Reaction product of the esterification of diglycerol with decanoic acid (Old name: 1,2,3-Propanetriol, homopolymer, decanoate)

Acute Toxicity: oral

Administrative data

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.

Data source

Reference

Reference Type:

other: weight of evidence document

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Principles of method if other than guideline:

Weight of evidence analysis based on studies according to OECD guideline 401 and EPA OPPTS 870.1100

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3-Propanetriol, homoplymer, decanoate

EC Number:

616-105-5

Cas Number:

74504-65-7

Molecular formula:

Main component: C16H32O6

IUPAC Name:

1,2,3-Propanetriol, homoplymer, decanoate

Test material form:

liquid

Details on test material:

Reaction mass of 3-(2,3-dihydroxypropoxy)-2-hydroxypropyl decanoate and 1-(2,3-dihydroxypropoxy)-3-hydroxypropan-2-yl decanoate

Results and discussion

Effect levels

Key result

Dose descriptor:

LD50

Remarks:

rats

Effect level:

> 2 000 mg/kg bw

Applicant's summary and conclusion

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.