Polyoxyl 40 Hydrogenated Castor Oil

Category

Emulsifier; Solvent-enhancing; Base Agents; Dissolving aid; Dispersant; Coating Agents

UNII

7YC686GQ8F

Chemical Name

Polyethylene glycol (40) hydrogenated castor oil

CAS Number

61788-85-0

Synonyms

Polyoxyl (40) Hydrogenated Castor Oil; PEG(40) Hydrogenated Castor Oil; Polyoxyethylene Hydrogenated Castor Oil 40; EP(MACROGOLGLYCEROL HYDROOXYSTEARA TE); NF (Polyoxyl 40 Hydrogenated Castor Oil)

Administration route

Dentistry; Eyes; Oral; local

Dosage Form

Suspension, solution, capsule, cream, tablet, spray

Stability and Storage Conditions

Store closed in a cool, dry place. Avoid contact with acids, bases and oxidants.

Commonly used amount and the maximum amount

Maximum dosage of each administration route: oral: 160μg; General external preparation: 15mg/g; Dental external and oral medicine: 9mg/g; Rectum, duct and urethra 60.0mg/g.

Source and Preparation

This product is prepared by the reaction of 1mol hydrogenated castor oil with 40~45mol ethylene oxide. It mainly contains the trihydroxy-stearate ester of oxyethylene glycerol, a small amount of polyethylene trihydroxy-stearate ester and the corresponding free alcohol.

Safety

This product is non-toxic, safe, teratogenic, does not cause fetal poisoning, no irritation to the skin and mucosa, no signs of allergy. However, anaphylaxis has been reported during injection. Acute toxicity test LD50 > 16.0g/kg(rat, transoral), LD50 > 6.4g/kg(mouse, intraperitoneal), LD50 12.1g/kg(mouse, venous). Subacute toxicity test, pigs and dogs were taken orally for more than 4 weeks, when the feed contained 1%, 3%, 9%, no symptoms of injury were observed; The rats were taken orally for more than 4 weeks, the feed contained 3.2% and 6.4%, and no poisoning symptoms were found. In the chronic toxicity test, the rats and dogs were fed for 6 months with 5% and 10% feed. No toxic symptoms were found, and no abnormal changes were found in diet, body weight, blood image, urine and various animal organs. In inhalation toxicity test, some saturated air was released, and rats were inhaled for 8h, but no damage was observed. Aerosol does not cause irritation to human respiratory mucosa.

Incompatibilities

Compatible reactions occur with acids, bases and oxidants.