Registration Dossier

Administrative data

Description of key information

No studies are available for Polyglycerol-2-caprate. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and structural analogues.

In the rat studies the animals were exposed to polyglycerol esters of fatty acids for 90 days and 22 weeks, respectively (EFSA, 2017b). No toxicity was seen in any of the studies.

In humans, 19-24 years of aged, exposed for 3 weeks to polyglycerol esters of fatty acids though the diet, no signs of toxicity were seen (EFSA, 2017b).

Three studies on mixtures of triglycerides were performed in rats. This was two 90-day studies and one 2 generation study. No adverse effects caused by decanoic acid and octanoic acid in form of medium-chain triglycerides was found. The NOAEL based on these studies was ≥ 7000 mg/kg bw/day (CLH report octanoic acid, 2012). For medium and long chain triglycerides, the NOAEL is reported to be ≥ 8000 mg/kg bw/day (Zhouet al., 2017).

For the fatty acids, a NOAEL for decanoic acid is reported to be > 1000 mg/kg bw/day (CAR Capric acid, 2013). One study was performed on tetra decanoic acid (Lauric acid) in rats reporting a NOEL of > 6000 mg/kg/day (Burdocket al., 2007).

Studies on repeated dose toxicity on synthetic and natural glycerine fed orally to rats is reported with a NOAEL of 10 000 mg/kg bw/d (ECHA, 2018) indicating that the glycerols are non-toxic.

Based on the available studies on the group of polyglyceryl fatty acid esters and the relevant hydrolysis products described above, it can based on an overall weight of evidence approach be concluded that the compound Polyglycerol-2-caprate is of very low concern for repeated dose toxicity. Thus, no STOT RE classification should apply for the substance.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
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:
Data on this endpoint are not available for Polyglycerol-2-caprate.
Metabolism studies of polyglycerol and polyglycerol esters in rats indicate that ester hydrolysis is taken place in the gastrointestinal tract when the substance is orally administrated. Studies also indicate that the polyglycerols are not metabolized in rats. The possible repeated dose 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 and the relevant hydrolysis products as well as data for glycerides containing medium chain fatty acids (8 to 10 carbon atoms).
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.
Principles of method if other than guideline:
The results are based on a weight of evidence analysis, based on a collection of studies performed similar to relevant guidelines and on QSAR evaluation. For more details please refer to the attached weight of evidence document.
Key result
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: Collection of relevant data. Please see attached document
Critical effects observed:
no
Conclusions:
Based on the available studies on the group of polyglyceryl fatty acid esters and the relevant hydrolysis products described above, it can based on an overall weight of evidence approach be concluded that the compound Polyglycerol-2-caprate is of very low concern for repeated dose toxicity. Thus, no STOT RE classification should apply for the substance.
Executive summary:

No studies are available forPolyglycerol-2-caprate. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and structural analogues.

In the rat studies the animals were exposed to polyclycerol esters of fatty acids for 90 days and 22 weeks, respectively (EFSA, 2017b). No toxicity was seen in any of the studies.

In humans, 19-24 years of aged, exposed for 3 weeks to polyglycerol esters of fatty acids though the diet, no signs of toxicity were seen (EFSA, 2017b).

Three studies on mixtures of triglycerides were performed in rats. This was two 90-day studies and one 2 generation study. No adverse effects caused by decanoic acid and octanoic acid in form of medium-chain triglycerides was found. The NOAEL based on these studies was ≥ 7000 mg/kg bw/day (CLH report octanoic acid, 2012). For medium and long chain triglycerides, the NOAEL is reported to be ≥ 8000 mg/kg bw/day (Zhouet al., 2017).

For the fatty acids, a NOAEL for decanoic acid is reported to be > 1000 mg/kg bw/day (CAR Capric acid, 2013). One study was performed on tetra decanoic acid (Lauric acid) in rats reporting a NOEL of > 6000 mg/kg/day (Burdocket al., 2007).

Studies on repeated dose toxicity on synthetic and natural glycerine fed orally to rats is reported with a NOAEL of 10 000 mg/kg bw/d (ECHA, 2018) indicating that the glycerols are non-toxic.

Based on the available studies on the group of polyglyceryl fatty acid esters and the relevant hydrolysis products described above, it can based on an overall weight of evidence approach be concluded that the compound Polyglycerol-2-caprate is of very low concern for repeated dose toxicity. Thus, no STOT RE classification should apply for the substance.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification