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EC number: 947-750-3 | CAS number: -
- 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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No studies on genotoxicity are available for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components in the UVCB substance.
Glycerol, fatty acids, di- and tri-glycerols as well as polyglycerols of fatty acid ester were evaluated as a food additive by EFSA in 2017 (EFSA 2017 a, b, c, d). Data on the genotoxicity is presented as part of the evaluation.
Regarding gene mutation in bacteria, studies with bacterial reverse mutation assay (Ames) is described in Salmonella Typhimurium strains TA100, TA1535, TA1537, TA98, TA1538 and Escherichia coli WP2uvrA with data comparable to current standards (OECD Guideline 471). Negative results were obtained in all studies with and without addition of S9 mix (EFSA 2017a, b, c).
Studies on genotoxicity in mammalian cells was evaluated in chromosome aberration test in Chinese hamster lung fibroblast cells and in a HGPRT gene mutation assay CHO cells were performed, both with negative results. Also, a study on sister chromatid exchange and unscheduled DNA synthesis was described. No cytotoxic effects, nor clastogenic activity, was reported in the studies, where the highest concentration used was 92 mg/ml, a dose level 18 times greater than the maximum dose level recommended in vitro by OECD Guideline no. 473. EFSA concluded that the available studies were sufficient for evaluation of this endpoint and indicating no clastogenic activity of glycerol in in vitro studies (EFSA 2017a, c).
EFSA (2017d) found no structural alerts for genotoxicity of polyglycerol esters of fatty acids based on their own QSAR analysis for this end-point and present predictions of mutagenicity in silico for oxybispropanediol, capric, lauric, myristic, palmitic and stearic was also negative.
One study on a polyglycerol fatty acid ester was positive in in vitro chromosomal aberration study in Chinese hamster V79 cells, however, when retested in human peripheral blood lymphocytes, the results were negative both in the absence and presence of S9 metabolic activation. As all other studies are negative, and the positive result could not be repeated, it is evaluated that also polyglycerol fatty esters are not genotoxic (EFSA 2017d).
Based on the studies available for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, a lack of mutagenic/ genotoxic potential is concluded for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol".
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- 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:
- No studies are available for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and structural analogues.
Reaction product of saturated palm kernel fatty acids and oxybispropanediol is an UVCB substance, manufactured by a reaction between saturated palm kernel oil fatty acids with diglycerol. The UVCB substance belongs to the group of polyglyceryl fatty acid esters, which are commonly used in cosmetics and as food ingredients.
In general, data from the following expert assessments evaluating polyglyceryl fatty acids esters, glycerol, fatty acids and mono- and di-glycerides of fatty acids are used in a weight of evidence approach:
CIR. Safety Assessment of Polyglyceryl Fatty Acid Esters as Used in Cosmetics, Final report, November 14, 2016
EFSA (2017a). Re-evaluation of glycerol (E 422) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(3):4720.
EFSA (2017b). Re-evaluation of fatty acids (E 570) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(5):4785
EFSA (2017c). Re-evaluation of mono- and di-glycerides of fatty acids (E 471) as food additives. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(11):5045
EFSA (2017d). Re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(12):5089 - Principles of method if other than guideline:
- The conclusion is based on a collection of data performed equivalent or similar to relevant guidelines. Please refer to attached weight of evidence document.
- Type of assay:
- sister chromatid exchange assay in mammalian cells
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- hepatocytes: male rat
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Conclusions:
- Based on the studies available for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, a lack of mutagenic/ genotoxic potential is concluded for Reaction product of saturated palm kernel fatty acids and oxybispropanediol.
- Executive summary:
No studies are available for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components in the UVCB substance.
Glycerol, fatty acids, di- and tri-glycerols as well as polyglycerols of fatty acid ester were evaluated as a food additive by EFSA in 2017. Data on the genotoxicity is presented as part of the evaluation.
Studies on gene mutation in mammalian cells was investigated in a HGPRT gene mutation assay, sister chromatid exchange study and unscheduled DNA synthesis, all with negative results. No cytotoxic effects was reported in the studies.
EFSA (2017d) found no structural alerts for genotoxicity of polyglycerol esters of fatty acids based on their own QSAR analysis for this end-point and present predictions of mutagenicity in silico for oxybispropanediol, capric, lauric, myristic, palmitic and stearic was also negative.
Based on the studies available for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, a lack of mutagenic/ genotoxic potential is concluded for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol".
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- 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:
- No studies are available for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and structural analogues.
Reaction product of saturated palm kernel fatty acids and oxybispropanediol is an UVCB substance, manufactured by a reaction between saturated palm kernel oil fatty acids with diglycerol. The UVCB substance belongs to the group of polyglyceryl fatty acid esters, which are commonly used in cosmetics and as food ingredients.
In general, data from the following expert assessments evaluating polyglyceryl fatty acids esters, glycerol, fatty acids and mono- and di-glycerides of fatty acids are used in a weight of evidence approach:
CIR. Safety Assessment of Polyglyceryl Fatty Acid Esters as Used in Cosmetics, Final report, November 14, 2016
EFSA (2017a). Re-evaluation of glycerol (E 422) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(3):4720.
