Mineral Oil in Skin Care: Safety Profile


Species

No of animals

Duration

Material

Dose mg/kg/day

Results

C3H/HeJ mice

50

3 × per week over lifetime

White oil

296

No histopathological changes, no tumors

C3H/HeJ mice

50

3 × per week over lifetime

White oil

296

No abnormalities in visceral organs

C3H/HeJ mice

140

3 × per week over lifetime

White oil

296

No abnormalities in visceral organs

C3H/HeJ mice

40

2 × per week over 24 months

White oil

296

No abnormalities in visceral organs

C3H/HeJ mice

30

3 × per week over lifetime

White oil

238

No abnormalities in visceral organs

50

296

F344 rats

10

2 × per week over 91 days

Mineral oil

41

Increase in liver weight

C3H mice

10

Mineral oil

143

No abnormalities in visceral organs, minor dermal irritation

New Zealand white rabbits

4

20 days followed by 14 days no treatment

99 % mineral oil

2000

No dermal, hematological or histopathological changes in all groups

16 % mineral oil

2000





Human Studies


A series of human studies have been conducted by Johnson & Johnson Consumer Companies, Inc. to test the allergic potential of skin care products with high content of pharmaceutical grade mineral oil (> 90 %; Johnson & Johnson Consumer Companies Inc). The tests included human repeated insult patch test (HRIPT) on a total of 1035 subjects, cumulative irritation test on 137 subjects, phototoxicity on 60 subjects, and photoallergy tests on 171 subjects. The results of these studies are summarized in Table 19.2. In all the tests there was no allergic, phototoxic, and photoallergic responses and in the case of the cumulative irritation tests the finding was negligible irritation potential.




Table 19.2
Safety data of skin care products with high content (> 90 %) of pharmaceutical grade mineral oil. (Johnson & Johnson Consumer Companies Inc)
































































Mineral oil content (%)

HRIPT

Cumulative irritation

Phototoxicity

Photoallergy

90.58

No induced allergic responses (0/216)a

Not conducted

No phototoxic responses (0/10)

No photoallergic or induced allergic responses (0/29)

91.35

Not conducted

Not conducted

No phototoxic responses (0/10)

No photoallergic or induced allergic responses (0/30)

93.08

No induced allergic responses (0/198)

Negligible irritation potential (0/672)

No phototoxic responses (0/10)

No photoallergic or induced allergic responses (0/30)

98.00

No induced allergic responses (0/220)

Negligible irritation potential (0/648)

No phototoxic responses (0/10)

No photoallergic or induced allergic responses (0/24)

98.75

Not conducted

Negligible irritation potential (0.5/744)

Not conducted

Not conducted

99.65

Not conducted

Negligible irritation potential (4/528)

Not conducted

Not conducted

99.85

No induced allergic responses (0/208)

Negligible irritation potential (0.5/696)

No phototoxic responses (0/10)

No photoallergic or induced allergic responses (0/30)

99.98

No induced allergic responses (0/193)

Not conducted

No phototoxic responses (0/10)

No photoallergic or induced allergic responses (0/28)


HRIPT human repeated insult patch test

aNumbers in parentheses show positive responses per number of subjects, except in the cumulative irritation test where the numbers show cumulative irritation score per maximum possible irritation score



Is Mineral Oil Comedogenic?


Mineral oil has been suspected in popular press to cause blocking of skin pores, leading to acne and preventing toxins from escaping the body through the skin. However, recent studies using advanced measuring methods clearly demonstrated that the tested oils do not clog skin pores (Patzelt et al. 2012; Stamatas et al. 2008; DiNardo 2005). These studies concluded that mineral oil and vegetable oils used in skin care products form a protective layer on the skin, enhancing moisture retention, while allowing the skin to breathe without obstructing the pores. Wiechers et al. evaluated the effect of individual, blended, and formulated emollients on the mechanical properties of skin resulting in a defined tactile sensory perception (Wiechers 2008). The study recognized the existence of occlusion as a safe moisture-control mechanism, which depends principally on the choice of the emollients and by choosing the right emulsifier (Wiechers 2008; Caussin et al. 2007; Strübmann et al. 1993).

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Oct 15, 2016 | Posted by in Dermatology | Comments Off on Mineral Oil in Skin Care: Safety Profile

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