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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 February 1997 to 10 March 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted to internationally accepted guidelines and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute 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: Liquid, slightly yellow
- Analytical purity: >99% by wt.
- Lot/batch No.: W70127
- Expiration date of the lot/batch: 27 June 1997
- Storage condition of test material: at room temperature {approx. 20°C, away from direct sunlight)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanIbm: WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf, Switzerland
- Age at study initiation: (age when treated) males 8 weeks, females 11 weeks
- Weight at study initiation: (when treated) Males: 225.2 - 240.3 8, Females: 191.9- 223.8 g
- Fasting period before study: no
- Housing: During acclimatization in groups of five in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz). During treatment and observation individually in Makrolon type-3 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, batch 81/96 rat maintenance diet (Kliha Muhlen AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 4-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 17 February 1997 To: 10 March 1997
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back (clipped)
- % coverage: 10
- Type of wrap if used: A semi-occlusive dressing wrapped around the abdomen and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 mL
- Concentration (if solution): 100%
- Constant volume or concentration used: yes - Duration of exposure:
- 24 Hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Four times during test day 1 and once daily for surviving animals during days 2-15. Weighing: On test day 1 (pre-administration), 8 and 15 for surviving animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Each animal was examined for changes in appearance and behaviour (with special emphasis on the application area, except for the time when the semi-occlusive dressing was in place) four times during day 1, and once daily for surviving animals during days 2-15. All abnormalities were recorded. - Statistics:
- The LOGIT-Model could not be used as no deaths occurred.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No clinical signs of systemic toxicity of the test article on the skin at the application site were observed during the observation period. Local effects such as general erythema and scales on the back were observed in all animals.
- Gross pathology:
- No macroscopic organ findings were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information: or unclassified (CLP)
- Conclusions:
- LD50 for male and female rats was >2000 mg/kg.
- Executive summary:
In an acute dermal toxicity study realised according to the OECD guideline 402 and in compliance with GLP, groups of 5 male and 5 female rats were dermally exposed to undiluted Softanol 30 for 24 hours to 10% of body surface area (back) at doses of 2000mg/kg bw. Animals then were observed for 14 days.
No deaths occurred during the study. No clinical signs of systemic toxicity of the test article on the skin at the application site were observed during the observation period. Local effects such as general erythema and scales on the back were observed in all animals. LD50 for male and female rats was >2000 mg/kg.
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