EFSA (2017b). Re-evaluation of fatty acids (E 570) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(5):4785
EFSA (2017c). Re-evaluation of mono- and di-glycerides of fatty acids (E 471) as food additives. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(11):5045
EFSA (2017d). Re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(12):5089 - Principles of method if other than guideline:
- The conclusion is based on a collection of data performed equivalent or similar to relevant guidelines. Please refer to attached weight of evidence document.
- Type of assay:
- in vitro mammalian chromosome aberration test
- Specific details on test material used for the study:
- The conclusion is based on a collection of data performed equivalent or similar to relevant guidelines. Please refer to attached weight of evidence document.
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Conclusions:
- Based on the studies available for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, a lack of mutagenic/ genotoxic potential is concluded for Reaction product of saturated palm kernel fatty acids and oxybispropanediol.
- Executive summary:
No studies are available for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components in the UVCB substance.
Glycerol, fatty acids, di- and tri-glycerols as well as polyglycerols of fatty acid ester were evaluated as a food additive by EFSA in 2017 (EFSA 2017 a,b,c,d). Data on the genotoxicity is presented as part of the evaluation.
Cytogenicity in mammalian cells was investigated in chromosome aberration test in Chinese hamster lung fibroblast cells with negative results where the highest concentration used was 92 mg/ml, a dose level 18 times greater than the maximum dose level recommended in vitro by OECD Guideline no. 473. EFSA concluded that the available studies were sufficient for evaluation of this endpoint and indicating no clastogenic activity of glycerol in in vitro studies (EFSA 2017a, c).
EFSA (2017d) found no structural alerts for genotoxicity of polyglycerol esters of fatty acids based on their own QSAR analysis for this end-point and present predictions of mutagenicity in silico for oxybispropanediol, capric, lauric, myristic, palmitic and stearic was alsonegative.
One study on a polyglycerol fatty acid ester was positive in vitro chromosomal aberration study in Chinese hamster V79 cells, however, when retested in human peripheral blood lymphocytes, the results were negative both in the absence and presence of S9 metabolic activation. As all other studies are negative, and the positive result could not be represented, it is evaluated that also polyglycerol fatty esters are not genotoxic (EFSA 2017d).
Based on the studies available for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, a lack of mutagenic/ genotoxic potential is concluded for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol".
- 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:
- No studies are available for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and structural analogues.
Reaction product of saturated palm kernel fatty acids and oxybispropanediol is an UVCB substance, manufactured by a reaction between saturated palm kernel oil fatty acids with diglycerol. The UVCB substance belongs to the group of polyglyceryl fatty acid esters, which are commonly used in cosmetics and as food ingredients.
In general, data from the following expert assessments evaluating polyglyceryl fatty acids esters, glycerol, fatty acids and mono- and di-glycerides of fatty acids are used in a weight of evidence approach:
CIR. Safety Assessment of Polyglyceryl Fatty Acid Esters as Used in Cosmetics, Final report, November 14, 2016
EFSA (2017a). Re-evaluation of glycerol (E 422) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(3):4720.
EFSA (2017b). Re-evaluation of fatty acids (E 570) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(5):4785
EFSA (2017c). Re-evaluation of mono- and di-glycerides of fatty acids (E 471) as food additives. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(11):5045
EFSA (2017d). Re-evaluation of polyglycerol esters of fatty acids (E 475) as a food additive. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(12):5089 - Principles of method if other than guideline:
- The conclusion is based on a collection of data performed equivalent or similar to relevant guidelines. Please refer to attached weight of evidence document.
- Type of assay:
- bacterial reverse mutation assay
- Key result
- Species / strain:
- S. typhimurium, other: TA100, TA1535, A1537, TA98, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Conclusions:
- Based on the studies available for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, a lack of mutagenic/ genotoxic potential is concluded for Reaction product of saturated palm kernel fatty acids and oxybispropanediol.
- Executive summary:
No studies are available for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components in the UVCB substance.
Glycerol, fatty acids, di- and tri-glycerols as well as polyglycerols of fatty acid ester were evaluated as a food additive by EFSA.
Regarding gene mutation in bacteria, studies with bacterial reverse mutation assay (Ames) is described in Salmonella Typhimurium strains TA100, TA1535, TA1537, TA98, TA1538 and Escherichia coli WP2uvrA with data comparable to current standards (OECD Guideline 471). Negative results were obtained in all studies with and without addition of S9 mix.
EFSA (2017d) found no structural alerts for genotoxicity of polyglycerol esters of fatty acids based on their own QSAR analysis for this end-point and present predictions of mutagenicity in silico for oxybispropanediol, capric, lauric, myristic, palmitic and stearic was also negative.
Based on the studies available for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, a lack of mutagenic/ genotoxic potential is concluded for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol".
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the studies available for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, a lack of mutagenic/ genotoxic potential is concluded for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Thus, "Reaction product of saturated palm kernel fatty acids and oxybispropanediol" should not be classified for mutagenicity.
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.