Registration Dossier
Registration Dossier
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: 291-905-1 | CAS number: 90506-43-7
- 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
The oral LD50 female 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to attached document - Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 females was determined to be > 2000 mg/kg bw.
- Executive summary:
Acute oral toxicty data from 1-Octadecanol, phosphate, potassium salt were used to evaluate the acute oral toxicity for Phosphoric acid, C12-18-alkyl esters, potassium salts.
The acute oral toxicity in rats was determined using the Fixed Dose Procedure as recommended in the OECD Guideline No. 420.
In a sighting study, one female rat was given a single does of 2000 mg/kg bw 1-Octadecanol, phosphate, potassium salt. Slight signs of toxicosis (piloerection) were observed in this rat.
Based on the results from the sighting study, the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w. All animals in the main study survived the treatment, weight gain was normal and apart from piloerection no other clinical signs were observed. The gross necropsy of the animals revealed no pathological abnormalities.
The oral LD50 females was determined to be > 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Read-across from a study according to OECD 401 Guideline with GLP
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
Acute oral toxicty data from 1-Octadecanol, phosphate, potassium salt were used to evaluate the acute oral toxicity for Phosphoric acid, C12-18-alkyl esters, potassium salts.
The acute oral toxicity in rats was determined using the Fixed Dose Procedure as recommended in the OECD Guideline No. 420.
In a sighting study, one female rat was given a single doses of 2000 mg/kg bw 1-Octadecanol, phosphate, potassium salt. Slight signs of toxicosis (piloerection) were observed in this rat.
Based on the results from the sighting study, the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w. All animals in the main study survived the treatment, weight gain was normal and apart from piloerection no other clinical signs were observed. The gross necropsy of the animals revealed no pathological abnormalities.
The oral LD50 female was determined to be > 2000 mg/kg bw.
Acute inhalation toxicity
Testing on vertebrate animals for the purpose of REACH shall be undertaken only as a last resort.
Information from acute oral toxicity are available, a LD50 value of > 2000 mg/kg was established and no signs of toxicity were observed, thus the acute intrinsic toxicity is considered to be low.
Data from in-vitro skin and eye irritation studies indicate irritating properties of the substance.
Furthermore supporting information from a similar substance Phosphoric acid, C16-18-alkyl esters, potassium salts is available, supporting the low intrinsic toxicity. However, the tested limit dose is below the limit dose required by the guideline, therefore the study is considered not relevant for chemical safety assessment.
Considering the physico-chemical properties of the substance exposure of humans via inhalation is not likely. The vapour pressure of Phosphoric acid, C12-18-alkyl esters, potassium salts is very low (1.5E-6 Pa) and the substance is marketed as aqueous suspension. Furthermore, no industrial spraying, or generating of aerosols is expected during processing. Therefore no high peak exposure after inhalation exposure is expected. As a precautionary measure a DNEL for short term exposure after inhalation will be set based on long-term inhalation DNEL.
In conclusion, further testing on vertebrate animals for acute toxicity via inhalation route is scientifically not necessary, taken into account available information reflecting low acute intrinsic toxicity. As well exposure of humans via inhalation is not likely, taken into account physico-chemical properties and use description of the substance.
Acute dermal toxicity
The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity of STOT SE by the oral route. The LD50 is > 2000 mg/kg bw.
Justification for classification or non-classification
Based on relevant, reliable and adequate data,Phosphoric acid, C12-18-alkyl esters, potassium salts does not have to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to acute toxicity.
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.
