Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
other: Weight of evidence based on data on hydrolysis products
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
No data is available on polyglycerol-2-caprate. Data on the different constituents of the substance was used to obtain information on the acute toxicity by oral route. Because polyglycerol is a mixture consisting mainly of diglycerol, triglycerol and tetraglycerol and further information on metabolism in vivo and in vitro is available, this data is considered to be adequate for read-across. The weight of evidence document is attached below.
Principles of method if other than guideline:
Weight of evidence analysis based on studies according to OECD guideline 401 and EPA OPPTS 870.1100
Key result
Dose descriptor:
LD50
Remarks:
rats
Effect level:
> 2 000 mg/kg bw
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the weight of evidence assessment of the acute toxicity by oral route it is concluded that the reaction mass containing decanoic acid, 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl ester and decanoic acid, 1-(2,3-dihydroxypropoxy)-3-hydroxypropyl ester (Dermosoft DGMC) is of low acute oral toxicity and that no animal test is necessary. No impurities or by-products of high toxicity, its acute oral toxicity were identified in the Certificate of Analysis. Therefore, the acute oral toxicity in rats can be predicted by weight-of-evidence assessment to be higher than 2000 mg/kg body weight.
Executive summary:

No data was available on the acute toxicity by oral route for Dermosoft DGMC. Data on this endpount was therefore obtained for the main constituents in the substance as a weight of evidemce documentation of the toxicity. Thus, LD50(oral, rat) of 3320 mg/kg bw has been found for decanoic acid while a LD50(oral, rat) > 10g/kg bw was found of other polyglycerol esters of fatty acids. Based on this assessment it is concluded that the reaction mass containing decanoic acid, 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl ester and decanoic acid, 1-(2,3-dihydroxypropoxy)-3-hydroxypropyl ester (Dermosoft DGMC) is of low acute oral toxicity and that no animal test is necessary. No impurities or by-products of high toxicity, its acute oral toxicity were identified in the Certificate of Analysis. Therefore, the acute oral toxicity in rats can be predicted by weight-of-evidence assessment to be higher than 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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.
Principles of method if other than guideline:
The weight of evidence analysis is based on studies described in expert reports and QSAR predictions.
Key result
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification

No data were available on the acute toxicity for polyglycerol-2-caprate. Data on this endpoint was therefore obtained for the main constituents in the substance as a weight of evidence documentation of the toxicity.

Based on this assessment it is concluded that the polyglycerol-2-caprate is of low acute oral toxicity. No impurities or by-products of high toxicity, its acute oral toxicity were identified in the Certificate of Analysis. Therefore, the acute oral toxicity in rats can be predicted by weight-of-evidence assessment to be higher than 2000 mg/kg body weight.

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.

Polyglycerol-2 -caprate is based on an overall weight of evidence assessment not to be classified for acute toxicity.