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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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-07-20 until 1987-07-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No OECD guideline available at the time the study was performed. Nevertheless the study is similar (with deviations) to OECD guideline 428, scientifically acceptable with some reporting deficiences
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Version / remarks:
- 13 April 2004
- Deviations:
- yes
- Remarks:
- deviations in absorption period, dose applied lower than 10 µL/cm², only one concentration applied.
- GLP compliance:
- no
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:
- other: solution
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- other: In this in vitro study, skin from naked rats and pigs was used.
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- ethanol
- Remarks:
- 30 %
- Duration of exposure:
- 1, 6, 16 hours
- Doses:
- 6 µL/cm² equivalent to 300 µg active substance / cm² (the test substance was formulated to yield a concentration of 5% in ethanol (30%)).
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: skin from naked rats and pigs
- Preparative technique:
Active substance prepared 1-5 µCi/ 5 cm² skin site.
Excision of the skin – the skin was separated from fresh operation material. The coonective and adipose tissue is carefully removed and then the skin is separated into round flaps of ca. 20 cm². Every piece was cleaned under floating water, and thereafter is either used directly for the experiment or stored in aluminium foil at -20°C.
Preparation of the excised skin – the skin specimen were marked with areas of 5 cm². 30 µL of the test substance were applied regularly with micropipette on the marked areas. The skin specimen were clamped into the penetration chambers. The lower part of the prepared skin was in constant contact with physiological salt solution, which was slightly moved by a magnetic stirrer throughout the whole experiment (1, 6, 16 hours).
PRINCIPLES OF ASSAY
- Diffusion cell: yes
- Receptor fluid: 0.9 % (w/v) NaCl (continuously stirred)
- Static system: yes
- Test temperature: 32°C
- Occlusion: not specified
- Other: The measurement of activity was carried out with a Packard liquid scintillation spectometer
Results and discussion
- Absorption in different matrices:
- Most of the radioactivity could be washed off. Minor amounts of radioactivity could be recovered from stratum corneum, epidermis, dermis and receptor fluid. Mean levels of expressed as µg/cm² are presented in a table below in "any othe information on results"
- Total recovery:
- - Total recovery: naked rat skin or pig skin - 300 µg/cm²
Most of the radioactivity could be washed-off from stratum corneum.
Percutaneous absorption
- Key result
- Dose:
- 6 µL/cm²
- Parameter:
- percentage
- Absorption:
- > 5.2 - < 9 %
- Remarks on result:
- other: 1 - 16 hours
- Remarks:
- mean penetration percent in naked rat and pig skin
Any other information on results incl. tables
|
|
Naked rat skin |
|
µg/cm2in |
|
Contact time |
|
|
1h |
6h |
16h |
skin wipe |
261.98 |
235.37 |
181.14 |
Horny layer |
22.44 |
37.37 |
99.25 |
Remaining skin tissue layers |
15.58 |
23.85 |
12.44 |
Chamber liquid |
-- |
3.41 |
7.17 |
Total recovery |
300 |
300 |
300 |
Systemic available[1] |
15.6 |
27.3 |
19.61 |
Systemic available[2](%) |
5.2 |
9.0 |
6.5 |
|
|
Pig skin |
|
skin wipe |
269.13 |
262.52 |
218.19 |
Horny layer |
13.93 |
13.97 |
56.02 |
Remaining skin tissue layers |
16.94 |
20.34 |
19.96 |
Chamber liquid |
-- |
3.17 |
5.83 |
Total recovery |
300 |
300 |
300 |
Systemic available |
16.94 |
23.51 |
25.79 |
Systemic available (%) |
5.6 |
7.9 |
8.6 |
[1]Amount in skin (without horny layer) and receptor fluid
[2]Calculated based on applied active substance (300 µg/cm2)
Applicant's summary and conclusion
- Conclusions:
- The test substance (14C-Amphisol) penetrates into skin. Overall, mean penetration was between 5.2 % and 9.0 %. Most of the radioactivity could be washed-off from stratum corneum.
- Executive summary:
The in-vitro percutaneous penetration of the test substance was determined using skin from naked rat or pig (thickness not indicated). The penetration was investigated in a static system. The test substance was formulated to yield a concentration of 5% in ethanol (30%). The formulations were applied at dose levels of 6 µL per cm2 (equivalent to 300 µg per cm²) at a temperature of 32°C. Occlusion conditions not specified. Skin integrity testing if performed was not reported.
The penetration of the test substance was determined over 1, 6, and 16 h. After respective contact duration, the skin was wiped with cotton wool, the horny layer was removed by tape stripping. The total radioactivity was determined in all samples (skin wipe, tape strips, remaining skin, receptor fluid, chamber) collected by means of liquid scintillation counting.
Most of the radioactivity could be washed off. Minor amounts of radioactivity could be recovered from stratum corneum, epidermis, dermis and receptor fluid. Based on the radioactivity found in remaining skin and receptor fluid the amount of the test substance absorbed represented between 5.2 – 9.0 %. This corresponds to 15.6 – 27.3 µg test substance equivalents/cm2. Exposure time and type of skin showed no real influence on penetration rate.
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