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EC number: 500-002-6 | CAS number: 9002-92-0 1 - 2.5 moles ethoxylated
- 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: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- The toxicology and biological properties of test chemical
- Author:
- D.A.Berberian et al.,
- Year:
- 1 965
- Bibliographic source:
- Toxicology and Applied Pharmacology.; 1965
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The test material was tested as an aqueous solution and as an ingredient of an aerosol contraceptive formulation containing 20% test chemical to determine if sensitization is produced by the test material on group of seven male guinea pigs.
- GLP compliance:
- no
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Non-LLNA Draize test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- Dodecan-1-ol, ethoxylated
- EC Number:
- 500-002-6
- EC Name:
- Dodecan-1-ol, ethoxylated
- Cas Number:
- 9002-92-0
- Molecular formula:
- C58H118024
- IUPAC Name:
- Dodecan-1-ol, ethoxylated
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Dodecan-1-ol, ethoxylated
- Substance type: Organic
- Physical state: liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- Not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: Distilled water
- Concentration / amount:
- First group: a series of ten intracutaneous injections of a 0.02% solution
Second group: a series of ten injections of a 0.1% solution of the formulation were given
Third group: sterile distilled water was injected. - Day(s)/duration:
- 3 weeks
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: Distilled water
- Concentration / amount:
- 0.05 ml
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- seven guinea pigs/group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24 hours
- Test groups: seven guinea pigs/group
- Control group:
- Site: not specified
- Frequency of applications: every other day, three times each week.
- Duration: 3 weeks
- Concentrations: 0.02% and 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 2 week
- Exposure period: 24 hours
- Test groups: seven guinea pigs/group
- Control group: not specified
- Site: not specified
- Concentrations: 0.05ml
- Evaluation (hr after challenge): after 24 hours
OTHER: Twenty-four hours after each injection, the injection sites were examined and the dimensions and color of the reactions were recorded. - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05ml
- No. with + reactions:
- 0
- Total no. in group:
- 7
- Clinical observations:
- Neither the 0.02% solution of test chemical nor a 0.1% solution of the aerosol formulation containing 20% of test chemical produced direct or delayed sensitization reactions.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Neither the 0.02% solution of test chemical nor a 0.1% solution of the aerosol formulation containing 20% of test chemical produced direct or delayed sensitization reactions in adult male guinea pigs when injected intracutaneously.
Hence the test chemical was considered to be a non-skin sensitizer under the tested conditions. - Executive summary:
The test material was tested as an aqueous solution and as an ingredient of an aerosol contraceptive formulation containing 20% test chemical to determine if sensitization reactions were produced on group of 7 male guinea pigs.
To a group of seven male guinea pigs a series of ten intracutaneous injections of a 0.02% solution of test chemical were administered; to a second group a series of ten injections of a 0.1% solution of the formulation were given; and to a third group (control) sterile distilled water was injected.
The sensitizing injections were given every other day, three times each week. The volume of the first dose was 0.05 ml and that of the other nine was 0.1 ml. Two weeks after the tenth sensitizing injection, the guinea pigs received a single challenge injection of 0.05 ml of a freshly prepared solution of the material to which they were sensitized. Twenty-four hours after each injection, the injection sites were examined and the dimensions and color of the reactions were recorded.
Intracutaneous injections of all the solutions, including the sterile water control, produced a small raised anemic area approximately 7 mm in diameter and 1 mm in height. This reaction was transient and did not last for more than 3 hours.
Further neither the 0.02% solution of test chemical nor a 0.1% solution of the aerosol formulation containing 20% of test chemical produced direct or delayed sensitization reactions in adult male guinea pigs when injected intracutaneously. Hence the test chemical was considered to be a non-skin sensitizer under the tested conditions.
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