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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: Weight of evidence analysis based on expert reviews 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”.
To assess the genotoxicity of the substance, the toxicity of propane-1,2-diol ester of fatty acids and fatty acids in general is therefore considered. As supplementary data, also studies reviewed on propane-1,2-diol is included. As propane-1,2-diol is a major component of the substance and as the substance contains fatty acids, read-across to data on these substances is considered acceptable for the present substance. In general, data on propane-1,2-diol ester of fatty acids (EFSA 2018a) and fatty acids (CIR 2019) will be used.
A weight of evidence document is attached. The conclusion in this document is based on data from the following expert assessments:
CIR (2015). Safety Assessment of Propylene Glycol Esters as Used in Cosmetics, Final Amended report, January 15, 2015.
CIR (2019). Safety Assessment of Fatty Acids & Fatty Acid Salts as Used in Cosmetics, Tentative Report for Public Commenting, January 4, 2019
EFSA (2018a). Re-evaluation of propane-1,2-diol esters of fatty acids (E 477) as a food additive EFSA Panel on Food Additives and Flavourings (FAF). EFSA Journal 2018;16(12):5497.
EFSA (2018b). Re-evaluation of propane-1,2-diol (E 1520) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2018;16(4):5235
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:
- In relation to the data requirements of REACH VIII (10-100 t/y), data on genetic toxicity must be provided. Detailed study reports on this endpoint is not available for Stearic acid, monoester with propane-1,2-diol (PGMS), however data on PGMS in expert reviews are available.
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 genetic 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 acids (CIR 2019).
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. - Type of assay:
- bacterial reverse mutation assay
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
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- The gene mutation in bacteria (OECD 471) of Stearic acid, monoester with propane-1,2-diol (PGMS) was evaluated in a weight of evidence approach based on the studies available from expert evaluations of PGMS, propane-1,2-diol esters of fatty acids, fatty acids in general and propane-1,2-diol (EFSA 2018a; EFSA 2018b, CIR 2019). Negative results were obtained and a lack of mutagenic/ genotoxic potential is concluded for PGMS.
- Executive summary:
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%).
Limited studies on genotoxicity are available for Stearic acid, monoester with propane-1,2-diol (PGMS). Data were therefore also obtained for propane-1,2-diol esters of fatty acids, fatty acids in general and propane-1,2-diol in a weight of evidence approach. Propane-1,2-diol esters of fatty acids as well as propane-1,2-diol were evaluated as a food additive by EFSA in 2018 (EFSA 2018 a, b) and fatty acids was evaluated for the use in cosmetics by CIR in 2019 (CIR 2919).
Regarding gene mutation in bacteria, studies with bacterial reverse mutation assay (Ames) is described for PGMS, propane-1,2-diol esters of fatty acids, stearate fatty acids and propane-1,2-diol. Tests were performed in Salmonella Typhimurium strains TA100, TA1535, TA1537, TA98, TA1538 and Escherichia coli WP2uvrA (except for propane.1,2 diol, where data on E. coli WP2 is missing) with data comparable to current standards (OECD Guideline 471). Negative results were obtained in all studies with and without addition of S9 mix (EFSA 2018a; EFSA 2018b, CIR 2019).
All expert evaluations conclude no concern for genotoxicity for the evaluated compounds (EFSA 2018a; EFSA 2018b, CIR 2019). Thus, based on the studies available for PGMS, propane-1,2-diol esters of fatty acids, fatty acids in general and propane-1,2-diol, a lack of mutagenic/ genotoxic potential is concluded for PGMS, using a weight of evidence approach.
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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