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Diss Factsheets
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EC number: 215-354-3 | CAS number: 1323-39-3
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- other: Weight of evidence
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- No data are available for "Stearic acid, monoester with propane-1,2-diol". The bioaccumulation of this substance is therefore assessed in a weight of evidence analysis on the basis of calculation
of the BCF of the components in the substance.
As the substance is composed of different components and as expert group assessments
of the components in the substances are considered the most valid method for the
assessment, an overall weight of evidence approach is used for the assessment. - Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The bioaccumulation of this substance is derived on the basis of a weight of evidence analysis due to calculations of the BCF of the components in the substance.
- GLP compliance:
- no
- Key result
- Temp.:
- ca. 25 °C
- pH:
- 7
- Type:
- BCF
- Value:
- > 200 dimensionless
- Basis:
- whole body d.w.
- Calculation basis:
- steady state
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Based on a weight-of-evidence approach it is concluded that the compound “Stearic acid, monoester with propane-1,2-diol” has a BCF below 200.
- Executive summary:
Data on this endpoint are not available for “Stearic acid, monoester with propane-1,2-diol”. The bioaccumulation of this substance is therefore assessed in the present weight of evidence analysis on the basis of calculation
of the BCF of the components in the substance. As the substance is composed of different components and as expert group assessments of the components in the substances are considered the most valid method for the assessment, an overall weight of evidence approach is used for the assessment.Within this group is the group of polyglycerol fatty acid esters, which are commonly used “Stearic acid, monoester with propane-1,2-diol” is an UVCB substance. BCFBAF calculations on all identified constituents in the UVCB substance resulted in a BCF between 3 and 515 with a concentration averaged BCF well below 500. Based on a weight-of-evidence approach it is concluded that the compound “Stearic acid, monoester with propane-1,2-diol” has a BCF below 200.
Reference
Description of key information
Test data on bioaccumulation (BCF) is not available for “Stearic acid, monoester with propane-1,2-diol” (PGMS). The bioaccumulation of this substance is therefore assessed based on a weight of evidence analysis of the BCF of the components in the substance and their major metabolites.
The two main constituents of the UVCB substance are both monoester of propane-diol with octadecanoic acid (45-98%) and the monoester of propane-diol with palmitic acid (2-50%). Thus, the UVCB substance belongs to the group of fatty acid esters and has a very similar structure to the well-known monoglycerides – the only exception being the lack of a OH-group on the C3-carbon in the propylene glycol. The group of monoglycerides is well recognised as having a low potential for bioaccumulation due to their readily metabolism primarily into glycerol and the fatty acid – the latter readily being metabolised via the common mechanism of β-oxidation. The UVCB substance is assessed to be metabolised in the same manner as the monoglycerides via the formation of the fatty acid and the propylene glycol.
Therefore, based on a weight of evidence approach, the substance is concluded to have a low potential for bioaccumulation. The BCF values of the various components were calculated using BCFBAF v3.01 (EPI Suite v4.11), and it was concluded that the compound “Stearic acid, monoester with propane-1,2-diol” has a BCF below 200.
This weight-of-evidence-based conclusion on the low potential for bioaccumulation as for the monoglycerides is justified by their common functional groups, metabolism pathway and their common precursors/breakdown products. Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006.
Key value for chemical safety assessment
- BCF (aquatic species):
- 200 dimensionless
Additional information
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.