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Toxicological information

Genetic toxicity: in vitro

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Administrative data

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

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Paste
Details on test material:
Same ID as the registered substance

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Metabolic activation system:
S9

Results and discussion

Test resultsopen allclose all
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

Applicant's summary and conclusion

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".