Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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.