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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 618-312-6 | CAS number: 898566-17-1
- 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
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Solubility in organic solvents / fat solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- solubility in organic solvents / fat solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 October 2015 - 21 October 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Indication of solubility in propylene glycol based on experiments in view of the development and validation of an analytical method for the analysis of the test item in propylene glycol.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- For the development and validation of an analytical method for analysis of the test item in propylene glycol, the following guideline was followed: EC guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex VII (Part A, section 4) and Annex III (Part A, section 5) of Directive 91/414, SANCO/3029/99 rev. 4 (11/07/00). No specific guidelines were followed for determination of the solubility of the test item in propylene glycol.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch: M14KB4863
Stable under storage conditions until 10 November 2017 (retest date)
Storage conditions: at room temperature - Key result
- Medium:
- other: propylene glycol
- Solubility:
- >= 207 g/L
- Test substance stable:
- yes
- Details on results:
- Analysis of formulations at 1 mg/mL (low) and 200 mg/mL (high) after storage yielded a relative difference of <= 10%. Based on this, the formulations were found to be stable during storage at room temperature under normal laboratory light conditions for at least 6 hours.
- Conclusions:
- Based on experiments performed in view of the development and validation of an analytical method for the test item in propylene glycol, the solubility of the test item in propylene glycol can be concluded to be >= 207 g/L. The test item proved to be stable in propylene glycol during storage at room temperature under normal laboratory light conditions for at least 6 hours.
Reference
Description of key information
Based on experiments performed in view of the development and validation of an analytical method for the test item in propylene glycol, the solubility of the test item in propylene glycol can be concluded to be >= 207 g/L. The test item proved to be stable in propylene glycol during storage at room temperature under normal laboratory light conditions for at least 6 hours (Brekelmans, 2016).
Key value for chemical safety assessment
Additional information
In view of the preparation of dose formulations for toxicity testing, trial preparations were prepared using a series of vehicles. As soon as a suitable vehicle is found, no further trial preparations are prepared. Propylene glycol was found to be a suitable vehicle, however, it was also reported that the substance did not dissolve in a 1% aqueous carboxymethyl cellulose solution (see study report of Latour (2016) on acute dermal toxicity testing). Next to this solution and propylene glycol, no other solvents were tested.
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.
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