition of test material: ca. 4°C in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
-Source: United Kingdom
- Age at study initiation: approximately 8- 12 weeks
- Weight at study initiation: 17.3 to 22.2 g
- Housing: individually in polycarbonate cages with woodflake bedding.
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): freely available
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 40 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 18 May to 9 June 2010
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10 and 25% v/v
- No. of animals per dose:
- 4 females/dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: A vehicle trial was conducted and Softanol 30 showed that it formed a clear solution at 50% v/v in acetone:olive oil (4:1 v/v), which was satisfactory for dose administration.
- Irritation: signs of irritation were seen over the dosed area on Days 2 to 4 (100% v/v) and Days 2 and 3 (Group 50%).
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Pooled treatment group approach
- Criteria used to consider a positive response: the test substance is regarded as a sensitizer if at least one concentration of the test substance
results in a three-fold greater increase in 3HTdR incorporation compared to control values
TREATMENT PREPARATION AND ADMINISTRATION:
- Preliminary test: Three females were treated with one of three concentrations of the test substance. The mice were treated by daily application of 25 μl of appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3).
- Main test: Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 μl of the appropriate concentration of the test substance to the dorsal surface of each ear for three consecutive days (Days 1-3).
In the main phase of the study, five days following the first topical application of test substance (Day 6) all mice were treated with 250 μl of phosphate buffered saline containing 3H-methyl Thymidinea (3HTdR: 80 μCi/mL) giving a nominal 20 μCi to each mouse.
A single cell suspension of lymph node cells (LNC) was prepared by gentle mechanical disaggregation through a stainless steel gauze (200 mesh size). The pooled LNC were then washed by adding 10 mL phosphate buffered saline, pelleted at 190 x g for 10 minutes and resuspended. The cells were washed twice again and resuspended in 3 mL trichloroacetic acid (TCA: 5%) following the final wash. After overnight incubation with 5% TCA at 4°C, the precipitate was recovered by centrifugation and resuspended in 1 mL 5% TCA and transferred to 10 mL Ultima gold scintillation fluid on Day 7. 3HTdR incorporation was measured by β-scintillation counting.
Results and discussion
- Positive control results:
- Responses to the positive control substance hexyl cinnamic aldehyde (HCA), in contemporaneous studies demonstrated the reliability and sensitivity of this assay to detect skin sensitization potential in this laboratory.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 5% v/v 1.6 10% v/v 1.7 25% v/v 5.1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 5% v/v 3994.75 10% v/v 4477.95 25% v/v 13141.35
Any other information on results incl. tables
The test substance is regarded as a sensitizer if at least one concentration of the test substance results in a three-fold greater increase in 3HTdR incorporation compared to control values.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Softanol 30 is regarded as a potential skin sensitizer.
- Executive summary:
In a dermal sensitization study realised according to the OECD guideline 429 and in compliance with GLP (HLS 2010, PLZ0020), Softanol 30 in acetone/olive oil (4:1 v/v) at 5, 10 and 25 % was tested on female CBA mice (4/group), using the LLNA (Local Lymph Node Assay) .
Animals were treated by daily application of 25µl of the appropriate concentration to the dorsal surface of each ear for 3 consecutive days and all mice were treated with 250 μl of phosphate buffered saline containing 3H-methyl Thymidine (3HTdR: 80 μCi/mL) giving a nominal 20 μCi to each mouse on Day 6.
Stimulation index were 1.6, 1.7 and 5.1 at 5, 10 and 25%. Therefore Softanol 30 is regarded as a potential skin sensitizer.
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