Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: weight of evidence analysis based on data on hydrolysis products as well as 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 is not available for Polyglycerol-2-caprate. The possible acute toxicity by dermal route 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.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Principles of method if other than guideline:
The weight of evidence analysis is based on studies described in expert reports and QSAR predictions.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels
Key result
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the studies available in the present analysis it is concluded that the NOAEL for compound Polyglycerol-2-caprate in regards to dermal toxicity is expected to be > 2000 mg/kg day. Polyglycerol-2-caprate should not be classified for acute dermal toxicity.
Executive summary:

No data are available on Polyglycerol-2-caprate on acute toxicity by dermal exposure. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products as well as the components in the UVCB substance.

In the evaluation of polyglyceryls by CIR (2016), one study on acute toxicity by dermal route is reported. The study is performed on Wistar rats and 5 g/kg (5.2 mL/kg bw) was applied with a semi-occlusive patch for 24 h. An LD50of >5000 mg/kg was found and no local effects were observed (CIR 2016).

QSAR estimations support the low dermal toxicity with LD50 values in the range of 2200-2500 mg/kg/d for subcutaneous administration of the decanoic monoester of glyceryl and the dilaurate ester with diglyceryl.

As the Polyglycerol-2-caprate is expected to hydrolyse upon skin penetration, it is also relevant to consider decanoic acid being administrated by the subcutaneous exposure route. The LD50 is estimated to be 3500 mg/kg/d.

The dermal toxicity of the other constituents in the UVCB substance, diglycerol and triglycerol, is estimated with LD50 values of 5500 mg/kg/d and above.

Based on the studies available in the present analysis it is concluded that the NOAEL for compoundPolyglycerol-2-capratein regards to dermal toxicity is expected to be > 2200 mg/kg day. Polyglycerol-2-caprate should not be classified for acute dermal toxicity.