Registration Dossier

Administrative data

Endpoint:
developmental toxicity
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:
Data on this endpoint are not available for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol". The possible reproductive/developmental toxicity of this substance is therefore assessed in the present weight of evidence analysis based on existing data on the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and the components in the UVCB substance. As the target substance and the source substances for the evaluation are UVCB-substances and as expert group assessments of the substances are considered the most valid data for the assessment, an overall weight of evidence approach is used for the assessment. For more details, please see attached weight of evidence document.

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.

Test material

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

Test animals

Species:
other: weight of evidence analysis based on expert evaluated data on hydrolysis products and structural analogues using data from different species.

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Remarks on result:
other: 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 an assumed NOAEL is far above 1000 mg/kg bw/day.

Results (fetuses)

Effect levels (fetuses)

Remarks on result:
other: 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 an assumed NOAEL is far above 1000 mg/kg bw/day.

Overall developmental toxicity

Key result
Developmental effects observed:
no
Lowest effective dose / conc.:
1 000 mg/kg bw/day (actual dose received)
Treatment related:
no

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 can with a high degree of confidence be concluded that an assumed NOAEL for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is far above 1000 mg/kg bw/day, which is normally considered as the highest relevant dose level when testing for reproduction and prenatal developmental toxicity. Thus, Reaction product of saturated palm kernel fatty acids and oxybispropanediol is not to be classified for reproductive or developmental toxicity.
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.

In a two-generation reproduction toxicity study and a prenatal developmental toxicity study in rats with diacylglycerol oil, rich in unsaturated fatty acids (>95%), showed no parental, reproductive and developmental effects up to the highest dose tested (4,630 mg diacylglycerol/kg bw per day). A NOAEL of 4630 mg diacylglycerol/kg bw per day for reproductive and developmental toxicity could be derived.

For glycerol (E 422), several prenatal developmental toxicity studies have been performed with mice, rats and rabbits (EFSA 2017a). NOAEL of 1280,1600 or 1180 mg glycerol/kg bw per day for mice, rats and rabbits, respectively, have been derived.

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 can with a high degree of confidence be concluded that an assumed NOAEL for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol" is far above 1000 mg/kg bw/day which is normally considered as the highest relevant dose level when testing for reproduction and prenatal developmental toxicity. Thus, "Reaction product of saturated palm kernel fatty acids and oxybispropanediol" is not to be classified for reproductive or developmental toxicity.