White petrolatum (Ph. Eur.) is virtually non‐sensitizing. Analysis of IVDK data on 80 000 patients tested between 1992 and 2004 and short discussion of identification and designation of allergens

Schnuch, Axel; Lessmann, Holger; Geier, Johannes; Uter, Wolfgang

doi:10.1111/j.0105-1873.2006.00854.x

Cited by 12 publications

(8 citation statements)

References 38 publications

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“…In humans, patch-test studies with medicinal white oils or waxes showed no skin sensitization (in almost 80 000 patients 18 ) or only mild erythema in sporadic cases even on damaged skin. 8,[18][19][20] These cases were never related to cosmetic allergy. White petrolatum and waxes are hence considered non-sensitizers and rarely allergen, the sensitizing components being probably PAH.…”

Section: Cutaneous Exposurementioning

confidence: 99%

“…In humans, patch‐test studies with medicinal white oils or waxes showed no skin sensitization (in almost 80 000 patients) or only mild erythema in sporadic cases even on damaged skin . These cases were never related to cosmetic allergy.…”

Section: Toxicity and Cutaneous Side‐effectsmentioning

confidence: 99%

“…White petrolatum and waxes are hence considered non-sensitizers and rarely allergen, the sensitizing components being probably PAH. 18,21 Other human studies pointed out that moisturizers containing 10% of mineral oil have a slight reducing effect on the minimal erythemal dose (MED) of skin for UVB irradiation (decreased by 5-16%), making the skin slightly more sensitive to UV, but this sensitivity effect to the sun was similar to that of seasonal changes (average MED increase of 14% between January and April). 22 Thus, according to current data in humans, there is no robust evidence on dermatotoxicity, detrimental sun sensitivity and toxicological effects of mineral oils via the cutaneous route.…”

Section: Cutaneous Exposurementioning

confidence: 99%

See 2 more Smart Citations

Mineral oils and waxes in cosmetics: an overview mainly based on the current European regulations and the safety profile of these compounds

Chuberre

Araviiskaia

Bieber

et al. 2019

Acad Dermatol Venereol

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Mineral oils and waxes are mixtures of predominantly saturated hydrocarbons consisting of straight‐chain, branched and ring structures with carbon chain lengths greater than C14. They have been used for many decades in skin and lip care cosmetic products due to their excellent skin tolerance as well as their high protecting and cleansing performance and broad viscosity options. In contrast to vegetable oils, mineral oils are non‐allergenic since they are highly stable and not susceptible to oxidation or rancidity. They have a long history of safe use which is confirmed by clinical and epidemiological data. In Europe, mineral oils are only permitted in cosmetics if compliant with purity specifications on polycyclic aromatic hydrocarbons and safety requirements laid down in the European pharmacopoeia and the EU cosmetics regulation EC/1223/2009. The high quality of these mineral oils is assured by robust quality assurance and a refining/purification process designed to exclude substances with carcinogenic potential and to minimize the presence of mineral oil aromatic hydrocarbons. Given their highly lipophilic properties, mineral oils do not penetrate human skin and, thus, are not systemically bioavailable in the body. Moreover, no significant changes in the skin and no effects on any internal organ system have been reported and attributed to the topical application of refined mineral oils. Regarding potential oral exposure from cosmetic lip care products, Cosmetics Europe, the European trade association for the cosmetics and personal care industry, has advised cosmetic manufacturers to only use mineral oil fractions for which recognized food acceptable daily intake (ADI) values apply. The estimated dose of mineral oils ingested via lip care products contributes to <10% of the ADI value and should therefore be considered of no toxicological concern.

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Section: Cutaneous Exposurementioning

confidence: 99%

Section: Toxicity and Cutaneous Side‐effectsmentioning

confidence: 99%

Section: Cutaneous Exposurementioning

confidence: 99%

See 1 more Smart Citation

Mineral oils and waxes in cosmetics: an overview mainly based on the current European regulations and the safety profile of these compounds

Chuberre

Araviiskaia

Bieber

et al. 2019

Acad Dermatol Venereol

View full text Add to dashboard Cite

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“…Paraffinöl in zahlreichen tierexperimentellen Untersuchungen als Vehikel, auch für intradermale Applikationen, verwendet wurde, ohne dabei zu einer Sensibilisierung zu führen, ist eine Sensibilisierung durch den Kontakt nicht zu erwarten. Die kontaktsensibilisierende Wirkung derartiger gereinigter Paraffinöle ist genauso zu bewerten wie die der ebenfalls nicht sensibilisierenden und daher auch im Epikutantest beim Menschen als Vehikel eingesetzten (weißen) Vaseline (Schnuch et al 2006). …”

