Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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:
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 dermal 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 dermal 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 polyglyceryl esters, the relevant hydrolysis products and the components of the UVCB substance it can with a high degree of confidence be concluded that the LD50-value of the test substance ‘Reaction product of saturated palm kernel fatty acids and oxybispropanediol’ is above 5000 mg/kg bw, the highest relevant dose level when testing for acute toxicity. Thus, the reaction product of saturated palm kernel fatty acids and oxybispropanediol is not to be classified for acute dermal toxicity.
Executive summary:

No studies for acute dermal toxicity 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.

Based on the only acute dermal toxicity study available for polyglyceryl esters, the relevant hydrolysis products and the components of the UVCB substance, a LD50>5000 mg/kg bw was found in rats. Hence it can with a high degree of confidence also be concluded that the LD50-value of the test substance ‘Reaction product of saturated palm kernel fatty acids and oxybispropanediol’ is above 5000mg/kg bw the highest relevant dose level when testing for acute toxicity. Thus, the reaction product of saturated palm kernel fatty acids and oxybispropanediol is not to be classified for acute dermal toxicity.