Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Study period:
- After approval by ECHA
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
Potassium hexadecyl hydrogen phosphate, CAS 19035-79-1
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : No developmental toxicity study with CAS 19035-79-1 is available
- Available non-GLP studies : No developmental toxicity study with CAS 19035-79-1 is available
- Historical human data : The applicant is not aware of human data for developmental toxicity. The product is on the market since decades and used as emulsifier in personal care products up to 10%. In the Cosmetic Ingredient Review (CIR) on Alkyl Phosphates (Cetyl Phosphates is an analogue of CAS 19035-79-1 and belongs to this group of compounds) such information could not be found. (CIR, Safety Assessment of Alkyl Phosphates as Used in Cosmetics, 29-September-2014, see attachment)
- (Q)SAR : Derek Nexus does not fire an alert for teratogenicity / developmental toxicity (see attached file). This QSAR calculation is not sufficient to cover the developmental toxicity endpoint.
- In vitro methods : No data for CAS 19035-79-1 available. In vitro methods require that the substance is solubilized in water. The water solubility is very low (0.198 g/L) and thus, testing in vitro is technically not possible.
- Weight of evidence : The available data / information in terms of QSAR and other substances (see CIR) suggest that CAS 19035-79-1 is unlikely to be teratogenic, embryotoxic. However, deriving quantitative information is not possible.
- Grouping and read-across : The CIR assessed recently the group of alkyl phosphates. CAS 19035-79-1 is a compound being similar to this group. The CIR concludes in terms of teratogenicity / embryotoxicity as follows: “Potassium C9-15 alkyl phosphate was not embryotoxic, fetotoxic, or teratogenic in rats dosed by gavage on days 6-15 of gestation; the NOELs for developmental toxicity, embryotoxicity, fetotoxicity, and teratogenicity were 361 mg/kg bw/day (a.i.), and the NOEL and NOAEL for maternal toxicity were 36.1 and 361 mg/ kg bw/day (a.i.), respectively.” This substance differs from CAS 19035-79-1 in the chain length and in addition, the NOAEL for maternal toxicity is much lower than the NOAEL of 800 mg/kg bw/d for CAS 19035-79-1 derived from a 90-day study. The relevance for such data is therefore questionable.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Annex IX Column 2 specific rules for adaptation for this endpoint are not applicable for the registered substance
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
OECD 414 study in rats via oral gavage. Test substance will be given as suspension to the animals. Dose levels will be selected based on a dose-range-finding experiment. The range-finding experiment is necessary in consideration of the available hazard information (eye irritation) which may complicate the main study.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
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:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.