Section: Hautsensibilisierende Wirkungunclassified

Mineralöle (Erdöl), stark raffiniert [MAK Value Documentation in German language, 2018]

Hartwig

Arand²

2018

The MAK‐Collection for Occupational Health and Safety

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The German Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area has evaluated 4 severely refined mineral oils [ 92062‐35‐6 , 72623‐83‐7 , 92045‐45‐9 , 92045‐44‐8 ] considering all toxicological endpoints. These mineral oils are severely refined to eliminate olefins and carcinogenic polycyclic aromatic hydrocarbons. The critical effect is lung toxicity which is observed as microgranulomas in two long‐term studies with rats and dogs at a respirable aerosol concentration of 100 mg/m 3 with a NOAEC of 5 mg/m 3 . A MAK value of 5 mg/m 3 has been set as the respirable fraction (R). Severely refined mineral oils have been assigned to Peak Limitation Category II, because the lung effects are due to a cumulative overload and an excursion factor of 4 has been set. Severely refined mineral oils are not genotoxic and not carcinogenic after oral, dermal or subcutaneous application to rats and mice. Developmental toxicity studies with a white mineral oil show a NOAEC of 1000 mg/m 3 and a NOAEL of 5000 mg/kg body weight in rats. After toxicokinetic scaling, the differences of the resulting respective concentrations at the workplace to the MAK value are sufficient. Therefore, damage to the embryo or foetus is unlikely when the MAK value is observed and severely refined mineral oils are assigned to Pregnancy Risk Group C. Skin absorption is very limited and does not contribute to systemic toxicity. Severely refined mineral oils are not regarded as skin or respiratory sensitizers.

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“…Petrolatum rarely causes hypersensitivity reactions, although a few sporadic cases of contact allergy to petrolatum, which is used as a vehicle in patch test preparations, have been reported in humans (Dooms-Goossens and Degreef, 1980;Kang et al, 2004;Kundu et al, 2004;Tam and Elston, 2006). A large retrospective analysis of patch test data in humans indicating true allergic patch test reactions to white petrolatum are extremely rare and probably as a result of an individually increased susceptibility to allergens and/or irritants (Schnuch et al, 2006).…”

Section: Introductionmentioning

confidence: 99%

Dermal irritation of petrolatum in rabbits but not in mice, rats or minipigs

Chandra

Peterson

Melich

et al. 2013

J of Applied Toxicology

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Petrolatum is widely used in cosmetics, topical pharmaceuticals and also as a vehicle in dermal toxicity studies. New Zealand white rabbits treated with white petrolatum (vehicle control) in a 2-week dermal irritation study exhibited moderate to severe erythema starting on Day 7 that subsided towards the end of the study. Histological examination of abraded and non-abraded petrolatum-treated skin obtained at termination (Day 15) revealed mild acanthosis, hyperkeratosis, dermal edema with mixed inflammatory cells in the dermis. Macroscopic and microscopic features noted in rabbits were consistent with dermal irritation to petrolatum. Wistar-Han rats, CD1 mice, C57/Bl/6J mice and Göttingen minipigs treated topically with white petrolatum did not exhibit clinical or histologic evidence of dermal irritation. Therapeutic agents developed for topical application are generally tested in rabbits during some point in development. Interpretation of skin irritation data from a single species can impact risk assessment for humans and on product labeling.

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White petrolatum (Ph. Eur.) is virtually non‐sensitizing. Analysis of IVDK data on 80 000 patients tested between 1992 and 2004 and short discussion of identification and designation of allergens

Abstract: True allergic patch test reactions to white petrolatum are extremely rare and probably due to an individually increased susceptibility to allergens and/or irritants. This is in agreement with considering petrolatum as a non-sensitizer.

Cited by 12 publications

References 38 publications

Mineral oils and waxes in cosmetics: an overview mainly based on the current European regulations and the safety profile of these compounds

Mineral oils and waxes in cosmetics: an overview mainly based on the current European regulations and the safety profile of these compounds

Mineralöle (Erdöl), stark raffiniert [MAK Value Documentation in German language, 2018]

Dermal irritation of petrolatum in rabbits but not in mice, rats or minipigs

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