Chemical Substance - Polysorbate 80

NHPID name:
Polysorbate 80

Reference:
CHEMID

Proper name(s):
Polysorbate 80

Common name(s):
Polysorbate 80

Category:
Approved Chemical Name



Toxicity restriction

Upper limit:
25.0

Units:
Milligrams/kilogram body weight/day

Detail:
Acceptable daily intake up to 25 mg/kg body weight daily as total for polyoxyethylene derivatives

Reference:
JECFA


Roles

Non-medicinal

Purposes:
Dispersing Agent , Emulsifying Agent , Plasticizer , Solubilizing Agent , Stabilizing Agent , Surfactant - Hydrotrope , Surfactant - Suspending Agent , Wetting Agent
Restrictions:

General

Detail:
Ophthalmic products with a concentration greater than or equal to 0.2% are considered a non-NHP.

Reference:
CFR_TITLE21_VOL5

Non-NHP

Rationale:

A non-NHP because not a naturally occurring substance included in Schedule 1 of the NHP Regulations.

Reference:  NNHPD