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EC number: 947-763-4 | CAS number: -
- 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:
- weight of evidence
- Study period:
- From April 16, 2001 to May 24, 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A Human Repeated Insult Patch Test (HRIPT) was conducted to determine the skin sensitivity potential of the test substance, following epicutaneous induction with 5% test substance concentrations to 53 healthy volunteers for 24 h under a semi-occlusive conditions. After a rest period of ca. 2 weeks, the substance was applied under the same conditions to a new site as a challenge. A the end of 24 h, the semi-occluded patch is removed and the site is read for immediate response. Follow-up readings are made 24 and 72 h later. The skin effects are then scored for irriation (erythema, edema as well as other irritation signs).
- GLP compliance:
- yes
- Remarks:
- ICH Guideline E6 for Good Clinical Practice (GCP) and 21CFR part 50 and 56 compliant
- Type of study:
- patch test
- Justification for non-LLNA method:
- - Human study
Test material
- Reference substance name:
- Alcohols, C16-18 and ethoxylated C16-18 , phosphates (20 moles ethoxylation)
- Molecular formula:
- C18H39O4P1 (monoester representative, i.e., mono- C18 PSE) C56H115O24P1 (ethoxylated monoester representative, i.e., mono- C16 AE20 PSE) C32H67O4P1 (diester representative, i.e., di- C18 PSE) C112H227O44P1 (ethoxylated diester representative, i.e., di- C16 AE20 PSE)
- IUPAC Name:
- Alcohols, C16-18 and ethoxylated C16-18 , phosphates (20 moles ethoxylation)
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human, healthy volunteers
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.2 mL (5% solution)
- Day(s)/duration:
- application of 24 hours on 3 different days for three weeks
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.2 mL (5% solution)
- Day(s)/duration:
- 24 hours, then follow-up readings (at 24 and 72 h)
- Adequacy of challenge:
- other: sensitisation responses on an adjacent virgin test site
- No. of animals per dose:
- 53
- Details on study design:
- In the induction phase, 0.2 mL test substance preparation (5%) was applied epicutaneously on 53 healthy volunteers for 24 h under an semiocclusive type of coverage. The applications were done daily on Monday, Tuesday and Friday for 3 consecutive weeks. After a rest period of ca. 2 weeks, the test substance was applied with the same conditions on a new site as a challenge. A the end of 24 h, the semi-occluded patch was removed and the site was read for immediate response. Follow-up readings were made 24 and 72 h later. The skin effects were then scored for irriation (erythema, edema as well as other irritation signs).
- Challenge controls:
- -
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- -
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 mL of a 5% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.2 mL of a 5% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 53
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified based on EU CLP criteria
- Conclusions:
- Under the study conditions, the test substance was not considered as a human skin sensitizer (semi-occlusive patch test).
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance, mono- and di- C16-18 PSE and C16-18 AE20 PSE’ using human repeated insult patch test (HRIPT), in compliance with ICH Guideline E6 for Good Clinical Practice (GCP) and 21CFR part 50 and 56. In the induction phase, a 5% test substance preparation was applied epicutaneously 3 times weekly to 53 healthy volunteers for 24 h under a semi-occlusive conditions. After a rest period of ca. 2 weeks, the substance was applied under the same conditions to a new site as a challenge. At the end of 24 h, the semi-occluded patch was removed and the site was read for immediate response. Follow-up readings were made 24 and 72 h later. The skin effects were then scored for irriation (erythema, edema as well as other irritation signs). No visible irritation was observed in any of the 53 individuals following challenge. Under the study conditions, the test substance was not considered to be sensitising to the human skin at 5% test concentration (CPT, 2001).
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