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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 March 2010 to 09 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to internationally accepted guidelines and to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry ofAgriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nohsan No 8147, Agricultural Production Bureau, November 24, 2000.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
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 given
- Lot/batch No.: 9G28W1
- Expiration date of the lot/batch: End of July 2010
- Storage condition of test material: Ca. 4°C in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 225 to 234 g
- Fasting period before study: overnight prior to and approximately four hours after dosing.
- Housing: They were housed in groups of three rats of the same sex, in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding.
- Diet (e.g. ad libitum): Rat and Mouse No.1 Maintenance Diet ad libitum except for overnight prior to and approximately four hours after dosing.
- Water (e.g. ad libitum): ad libitum from public supply
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23
- Humidity (%): 40 to 70
- Air changes (per hr): not reported, the animal room was kept at positive pressure with respect to the outside by its own supply of filtered fresh air, which was passed to atmosphere and not re-circulated.
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 24 March 2010 To: 09 April 2010
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As some previous toxicological information indicated that the test material should not be toxic the
initial dose level was 2000 mg/kg. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6 females (3 dosed first, results assessed then a further 3 dosed)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Day 1 frequent intervals, on subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only).
The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: all rats humanely killed on day 15 for macroscopic examination
- Other examinations performed: clinical signs, bodyweight, organ weights, histopathology, other: All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: Clinical signs of reaction to treatment comprised loose faeces, reduced body tone, underactivity, unsteady gait, elevated gait and piloerection seen in all females dosed at 2000 mg/kg. These signs were first noted from approximately thirty minutes after d
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information: or unclassified (CLP)
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of SOFTANOL 30 was demonstrated to be greater than 2000 mg/kg bodyweight. SOFTANOL 30 is included in Category 5 or unclassified, according to the Globally Harmonised System (GHS), (UNITED NATIONS, 2005).
- Executive summary:
In an acute oral toxicity study realised according to the OECD guideline 423 and in compliance with GLP, groups of 3 female Sprague Dawley rats were given a single oral dose of Softanol 30 in corn oil at the dose of 2000mg/kg and observed for 14 days.
There were no deaths during the study. Clinical signs of reaction to treatment were first noted from approximately thirty minutes after dosing and had resolved completely by Day 5. The acute median lethal oral dose (LD50) to female rats of SOFTANOL 30 was demonstrated to be greater than 2000 mg/kg bodyweight.
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