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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: weight of evidence analysis based on expert evaluated data on hydrolysis products and structural analogues
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: based on expert group reviews
- Justification for type of information:
- PGMS is manufactured by a reaction between stearic acid and propylene glycol. The UVCB substance belongs to the group of fatty acid esters. Within this group is the group of polyglycerol fatty acid esters, which are commonly used in cosmetics and as food ingredients representing substances composed of chemical units of similar structure as the fatty acid esters with propylene glycol. The polyglycerol fatty acids are esters of fatty acids and units of glycerol. The glycerol units represent the propylene glycol in “Stearic acid, monoester with propane-1,2-diol”.
Stearic acid, monoester with propane-1,2-diol (PGMS) is a UVCB substance. The two main constituents of the UVCB substance are the monoester of propane-diol with octadecanoic acid (45-98%) and the monoester of propane-diol with palmitic acid (2-50%). The possible acute oral toxicity of this substance is therefore assessed in the present weight of evidence analysis based on existing data on propane-1,2-diol esters of fatty acids including PGMS (EFSA 2018a) and the relevant hydrolysis products propane-1,2-diol (EFSA 2018b) and fatty propylene glycol stearate (PGS) and glycerol stearate (CIR 2015; 2016).
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
- Principles of method if other than guideline:
- The results are based on a weight of evidence analysis from collection of studies extracted from the literature. For more details please refer to the attached weight of evidence document.
In relation to the data requirements of REACH Annex VIII (10-100 t/y), data on acute oral toxicity must be provided. Limited data on this endpoint is available for Stearic acid, monoester with propane-1,2-diol (PGMS). The possible acute oral toxicity of this UVCB substance is therefore assessed in the present weight of evidence analysis based on existing data on propane-1,2-diol esters as well as the relevant hydrolysis products and the components in the UVCB substance.
Metabolism studies of propane-1,2-diol esters of stearate show that the substances are partially hydrolysed by pancreatic lipase; approx. 70% in 15 h. As the passage through the small intestine has a duration of 6–8 h, unhydrolyzed propane-1,2-diol esters of stearate will be present in the gastrointestinal tract for absorption (EFSA 2018a).
The possible acute oral toxicity of this substance is therefore assessed in the present weight of evidence analysis based on existing data on propane-1,2-diol esters of fatty acids including PGMS (EFSA 2018a) and the relevant hydrolysis products propane-1,2-diol (EFSA 2018b) and fatty propylene glycol stearate (PGS) and glycerol stearate (CIR 2015; 2016).
As the substance is an UVCB-substance and as expert group assessments of the components in the substances are considered the most valid data for the assessment, an overall weight of evidence approach based on these expert evaluations is used for the assessment. - GLP compliance:
- not specified
- Remarks:
- Data extracted from expert opinions
Test material
- Reference substance name:
- Stearic acid, monoester with propane-1,2-diol
- EC Number:
- 215-354-3
- EC Name:
- Stearic acid, monoester with propane-1,2-diol
- Cas Number:
- 1323-39-3
- Molecular formula:
- C21H42O3
- IUPAC Name:
- 2-hydroxypropyl stearate
- Test material form:
- solid: pellets
1
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the studies available for Stearic acid, monoester with propane-1,2-diol (PGMS) and the relevant hydrolysis products and the components of the UVCB substance, it can with a high degree of confidence be concluded that an assumed acute oral lethal dose 50 (LD50) for PGMS is above 10000 mg/kg, and well above 5000 mg/kg which is normally considered as the highest relevant dose level when testing acute toxicity. Thus, PGMS is not to be classified for acute oral toxicity. Overall, available information comprises adequate, reliable studies from
reference substances with similar structure and intrinsic properties. Using data
from comparable substances is justified based on common functional group,
common precursors/breakdown products. The information from these
independent sources is consistent and provides sufficient weight of evidence
leading to an endpoint conclusion in accordance with Annex XI, 1.2, of
Regulation (EC) No 1907/2006. - Executive summary:
Detailed study reports on this endpoint are not available for Stearic acid, monoester with propane-1,2-diol (PGMS), however data on PGMS in expert reviews are available. Further, existing data on propylene glycol stearate (PGS) and glyceryl stearate (GS) (CIR 2015; 2016) was used as support in this weight of evidence evaluation.
The LD50 of PGMS from acute oral toxicity studies performed in rats ranges from > 2.7 – 25.8 g/kg bw. In all studies, at ≤ 10 g/kg, no mortality is reported. The only study where mortality was reported, was in the study (number 3 described), where doses up to 32 g/kg was tested. It is also in this study, where the highest LD50-value (25.8 g/kg) was found (EFSA 2018a). The acute oral toxicity of PGMS is therefore considered to have low toxicity and to be above the doses used for classification.
This was also the conclusion form the EFSA evaluation on propane 1,2-diol (EFSA 2018b), stating that overall, the acute toxicity for propanediol-1,2-diol was low. Supportive of this, low acute oral toxicity of the hydrolysis products PGS and GS was also reported in CIR expert reviews, with LD50 > 25.8 g/kg bw for PGS (CIR 2015) and LD50 > 5 g/kg bw for GS (CIR 2016), respectively. Further, it is noted that PGS and GS are considered Generally Recognized as Safe (GRAS) for food use (CIR 2015; 2016).
The overall conclusion is therefore that PGMS has low acute oral toxicity with LD50-values well above the highest dose used for classification as acute toxicity (i.e., 2000- 5000 mg/kg). Hence, low toxicity and no need for classification is concluded for Stearic acid, monoester with propane-1,2-diol (PGMS).
Overall, available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. Using data from comparable substances is justified based on common functional group, common precursors/breakdown products. The information from these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006.
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.
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