Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 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 order to assess the acute oral toxicity of the substance, the toxicity of polyglyceryl fatty acid esters in general is therefore considered. As polyglycerol contains of diglycerols together with triglycerols and tetraglycerols, and as information on metabolism in vivo and in vitro is available, read-across to data on these substances is considered acceptable for the present 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






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 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.

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 order to assess the acute oral toxicity, the toxicity of polyglyceryl fatty acid esters in general is therefore considered.

As polyglycerol contains of diglycerols together with triglycerols and tetraglycerols, and as information on metabolism in vivo and in vitro is available, read-across to data on these substances is considered acceptable for the present substance. In general, data on polyglycerol esters of fatty acids, mono- and diglycerides of fatty acids, glycerol/diglycerol and fatty acids will be used.

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

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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 lethal dose 50 (LD50) for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is above 10000 mg/kg, and well above 5000 mg/kg which is normally considered as the highest relevant dose level when testing acute toxicity. Thus, Reaction product of saturated palm kernel fatty acids and oxybispropanediol is not to be classified for acute oral 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.

Three studies are available on acute oral toxicity of glycerol, C12-C18 saturated fatty acids, and polyglycerol fatty acid esters in rats. For any of the three substances, which either is a part of the UVCB substance or a hydrolysis product the LD50 was above 10g /kg. The highest LD50-value (> 29g/kg) was found for poly glycerols of fatty acids, Glycerol had the second highest LD50 (12.6 -28.8g /kg), while the saturated fatty acids had the lowest LD50 value (>10g /kg). The overall conclusion is that all three substances have low acute oral toxicity with LD50-values well above the highest dose used for classification as acute toxicity (i.e. 2000- 5000 mg/kg).

Hence, low toxicity and no need for classification should be expected for Reaction product of saturated palm kernel fatty acids and oxybispropanediol as well.