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EC number: 911-302-5 | 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:
- Feb - Apr 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP conform guideline study with sufficient reporting
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- 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
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Weight at study initiation: 400 -450 g
- Housing: in suspended cages with wire mesh floors
- Diet (e.g. ad libitum): Vitamin C enriched Guinea-pig Diet F.D.1., ad libitum; hay was given weekly
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 21°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approx. 15/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28.2. To: 1.4.1989
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction(intradermal):
0.5% (w/w)
Induction (topical):
40% (w/w)
1. Challenge:
40 and 20% (w/w)
2. Challenge:
10 and 1% (w/w)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction(intradermal):
0.5% (w/w)
Induction (topical):
40% (w/w)
1. Challenge:
40 and 20% (w/w)
2. Challenge:
10 and 1% (w/w)
- No. of animals per dose:
- Control animals: 10
Test animals: 20 - Details on study design:
- Induction phase:
- Intradermal injections
A 4x6 cm area of dorsal skin on the scapular region of the guinea-pig was clipped free. Three pairs of intradermal injections were made simultaneously.
Injections were prepared as follows:
1. Freund´s complete adjuvant was diluted with an equal volume of water for irrigation
2. Test item, 0.5% (w/w) in water for irrigation
3. Test item, 0.5% (w/w) in a 50:50 mixture of Freund´s complete adjuvant and water for irrigation
- Topical application
One week after the injections, the same 4x6 cm interscapular area was clipped and shaved free of hair. A 2x4 cm patch of Whatman No. 3 paper was saturated with the test item, 40% (w/w) in distilled water. The patch was placed on the skin and covered by length of impermeable plastic adhesive tape. This in turn was firmly secured by elastic adhesive bandage wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.
Control animals:
During the induction phase, the control animals were treated similarly to the test animlas with the exception that the test compound was omitted from the intradermal injections and topical applications.
Challenge phase:
The test and control animals were challenged topically two weeks after the induction period using the test item, 40% and 20% (w/w) in distilled water. Hair was removed by clipping and then shaving from an area on the left flank of each Guinea pig. A 2x2 cm patch of Whatman No. 3 paper was saturated with approx. 0.2 mL of the test item, 4% (w/w) in distilled water and applied to an anterior site on the flank. The test substance, 20% (w/w) in distilled water was applied in a similar manner to a posterior site. The patches were sealed to the flank 24 h under strips of "Blenderm" covered by "Elastoplast" wound round the trunk and secured with "Sleek".
Slight dermal reactions were observed in both test and control animals, therefore a second challenge application was made one week later using lower concentrations. The method employed was similar to that described above, with the exception that this occation the test item, 10% and 1% (w/w) in distilled water was applied to the right flank of all the test and control animals. - Challenge controls:
- The sensitivity of the Guinea pig strain is checked periodically with Formalin.
- Positive control substance(s):
- yes
- Remarks:
- Formalin
Results and discussion
- Positive control results:
- Formalin (0.1 % intradermal; 10 % epidermal applied)
- incidence after challenge: 10 of 10 animals positive
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1% (anterior site); 10% (posterior site)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects reported
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 1% (anterior site); 10% (posterior site). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects reported.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% (anterior site), 10% posterior site
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects reported
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1% (anterior site), 10% posterior site. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- In this Guinea pig maximisation test (according to Magnusson and Kligman) performed in 20 albino Guinea pigs Hexadecyl dihydrogen phosphate did not produce evidence of delayed contact hypersensitivity.
- Executive summary:
Testing for sensitising properties of Hexadecyl dihydrogen phosphate was performed in female guinea pigs according to the Guinea pig Maximisation Test. Intradermal induction was performed using 0.5 % Hexadecyl dihydrogen phosphate and the topical induction was conducted using 40% of the test item. The first challenge was carried out with 20% and 40% Hexadecyl dihydrogen phosphate (topical). Slight reactions were observed in both test and control animals. Therefore, one week after the first challenge and the second challenge was conducted with 1% and 10% test item.
There were no dermal reactions seen in any of the test or control animals following the second challenge application.
Hexadecyl dihydrogen phosphate is not a skin sensitiser.
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