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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
Endpoint summary
Administrative data
Description of key information
Acute toxicity after single oral application was tested in rats, which received 16000 mg/kg bw/d. All animals survived until the end of the study without showing any signs of systemic toxicity. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed. The LD50 value for acute oral toxicity is > 16000 mg/kg bw.
A single dermal application of Dihexadecyl hydrogen phosphate to 20 rats (10 males and 10 females) at a dose of 2000 mg/kg bw was associated with no mortality and neither signs of irritation. The dermal LD50 was determined to be > 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug - Sept 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP conform study with design equivalent to guideline; sufficient reporting
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, England
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 109 - 150 g
- Fasting before dosing: overnight prior to and approx. 4 h after dosing
- Housing: in groups by sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard laboratory rodent diet (Labsure LAD 1), ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: min. 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): 62%
- Air changes (per hr): approx. 15/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30.8. To: 13.9.1985 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 80% (w/v)
- Amount of vehicle (if gavage): 20 mL/kg - Doses:
- 16000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed soon after dosing; then at frequent intervals for the remainder of day 1. On subsequent days the animals were observed at least once in the morning and once at the end of the experimental day. Individual body weights were taken on days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (see above), body weight (see above) - Statistics:
- none
- Preliminary study:
- A trial test was carried out by dosing two male and two female rats at 16000 mg/kg bw. The results of the preliminary study indicated that the acute median lethal oral dose of the test item was in excess of 16000 mg/kg bw.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Mortality:
- no mortalities occurred.
- Clinical signs:
- other: Piloerection only was observed in the rats treated at 16000 mg/kg bw with the test substance. A similar reaction was not seen in control animals. Recovery of test animals as judged by external appearance and behaviour was apparently complete by day 3.
- Gross pathology:
- No effects
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The median lethal dose of Dihexadecyl hydrogen phosphate (LD50) greater than 16000 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification requirements according to regulatory requirements.
- Executive summary:
Dihexadecyl hydrogen phosphate was tested for its acute toxic properties in rats via oral route. No animal died or showed clinical symptoms/macroscopic anomalies after application of 16000 mg/kg bw.
Therefore, the median lethal dose of Dihexadecyl hydrogen phosphate (LD50) was greater than 16000 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 16 000 mg/kg bw
- Quality of whole database:
- 1 (reliable without restrictions)
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug - Sept 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP conform study, equivalent to guideline; sufficient reporting
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, England
- Age at study initiation: 8 -11 weeks
- Weight at study initiation: 200 - 256 g
- Housing: indivividually in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard laboratory diet (Labsure LAD 1), ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 63%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 21.8. To: 4.9.1985 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5x5 cm
- % coverage: 100%
- Type of wrap if used: The treated area was covered with gauze which was held in place with an impermeable dressing encircled firmly around the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (40-40°C) and blotted dry with absorbent paper
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (as 80% (w/v) paste in distilled water
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 2.5 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed soon after dosing; then at frequent intervals for the remainder of day1. On subsequent days the animals were observed at least once in the morning and once at the end of the experimental day. Individual body weights of rats were mearsured on days 1, 4, 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
other: Treated areas of skin were examined daily for signs of dermal irritation and assessed. - Statistics:
- none
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: No signs of toxicity observed.
- Gross pathology:
- No effects
- Other findings:
- No dermal reactions.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation.The dermal LD50 was determined to be > 2000 mg / kg body weight.
- Executive summary:
Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation.The dermal LD50 was determined to be > 2000 mg / kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 1 (reliable without restrictions)
Additional information
Based on the results of
an oral toxicity study and an acute dermal toxicity study the LD50values
for acute oral and dermal toxicity was determined to be > 16000 and >
2000mg/kg bw, respectively.
In
accordance with REACH “Column 2” in Annex VIII there is sufficient
weight of evidence from several independent sources of information
leading to the conclusion that Reaction mass of dihexadecyl hydrogen
phosphate and hexadecyl dihydrogen phosphate does not exert systemic
toxic effects after acute inhalation exposure and thus does not have to
be classified, because
- the LD50 value for acute oral toxicity of Dihexadecyl hydrogen phosphate is > 16000 mg/kg bw,
- the LD50 value for acute dermal toxicity of Dihexadecyl hydrogen phosphate is > 2000 mg/kg bw and
- inhalation is very unlikely to occur, taking into account the physical state of the substance.
Therefore, and for animal welfare reasons, it is concluded that testing of acute inhalation toxicity of Reaction mass of dihexadecyl hydrogen phosphate and hexadecyl dihydrogen phosphate is not scientifically necessary.Justification for selection of acute toxicity – oral endpoint
GLP conform study with design equivalent to guideline; sufficient reporting
Justification for selection of acute toxicity – inhalation endpoint
n.a.
Justification for selection of acute toxicity – dermal endpoint
GLP conform study, equivalent to guideline; sufficient reporting
Justification for classification or non-classification
Due to the results described in the acute oral and dermal toxicity studies (LD50oral/dermal in rats > 16000 and > 2000 mg/kg bw, respectively)Reaction mass of dihexadecyl hydrogen phosphate and hexadecyl dihydrogen phosphatedoes not have to be classified as acute orally and dermally toxic. Based on the substance's physico-chemical properties no higher systemically exposure via inhalation is expected to occur than that tested in the course of the oral and dermal toxicity studies. Therefore,Reaction mass of dihexadecyl hydrogen phosphate and hexadecyl dihydrogen phosphatedoes not have to be classified as acute toxic.
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