PEG400 is a strongly hydrophilic polyethylene glycol used as an excellent solvent for a large number of substances. PEG400 is widely used in a variety of pharmaceutical formulations.

Treatment of Fischer 344 rats with PEG400 at a constant volume of 1.0, 2.5 or 5.0 mL/kg body weight/day 5 days/wk for 13 week does not result in any mortality attributed to chemical toxicity or changes in haematology or clinical chemistry findings^[1].
Guidelines (Following is our recommended protocol. This protocol only provides a guideline, and should be modified according to your specific needs).
The final concentration of PEG300 can go up to 50% in the formulations for intravenous and intramuscular injection without any toxic effects. In PEG400 based solubility-enabling formulations in oral delivery of lipophilic drugs, both the 60% and the 100% PEG-400 formulations allowed full solubilization of the dose throughout the entire gastrointestinal tract-like journey^[2][3].

MCE has not independently confirmed the accuracy of these methods. They are for reference only.

Room temperature in continental US; may vary elsewhere.

• [1]. Hermansky SJ, et al. Effects of polyethylene glycol 400 (PEG 400) following 13 weeks of gavage treatment in Fischer-344 rats. Food Chem Toxicol. 1995 Feb;33(2):139-49.

  [2]. Xiaoqin Wang, et al. Injectable silk-polyethylene glycol hydrogels. Acta Biomater. 2015 Jan;12:51-61.

  [3]. Avital Beig, et al. Striking the Optimal Solubility-Permeability Balance in Oral Formulation Development for Lipophilic Drugs: Maximizing Carbamazepine Blood Levels. Mol Pharm. 2017 Jan 3;14(1):319-327.

Rats^[1]

Fischer-344 rats (10/group/sex) are administered polyethylene glycol 400 (PEG400) by gavage at 1.0, 2.5 or 5.0 mL/kg (1. l, 2.8 and 5.6 g/kg, respectively) body weight/day 5 days/wk for 13 wk. Animals in the control group receive water by gavage (5.0 mL/kg body weight/treatment day). An additional 10 rats/sex/group are assigned to the control and high-dose groups for a 6-wk recovery period. Evaluation of potential renal toxicity is identified as a primary objective^[1].

MCE has not independently confirmed the accuracy of these methods. They are for reference only.

• [1]. Hermansky SJ, et al. Effects of polyethylene glycol 400 (PEG 400) following 13 weeks of gavage treatment in Fischer-344 rats. Food Chem Toxicol. 1995 Feb;33(2):139-49.

  [2]. Xiaoqin Wang, et al. Injectable silk-polyethylene glycol hydrogels. Acta Biomater. 2015 Jan;12:51-61.

  [3]. Avital Beig, et al. Striking the Optimal Solubility-Permeability Balance in Oral Formulation Development for Lipophilic Drugs: Maximizing Carbamazepine Blood Levels. Mol Pharm. 2017 Jan 3;14(1):319-327.