Chemical Substance - Mineral oil

NHPID name:
Mineral oil

Reference:
USPD

Proper name(s):
Mineral oil

Common name(s):

Category:
Approved Chemical Name
Monograph(s):
Diaper rash treatment monograph , Medicated Skin Care Products Monograph

CAS registry number:
8012-95-1

Other registry numbers:
102819-98-7 , 106803-31-0 , 115251-26-8 , 116357-36-9 , 122176-99-2 , 146908-77-2 , 172307-10-7 , 187112-19-2 , 188832-17-9 , 219686-29-0 , 261380-10-3 , 331464-54-1 , 37231-69-9 , 37232-05-6 , 37232-06-7 , 37232-07-8 , 39290-23-8 , 39296-25-8 , 39355-08-3 , 39355-09-4 , 39355-35-6 , 39464-77-2 , 39464-78-3 , 50935-85-8 , 50935-95-0 , 51004-58-1 , 51109-96-7 , 52012-27-8 , 52012-28-9 , 53028-74-3 , 58391-38-1 , 58615-80-8 , 60327-80-2 , 74870-90-9 , 79956-36-8 , 8015-59-6 , 8033-89-4 , 8038-04-8 , 8039-14-3 , 8039-75-6 , 8042-47-5 , 8043-78-5 , 83046-05-3 , 97048-20-9 , 99551-14-1




Toxicity restriction:

Detail:
Acceptable daily intake: MINERAL OIL (HIGH-VISCOSITY): 0-20 mg/kg bw; MINERAL OIL (MEDIUM- AND LOW-VISCOSITY): CLASS I, 0-1 mg/kg bw (temporary); CLASS II and CLASS III, 0-0.01 mg/kg bw (temporary group ADI)

Related links:

Reference:
JECFA


Roles

Non-medicinal

Purposes:
Fragrance Ingredient , Lubricant , Oleaginous Vehicle , Skin-Conditioning Agent - Emollient , Skin-Conditioning Agent - Occlusive , Solvent
Restrictions:

General:

Reference:
UNAVA

Non-NHP

Rationale:

Mineral oil is a non-NHP because it is not falling under Schedule 1 to the NHP Regulations. If Mineral oil is declared as a medicinal ingredient in a product, the product is a drug, not an NHP. A Drug Identification Number Application should be submitted to Health Canada for this product.If mineral oil is 1) declared as a non-medicinal ingredient and 2) is present at a concentration that is less than 50% (or less than 30% when in combination with colloidal oatmeal), the product is an NHP. A Natural Health Product Licence Application should be submitted to Health Canada for this product.If mineral oil is 1) declared as a non-medicinal ingredient and 2) is present at a concentration that is greater than or equal to 50% (or greater than or equal to 30% when in combination with colloidal oatmeal) and 3) it contributes to the claim (e.g. the Recommended Use or Purpose on the product is a statement to the effect of those permitted for mineral oil on the Diaper Rash Products or Medicated Skin Care Products monographs), then the product is considered a drug. A Drug Identification Number Application should be submitted to Health Canada for this product.If mineral oil is 1) declared as a non-medicinal ingredient and 2) is present at a concentration that is greater than or equal to 50% (or greater than or equal to 30% when in combination with colloidal oatmeal) and 3) does not contribute to the claim (as defined above), the product is an NHP. A Natural Health Product Licence Application should be submitted to Health Canada for this product.

Reference:  NNHPD
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