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EC number: 500-155-9 | CAS number: 62362-49-6 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May to July 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The target substance, Octadecan-1-ol, ethoxylated, phosphates, and the analogous reference substances, Phosphoric acid, octadecyl ester, and Alcohols, C16-18, ethoxylated, phosphates, are fatty alcohol phosphate esters and weak anionic surfactants with extremely low water solubility and very high lipophilicity. None of them is expected to be bioavailable.
The skin sensitization information available from SAR analysis, the lack of bioavailability based on Lipinski’s Rule, the results of the Ames Test using the target substance, and the results of an LLNA on the reference substance, Phosphoric acid, octadecyl ester, provide sufficient evidence to conclude that Octadecan-1-ol, ethoxylated, phosphates is not a skin sensitizer.
The target and reference substances, are anionic surfactants, with low water solubility and high log Kow. The SAR analysis shows that both target and reference substances are similar in this respect and may be hydrolyzed in water, releasing phosphoric acid and fatty AEs or fatty alcohols under neutral conditions. The SAR analysis for ER binding also shows that both target and reference substances, their aqueous hydrolysates, and skin metabolites are considered non-estrogen binders.
Based upon all of the information presented, read-across from the existing experimental data for the analogous reference substances to the target substance is scientifically justified for this endpoints.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (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:
- Octadecyl dihydrogen phosphate
- EC Number:
- 220-983-1
- EC Name:
- Octadecyl dihydrogen phosphate
- Cas Number:
- 2958-09-0
- Molecular formula:
- C18H39O4P
- IUPAC Name:
- octadecyl dihydrogen phosphate
- Reference substance name:
- Hexadecyl dihydrogen phosphate
- EC Number:
- 222-581-1
- EC Name:
- Hexadecyl dihydrogen phosphate
- Cas Number:
- 3539-43-3
- Molecular formula:
- C16H35O4P
- IUPAC Name:
- hexadecyl dihydrogen phosphate
- Reference substance name:
- Dioctadecyl hydrogen phosphate
- EC Number:
- 221-237-8
- EC Name:
- Dioctadecyl hydrogen phosphate
- Cas Number:
- 3037-89-6
- Molecular formula:
- C36H75O4P
- IUPAC Name:
- dioctadecyl hydrogen phosphate
- Reference substance name:
- Dihexadecyl hydrogen phosphate
- EC Number:
- 218-594-7
- EC Name:
- Dihexadecyl hydrogen phosphate
- Cas Number:
- 2197-63-9
- Molecular formula:
- C32H67O4P
- IUPAC Name:
- dihexadecyl hydrogen phosphate
- Reference substance name:
- hexadecyl octadecyl hydrogen phosphate
- Cas Number:
- 93803-11-3
- Molecular formula:
- C34H71O4P
- IUPAC Name:
- hexadecyl octadecyl hydrogen phosphate
- Reference substance name:
- Unidentified impurities, likely the C16 and C18, and mixed C16/C18 trialkyl phosphates based 31P NMR chemical shift.
- Molecular formula:
- N/A
- IUPAC Name:
- Unidentified impurities, likely the C16 and C18, and mixed C16/C18 trialkyl phosphates based 31P NMR chemical shift.
- Test material form:
- solid
- Details on test material:
- CAS Number 39471-52-8
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
impurity 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Animals were nulliparious and non-pregnant
At least 5 days of acclimatisation provided
Weight: 15 to 23 g
Age: 8 to 12 weeks old
Animals individually housed in solid floor suspended cages.
Free access to food and tap water available for the animals.
The temperature and humidity were controlled to remain within the range 19 - 25ºC and 30 to 70% respectively.
Study design: in vivo (LLNA)
- Vehicle:
- other: Butanone
- Concentration:
- 25ul of solution with a concentration of 10, 5 & 2.5% w/w in butanone.
- No. of animals per dose:
- Four.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control (85%) was considered to be a sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Stimulation index results: 2.5% w/w concentration, 1.99 stimulation index 5% w/w concentration, 1.45 stimulation index 10% w/w concentration, 2.66 stimulation index
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- The results of a study completed at good quality European Union (EU) laboratory according to OECD Guideline 429 (Local Lymph node assay) and according to GLP determined that Phosphoric acid, octadecyl ester was a non-sensitizer. The disintegrations per minute (DPM) were found to be: Vehicle, 1574.25 (dpm) 2.5% w/w concentration, 3129.90 (dpm) 5% w/w concentration, 2275.33 (dpm) 10% w/w concentration, 4192.38 (dpm)
Any other information on results incl. tables
Study completed at good quality European Union (EU) laboratory according to OECD Guideline 429 (Local Lymph node assay) and according to GLP. The Skin sensitization study determined that the test material was found to be a non-sensitizer under the conditions of the test.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not sensitising.
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