Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Type of information:
other: weight of evidence assessment based 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 data is available for Reaction product of saturated palm kernel fatty acids and oxybispropanediol . The toxicokinetics of this substance is therefore assessed in a weight of evidence analysis based on existing data on polyglycerol fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance.

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

The following type of substances were included in the assessments: other glycerol esters (both data and QSAR), glycerols, fatty acids and alcohol ethoxylates. The main data sources were: NICNAS, Danish EPA QSAR, the HERA reports for alcohol ethoxylates and fatty acids.

Data source

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

Materials and methods

Test material

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

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Reaction product of saturated palm kernel fatty acids and oxybispropanediol is hydrolysed in the stomach and in the intestine and is readily absorbed.
Details on distribution in tissues:
The majority of Reaction product of saturated palm kernel fatty acids and oxybispropanediol is distributed to the liver where it is further utilized.
Details on excretion:
Reaction product of saturated palm kernel fatty acids and oxybispropanediol is excreted in the urine and feces, however, a large proportion is utilized and excreted as CO2

Metabolite characterisation studies

Details on metabolites:
No data exist on the toxicokinetics of Reaction product of saturated palm kernel fatty acids and oxybispropanediol, however, several data exist on the toxicokinetics of the polyglyceryl fatty acid ester and hydrolysis products. Documentation that polyglycerol fatty acid esters are hydrolysed and absorbed efficiently in the stomach and in the intestines, exists and data show that fatty acids, glycerol and glycerides of fatty acids are readily absorbed and metabolised in the liver.

Applicant's summary and conclusion

Conclusions:
Based on the studies available for the group of polyglycerol fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, it is concluded that the compound Reaction product of saturated palm kernel fatty acids and oxybispropanediol is hydrolysed and absorbed efficiently in the stomach and in the intestines and metabolised primarily in the liver.
Executive summary:

No data exist on the toxicokinetics of “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”, however, several data exist on the toxicokinetics of the polyglyceryl fatty acid ester and hydrolysis products. Documentation that polyglycerol fatty acid esters are hydrolysed and absorbed efficiently in the stomach and in the intestines, exists and data show that fatty acids, glycerol and glycerides of fatty acids are readily absorbed and metabolised in the liver. Thus, it is concluded that the compound Reaction product of saturated palm kernel fatty acids and oxybispropanediol is hydrolysed and absorbed efficiently in the stomach and in the intestines and metabolised primarily in the liver.