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EC number: 242-768-1 | CAS number: 19035-79-1
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1988-06-29 until 1988-08-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Males and females participants ranging in age from 25 to 65 years are empaneled for the test. The amount applied of test material to each test patch unit is approximately 0.2 mL applied in an occlusive manner. The induction phase includes 9 subsequent applications with a rest period of 24 hours (2 times in a week and 48 hours (1 time per week). Same application site is used for all 9 applications unless a positive reaction of a 2 – level erythema appears, than a new application site is used. When a 2 – level erythema appears in the new site, no further applications would be made. After a rest period of 10 to 21 days, the Challenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Potassium hexadecyl hydrogen phosphate
- EC Number:
- 242-768-1
- EC Name:
- Potassium hexadecyl hydrogen phosphate
- Cas Number:
- 19035-79-1
- Molecular formula:
- C16H35O4P.K
- IUPAC Name:
- potassium hexadecyl hydrogen phosphate
- Test material form:
- liquid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Controls:
- Not applicable
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: Minimal, faint, uniform or spotty erythema. By one participant during the induction phase only and by the other during the challenge phase.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 2 / 53
- Number of subjects with negative reactions: 51 / 53
Any other information on results incl. tables
A total of 53 subjects satisfactorily completed the test procedure (one (1) subject discontinued for personal reasons unrelated to the conduct of the study). Scattered, transient, barely perceptible (+) non-specific patch test responses were observed on 2/53 test panelists during the induction or challenge phases of the study. One of these 2 subjects was unable to report to the clinic at 72-hrs., but verbally stated that the (+) reaction had disappeared at 72-hrs. Based on this report, neither of these non-specific responses were considered to be irritant or allergic in nature.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of a repeated insult (occlusive) patch test procedure. The test substance (6 %) did not induce irritant or allergic contact dermatitis in human subjects.
- Executive summary:
A total of 54 subjects, 14 males and 40 females, ranging in age from 25 to 65 years were empaneled for irritation / sensitisation test. The subjects were informed of the nature of the test, including possible adverse reactions. Written informed consent was obtained.
9 Repeated Insult (occlusive) Patch Test (9 RIPT) of the test substance (6 %) was conducted as follows:
Induction Phase
The Induction Phase was initiated on: June 29, 1988.
The amount of test material applied to each test patch unit was approximately 0.2 mL.
The test material was placed onto a Parke-Davis Readi-Bandage(R) occlusive patch, which was applied to the back of each subject between the scapulae and waist, adjacent to the spinal mid-line.
The subjects removed the patch 24 hours after application. Twenty-four hour rest periods followed the Tuesday and Thursday removals and 48-hour rest periods followed the Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated every Monday, Wednesday and Friday until nine (9) applications of the test material had been made.
Procedurally, if a subject develops a positive reaction of a 2-level erythema or greater during the Induction phase or, at the discretion of the Study Director, if the skin response warranted a change in site, the patch would be applied to a previously unpatched, adjacent site for the next application. If a 2-level reaction (or greater) occurred on the new site, no further applications would be made. However, any reactive subjects would be subsequently challenge patched with the test material.
Challenge Phase
After a rest period of 10 to 21 days (no further application of the test material), the Challenge patch was applied to a previously unpatched (virgin) site. The site was scored 24 and 48 hours after application. The panelists were asked to report to the laboratory any delayed reaction which might have occurred after the last reading.
A total of 53 subjects satisfactorily completed the test procedure. One subject discontinued for personal reasons unrelated to the conduct of the study. Discontinued panelist data are shown up to the point of discontinuation, but are not used in the Results, Discussion or Conclusions sections of this final report.
Scattered, transient, barely perceptible (assigned as +, see in "any other information on materials and methods) non-specific patch test responses were observed on 2/53 test panelists during the Induction or Challenge phases of the study. One of the two panelists was unable to report to the clinic at 72-hrs., but verbally stated that the (+) reaction had disappeared at 72-hrs.
Based on this report, neither of these non-specific responses were considered to be irritant or allergic in nature.
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