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Diss Factsheets
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EC number: 222-581-1 | CAS number: 3539-43-3
- 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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Although one bacterial gene mutation study resulted in some positive findings in some strains, these responses were typically weak (although statistically significant) and were not always treatment-level related. It is also noted that some strains consistently showed greater cytotoxicity than other strains.
An effect was seen in a related substance that led to high toxicity to TA100, but has not been seen in other similar alkyl phosphate substances when bacterial gene mutation testing was performed. None of the assessed fatty alkyl phosphates resulted in positive mutagenic potential.
The potassium salt has been tested at the same time in the same laboratory and no mutagenic potential has been noted and although some toxicity at highest concentrations in some strains, the anomalies were minimal compared to the non-potassium form
A review of higher-level testing on similar substances suggests that this class of substance is non-mutagenic in mammalian test systems.
It is concluded that the adverse effects seen are not fully consistent with other similar substances. None of the other substance showed mutagenic potential and as a result, the substance can be considered as not being potentially mutagenic itself.
Link to relevant study records
- Endpoint:
- genetic toxicity in vitro, other
- Remarks:
- Review of different endpoints
- Type of information:
- experimental study
- Remarks:
- Based on experimental work
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of data on the substance itself, the potassium salt and other alkylphosphates
- GLP compliance:
- not specified
- Type of assay:
- other: Review of various test types
- Specific details on test material used for the study:
- The substanxce to be registred was assessed; this included comparison with similar alkyl phosphates
- Target gene:
- Bacterial and mammalian cells examined
- Metabolic activation:
- with and without
- Metabolic activation system:
- Studies reviewd were with or without S-9 fraction
- Species / strain:
- other: All assays
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Typcially tested to limits of toxicity
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Conclusions:
- From review of various test types for substances in this class, there is no evidence that the substance a potential mutagen.
- Executive summary:
The CIR review and other less thorough summaries seen all indicate that this class of substance is not considered to have mutagenic potential. With the exception of one of the bacterial gene mutation assays, toxicity to the cultures was not remarkable; in all mammalian cultures, the top test concentrations typically led to toxicity, but this is a requirement of the guidelines to test to levels leading to toxicity or precipitation.
Some of the bacterial studies reported toxicity at maximum concentration and most showed consistency between strains and whether with or without S9 activation.
Reference
The potassium salt resulted in some toxicity for TA1535, TA 98 and TA100 (TA100 and TA98 were repeated at lower levels and all were negative). And although a slight elevation in revertants in some replicates, only one showed a statistically significant increase. The assay is considered 'negative' in its assessment.
A major review has been undertaken by the Cosmetic Ingredient Review committee, with a publication from 2014 providing a good review of safety.
Primary data sources are cited in this review and where publically available (eg through primary publications or from REACH Registration dossiers that also cited these tests), checks were made to look for further details. The objective of looking deeper into the data was to assess whether there are anomalies in the data sets as seen in the Bacterial Gene Mutation assay performed on the substance in 2019.
It should also be noted that the CIR committee justified that these fatty-alkyl phosphates and their potassium salt could be considered collectively as a review of the whole group meaning that read-across / grouping can be justified as valid.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
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.