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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 and eye irritation 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.
Three experimental animal dermal irritation tests are available on propylene glycol stearate (PGS). This testing indicates no or very mild skin irritation potential of the substance. Further, a clinical evaluation with patch testing of 80 human subjects indicate lack of dermal irritation. PGS is very comparable to Stearic acid, monoester with propane-1,2-diol (PGMS) as the substances are 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. Based on the data on PGS, the close similarity between PGS and PGMS and further based on identical QSAR predictions for the skin irritation potential of the two substances, it can by weight of evidence be concluded that PGMS is not a skin irritant.
Three experimental animal eye irritation tests are available on propylene glycol stearate (PGS). This testing indicates no or very mild eye irritation potential of the substance. PGS is very comparable to Stearic acid, monoester with propane-1,2-diol (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. Based on the data on PGS, the close similarity between PGS and PGMS and further based on identical QSAR predictions for the eye irritation potential of the two substances, it can by weight of evidence be concluded that PGMS is not an eye irritant.
Overall, PGMS should not according to the CLP criteria, EC no 1272/2008 be classified with respect to skin and eye irritation.
Overall, the available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. Weight-of-evidence is justified based on common functional group and 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.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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 irritation 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. - 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 irritation 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 is available, read-across to data on PGS is considered acceptable for the present substance. - Remarks on result:
- other: Based on the data on PGS, the close similarity between PGS and PGMS and the identical QSAR predictions for skin and eye irritation potential of the two substances, it can by weight of evidence be concluded that PGMS is not a skin and eye irritant.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No studies are available for Stearic acid, monoester with propane-1,2-diol (PGMS). Data on skin irritation were therefore obtained for the group of propylene glycol stearate (PGS) in the UVCB substance (CIR 1983 and CIR 2015). Results from the human and animal studies on skin irritation of PGS were mostly negative results on skin irritation. Therefore, it is considered most likely that the same will apply for PGMS. Based on an overall weight of evidence from the available data it is concluded that PGMS is not to be classified for skin irritation, as the CLP criteria for classification, EC no 1272/2008 is not fulfilled.
- Executive summary:
No studies evaluating skin irritation are available for the UVCB substance stearic acid, monoester with propane-1,2-diol (PGMS) but data on propylene glycol stearate (PGS) is available from CIR safety assessments reports evaluating the use of PGS in cosmetics (CIR 1983 and CIR 2015).
Three experimental animal dermal irritation tests are available on PGS. This testing indicates no or very mild skin irritation potential of the substance. Further, a clinical evaluation with patch testing of 80 human subjects indicate lack of dermal irritation. 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) but PGS has a higher diester content and lower monoester content than PGMS. Based on the data on PGS, the close similarity between PGS and PGMS and further based on identical QSAR predictions for the skin irritation potential of the two substances, it can by weight of evidence be concluded that PGMS is not a skin irritant and is not to be classified for skin irritation, as the CLP criteria for classification, EC no 1272/2008 is not fulfilled.
Overall, the available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. Weight-of-evidence is justified based on common functional group and 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
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 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.
Three experimental animal dermal irritation tests are available on propylene glycol stearate (PGS). This testing indicates no or very mild skin irritation potential of the substance. Further, a clinical evaluation with patch testing of 80 human subjects indicates lack of dermal irritation. PGS is very comparable to Stearic acid, monoester with propane-1,2-diol (PGMS) as the substances are 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 a lower monoester content than PGMS. Based on the data on PGS, the close similarity between PGS and PGMS and further based on identical QSAR predictions for the skin irritation potential of the two substances, so it can by weight of evidence be concluded that PGMS is not a skin irritant.
Thus, according to the CLP criteria, EC no 1272/2008, PGMS should not be classified with respect to
skin irritation.
Overall, the available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. Weight-of-evidence is justified based on common functional group and 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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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 eye irritation 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 eye 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. - 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 eye irritation 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. - 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 an eye irritant
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No studies are available for Stearic acid, monoester with propane-1,2-diol (PGMS). Data on eye irritation were therefore obtained for the group of propylene glycol stearate (PGS) in the UVCB substance (CIR 1983 and CIR 2015). Results from the three animal studies on eye irritation of PGS were mostly negative results. Therefore, it was concluded that PGS is not an eye irritant. Based on an overall weight of evidence, PGMS should not according to the CLP criteria, EC no 1272/2008 be classified with respect to eye irritation.
- Executive summary:
No studies are available for Stearic acid, monoester with propane-1,2-diol (PGMS). Data on eye irritation were therefore obtained for the group of propylene glycol stearate (PGS) in the UVCB substance (CIR 1983 and CIR 2015).
Three experimental animal eye irritation tests are available on propylene glycol stearate (PGS). This testing indicates no or very mild eye irritation potential of the substance. PGS is very comparable to Stearic acid, monoester with propane-1,2-diol (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. Based on the data on PGS, the close similarity between PGS and PGMS and further based on identical QSAR predictions for the eye irritation potential of the two substances, it can by weight of evidence be concluded that PGMS is not an eye irritant.
Thus, PGMS should not according to the CLP criteria, EC no 1272/2008 be classified with respect to eye irritation.
Overall, the available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. Weight-of-evidence is justified based on common functional group and 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
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 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.
Three experimental animal eye irritation tests are available on propylene glycol stearate (PGS). This testing indicates no or very mild eye irritation potential of the substance. Based on the data on PGS, the close similarity between PGS and PGMS and further based on identical QSAR predictions for the eye irritation potential of the two substances, it can by weight of evidence be concluded that PGMS is not an
eye irritant.
Thus, according to the CLP criteria, EC no 1272/2008, PGMS should not be classified with respect to eye irritation.
Overall, the available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. Weight-of-evidence is justified based on common functional group and 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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on an overall weight of evidence from the available data on the group of propylene glycol stearate (PGS), it is concluded that Stearic acid, monoester with propane-1,2-diol (PGMS) is not to be classified for skin- and eye irritation, as the CLP criteria for classification is not fulfilled. In support, CIR (1983) and CIR (2015) concluded that propylene glycol stearate (PGS) is safe for use in cosmetics.
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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