Final Report on the Safety Assessment of Propylene Glycol (PG) Dicaprylate, PG Dicaprylate/Dicaprate, PG Dicocoate, PG Dipelargonate, PG Isostearate, PG Laurate, PG Myristate, PG Oleate, PG Oleate SE, PG Dioleate, PG Dicaprate, PG Diisostearate, and PG Dilaurate

Johnson, Wilbur

doi:10.1177/109158189901800207

Cited by 19 publications

(2 citation statements)

References 11 publications

(10 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Acute oral toxicity of propane‐1,2‐diol ester of lauric acid (no further details) were studied in rats (no further details available) (Stepan Company, , as referred to by Johnson, ). The LD 50 was greater than 34,600 mg/kg bw and the test substance was classified as practically nontoxic.…”

Section: Assessmentmentioning

confidence: 99%

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Flavourings¹,

Younes²,

Aquilina³

et al. 2018

EFS2

View full text Add to dashboard Cite

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of propane-1,2-diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane-1,2-diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short-term studies in rats and dogs at the highest doses tested. The Panel considered that E 477 did not raise a concern for genotoxicity. No chronic toxicity, carcinogenicity, reproductive and developmental toxicity studies with propane-1,2-diol esters of fatty acids were available to the Panel. The Panel considered that any potential adverse effect of propane-1,2-diol ester of fatty acids would be due to propane-1,2-diol, previously re-evaluated as a food additive and for which an ADI of 25 mg/kg bw per day was established. Considering the overall metabolic and toxicity database, the Panel confirmed the previously established ADI for propane-1,2-diol esters of fatty acids (E 477) of 25 mg/kg bw per day expressed as propane 1,2 diol. This corresponds to an ADI for E 477 of 80 mg/kg bw per day, based on the concentration of free and bound propane-1,2-diol amounting to a maximum of 31% as laid down in the EU specification. The Panel concluded that there would not be a safety concern at the reported use levels for E 477 because exposure estimates from the refined non-brand loyal scenario did not exceed the ADI for E 477 in any of the population groups. However, the Panel aims to explore the feasibility of establishing a group ADI for those food additives that result in an exposure to propane-1,2-diol, such as E 477, E 1520 and E 405. Additionally, the Panel will also consider performing a combined exposure assessment to propane-1,2-diol resulting from the use of these food additives. The Panel also recommended some modifications of the EU specifications for E 477.This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.Re-evaluation of propane-1,2-diol esters of fatty acids (E 477) as a food additive www.efsa.europa.eu/efsajournal 2 EFSA Journal 2018;16(12):5497 SummaryThe Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated propane-1,2-diol esters of fatty acids in 1974 and stated that there is evidence for hydrolysis of propane-1,2-diol esters of fatty acids resulting in the products propane-1,2-diol, for which an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day has previously established, and fatty acids. JECFA established an ADI of 25 mg/kg bw per day for propane-1,2-diol esters of fatty acids, this ADI was expressed as propane-1,2-dio...

show abstract

Section: Assessmentmentioning

confidence: 99%

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Flavourings¹,

Younes²,

Aquilina³

et al. 2018

EFS2

View full text Add to dashboard Cite

show abstract

“…The formulation examined consisted of propylene glycol (PG), propylene glycol monolaurate (PGML) and isopropyl myristate (IPM). These substances are commonly used in cosmetic formulations as solvents and skin conditioning agents (31‐33), and they have been reported to act as penetration enhancers for several compounds (34,35). Recently, we investigated the skin delivery of EA from various binary and ternary solvent mixtures in vitro and a PG:PGML:IPM vehicle was the most effective in promoting skin permeation of the active (36).…”

Section: Introductionmentioning

confidence: 99%

A comparison of the in vitro permeation of 3‐O‐ethyl‐l‐ascorbic acid in human skin and in a living skin equivalent (LabSkin™)

Iliopoulos¹,

Chapman²,

Lane³

2020

Intern J of Cosmetic Sci

View full text Add to dashboard Cite

OBJECTIVESThe safety assessment of personal care products often entails determining dermal absorption of their ingredients. Such experiments are typically performed in human or animal skin in vitro; however, ethical and safety considerations are associated with obtaining these tissues. Several human skin equivalent models (HSEs) have been developed as alternatives to human tissue. The barrier function of such models however, is normally less developed than human skin. Here, we examine the permeability of the HSE LabSkinTM to a model compound, 3‐O‐ethyl‐l‐ascorbic acid (EA) compared with human skin.METHODSSkin uptake and permeation of EA was investigated in vitro using heat‐separated human epidermis and LabSkinTM. Finite dose (5 μL cm‐2) Franz‐diffusion studies were conducted using 2 % (w/w) EA in a ternary solvent mixture comprising propylene glycol (PG), propylene glycol monolaurate (PGML), and isopropyl myristate (IPM). These excipients are commonly used in cosmetic products and they have been reported to promote permeation of EA in a different model, namely porcine skin.RESULTSPermeation of EA through LabSkinTM was evident from 2 h; however, EA permeation in human skin was not detected until 5 h. Similar amounts of EA permeated through the two membranes at time points 8, 10, 12 and 24 h (p > 0.05). The cumulative amounts of EA delivered through LabSkinTM at 24 h were 41.3 ± 2.0 µg cm−2, corresponding to 55.1 ± 1.8 % of the applied dose. Similar amounts permeated across human skin, 49.4 ± 4.1 µg cm−2, accounting for 58.0 ± 4.2 % of the dose applied (p > 0.05).CONCLUSIONThe permeation of EA in LabSkinTM compared well with results for human epidermis in terms of the permeation profiles and the cumulative amounts of EA that permeated. The data suggest that the skin barrier of the two models was similar with regard to their overall permeability to the hydrophilic active EA. The findings are promising for the use of LabSkinTM as a surrogate for human skin in permeability testing. Future studies will focus on exploring the reproducibility and robustness of LabSkinTM for delivery of other actives that span a range of physicochemical properties.

show abstract

Appendix E: Common Vehicles for the Nonclinical Evaluation of Therapeutic Agents

2016

Drug Safety Evaluation

View full text Add to dashboard Cite

Final Report on the Safety Assessment of Propylene Glycol (PG) Dicaprylate, PG Dicaprylate/Dicaprate, PG Dicocoate, PG Dipelargonate, PG Isostearate, PG Laurate, PG Myristate, PG Oleate, PG Oleate SE, PG Dioleate, PG Dicaprate, PG Diisostearate, and PG Dilaurate

Cited by 19 publications

References 11 publications

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

A comparison of the in vitro permeation of 3‐O‐ethyl‐l‐ascorbic acid in human skin and in a living skin equivalent (LabSkin™)

Appendix E: Common Vehicles for the Nonclinical Evaluation of Therapeutic Agents

Contact Info

Product

Resources

About