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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
Endpoint summary
Administrative data
Description of key information
No studies are available for Stearic acid, monoester with propane-1,2-diol (PGMS). Data were therefore obtained for the group of propylene glycol stearate (PGS), the relevant hydrolysis products and structural analogues. PGMS and PGS are both UVCB substances, formed by esterification of propane-1,2-diol and stearic acid (and to a lesser extent palmitic acid) but PGS has a higher diester content and lower monoester content than PGMS. The UVCB substance belongs to the group of PGS, which are commonly used in cosmetics and as food ingredients (CIR 1983 and CIR 2015).
In order to assess the skin sensitisation potential of PGMS, the toxicity of PGS in general is therefore considered. Based on the data on PGS, the close similarity between PGS and PGMS and the identical QSAR predictions for the skin sensitisation potential of PGS and PGMS it can by weight of evidence be concluded that the data is considered acceptable for the present substance.
A limited study in two guinea pigs using intracutaneous injections of 0.1% (PGS) did not result in sensitisation. Further, clinical testing of cosmetic formulations containing PGS in a concentration of 1.5-2.5% did not result in any cases of sensitisation among 4984 subjects suggesting a lack of skin sensitising properties. Danish QSAR database predictions of propylene glycol monostearate further indicate lack of a skin sensitising properties. Also, in relation to the primary starting materials and possible product of hydrolysis of PGMS, propane-1,2-diol and stearic acid, there is no concern for skin sensitising properties according to experimental animal data for propane-1,2-diol and according to QSAR predictions for stearic acid.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- 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:
- No studies are available for Stearic acid, monoester with propane-1,2-diol (PGMS). Data were therefore obtained for the group of propylene glycol stearate (PGS), the relevant hydrolysis products and structural analogues.
PGMS and PGS are both UVCB substances, formed by esterification of propane-1,2-diol and stearic acid (and to a lesser extent palmitic acid) but PGS has a higher diester content and lower monoester content than PGMS. The UVCB substance belongs to the group of PGS, which are commonly used in cosmetics and as food ingredients (CIR 1983 and CIR 2015).
In order to assess the skin sensitisation potential of PGMS, the toxicity of PGS in general is therefore considered. Based on the data on PGS, the close similarity between PGS and PGMS and the identical QSAR predictions for the skin irritation potential of PGS and PGMS it can by weight of evidence be concluded that the data is considered acceptable for the present substance.
In general, data from the following expert assessments evaluating PGS are used in a weight of evidence approach:
CIR (1983). Final report on the safety assessment of propylene glycol stearate and propylene glycol stearate self-emulsifying. J Am Coll Toxicol 2(5), 101-124.
CIR (2015). Safety Assessment of Propylene Glycol Esters as Used in Cosmetics. Final amended report December8-9, 2014. 23 pp.
CIR (2019). Safety Assessment of Fatty Acids & Fatty Acid Salts as Used in Cosmetics. Tentative Report for Public Comment. January 4, 2019
EFSA (2018). 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
Guillot JP, Gonnet JF, Clément C, Faccini JM (1983). Comparative study of methods chosen by the Association Française de Normalisation (AFNOR) for evaluating sensitizing potential in the albino guinea-pig. Fd. Chem. Toxic. 21, 795-805
Basketter DA, Gerberick GF, Kimber I (1998). Strategies for identifying false positive responses in predictive skin sensitization tests. Food and Chemical Toxicology, 36, 327-333 - 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.
Stearic acid, monoester with propane-1,2-diol (PGMS) is an UVCB substance, formed by esterification of propane-1,2-diol and stearic acid (and to a lesser extent palmitic acid). The UVCB substance belongs to the group of propylene glycol stearate (PGS), which are commonly used in cosmetics and as food ingredients.
In order to assess the skin sensitisation potential, the toxicity of PGS in general is therefore considered. PGS is very comparable to PGMS as the substances are formed by esterification of propane-1,2-diol and stearic acid (and to a lesser extent palmitic acid) although PGS has a higher diester content and lower monoester content than PGMS. As expert-reviewed information/reports on in vivo metabolism and toxicity are available, read-across to data on PGS is considered acceptable for the present substance. - Type of study:
- other: weight of evidence analysis based on expert evaluated data on hydrolysis products and structural analogues using in vivo/in vitro data
- Remarks on result:
- other: Based on the studies available for propylene glycol stearate, the relevant hydrolysis products and the components of the UVCB substance, it is concluded that the test substance is not a skin sensitiser.
- Remarks on result:
- other: Based on the studies available for propylene glycol stearate, the relevant hydrolysis products and the components of the UVCB substance, it is concluded that the test substance is not a skin sensitiser.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No relevant testing data for stearic acid, monoester with propane-1,2-diol (PGMS) regarding skin sensitisation is available and also, no conclusive data is available for propylene glycol stearate (PGS) which is widely used in cosmetics (PGS has a higher fraction of diester compared to PGMS). A limited study in two guinea pigs using intracutan injections of 0.1% (PGS) did not result in sensitisation. Further, clinical testing of cosmetic formulations containing PGS in a concentration of 1.5-2.5% did not result in any cases of sensitisation among 4984 subjects suggesting a lack of skin sensitising properties. Danish QSAR database predictions of propylene glycol monostearate further indicate lack of a skin sensitising properties. Also, in relation to the primary starting materials and possible product of hydrolysis of PGMS, propane-1,2-diol and stearic acid, there is no concern for skin sensitising properties according to experimental animal data for propane-1,2-diol and according to QSAR predictions for stearic acid. So, overall, and by weight of evidence PGMS is concluded without potential for skin sensitisation. Thus, PGMS is not to be classified as a skin sensitiser according to the CLP-criteria (EC no 1272/2008).
- Executive summary:
No test data on stearic acid, monoester with propane-1,2-diol (PGMS) is available for skin sensitisation, but some data on propylene glycol stearate (PGS), that contains a higher fraction of diesters as PGMS is available from CIR safety assessments reports evaluating the use of PGS in cosmetics (CIR 1983 and CIR 2015). Furthermore, QSAR predictions are included in the overall weight of evidence assessment.
A limited study in two guinea pigs using intracutaneous injections of 0.1% (PGS) did not result in sensitisation. Further, clinical testing of cosmetic formulations containing PGS in a concentration of 1.5-2.5% did not result in any cases of sensitisation among 4984 subjects suggesting a lack of skin sensitising properties. Danish QSAR database predictions of propylene glycol monostearate further indicate lack of a skin sensitising properties. Also, in relation to the primary starting materials and possible product of hydrolysis of PGMS, propane-1,2-diol and stearic acid, there is no concern for skin sensitising properties according to experimental animal data for propane-1,2-diol and according to QSAR predictions for stearic acid.
So, overall, and by weight of evidence PGMS is concluded without potential for skin sensitisation. Thus, PGMS is not to be classified as a skin sensitiser according to the CLP-criteria (EC no 1272/2008).
Overall, the 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data on PGS, the close similarity between PGS and PGMS and the identical QSAR predictions for the skin sensitisation potential of PGS and PGMS, using an weight of evidence approach PGMS is concluded without potential for skin sensitisation. Thus, PGMS is not to be classified as a skin sensitiser according to the CLP-criteria (EC no 1272/2008).
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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