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) |
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).