Risk assessment of topically applied products

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Standard

Risk assessment of topically applied products. / Søborg, Tue; Basse, Line Hollesen; Halling-Sørensen, Bent.

In: Toxicology, Vol. 236, No. 1-2, 2007, p. 140-148.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Søborg, T, Basse, LH & Halling-Sørensen, B 2007, 'Risk assessment of topically applied products', Toxicology, vol. 236, no. 1-2, pp. 140-148. https://doi.org/10.1016/j.tox.2007.04.011

APA

Søborg, T., Basse, L. H., & Halling-Sørensen, B. (2007). Risk assessment of topically applied products. Toxicology, 236(1-2), 140-148. https://doi.org/10.1016/j.tox.2007.04.011

Vancouver

Søborg T, Basse LH, Halling-Sørensen B. Risk assessment of topically applied products. Toxicology. 2007;236(1-2):140-148. https://doi.org/10.1016/j.tox.2007.04.011

Author

Søborg, Tue ; Basse, Line Hollesen ; Halling-Sørensen, Bent. / Risk assessment of topically applied products. In: Toxicology. 2007 ; Vol. 236, No. 1-2. pp. 140-148.

Bibtex

@article{842c1ff0c37011dcbee902004c4f4f50,
title = "Risk assessment of topically applied products",
abstract = "The human risk of harmful substances in semisolid topical dosage forms applied topically to normal skin and broken skin, respectively, was assessed. Bisphenol A diglycidyl ether (BADGE) and three derivatives of BADGE previously quantified in aqueous cream and the UV filters 3-BC and 4-MBC were used as model compounds. Tolerable daily intake (TDI) values have been established for BADGE and derivatives. Endocrine disruption was chosen as endpoint for 3-BC and 4-MBC. Skin permeation of the model compounds was investigated in vitro using pig skin membranes. Tape stripping was applied to simulate broken skin associated with various skin disorders. BADGE and derivatives had a tendency to permeate pig skin membranes in vitro with higher fluxes in the tape stripped membranes compared to the non-treated membranes. Data from the in vitro skin permeation study and from the literature were used as input parameters for estimating the risk. The immediate human risk of BADGE and derivatives in topical dosage forms was found to be low. However, local treatment of broken skin may lead to higher exposure of BADGE and derivatives compared to application to normal skin. 3-BC permeated skin at higher flux than 4-MBC. Both UV filters are endocrine disrupting compounds with 3-BC being the more potent. UV filters in sunscreen are often present in high concentrations, which potentially may lead to high systemic exposure dosages. Thus, the risk associated with use of 3-BC and 4-MBC containing sunscreen with regards to endocrine disrupting effects was found to be high and more data is urgently needed in order to fully assess the human risk of 3-BC and 4-MBC in commercial sunscreen.",
keywords = "Former Faculty of Pharmaceutical Sciences",
author = "Tue S{\o}borg and Basse, {Line Hollesen} and Bent Halling-S{\o}rensen",
year = "2007",
doi = "10.1016/j.tox.2007.04.011",
language = "English",
volume = "236",
pages = "140--148",
journal = "Toxicology",
issn = "0300-483X",
publisher = "Elsevier Ireland Ltd",
number = "1-2",

}

RIS

TY - JOUR

T1 - Risk assessment of topically applied products

AU - Søborg, Tue

AU - Basse, Line Hollesen

AU - Halling-Sørensen, Bent

PY - 2007

Y1 - 2007

N2 - The human risk of harmful substances in semisolid topical dosage forms applied topically to normal skin and broken skin, respectively, was assessed. Bisphenol A diglycidyl ether (BADGE) and three derivatives of BADGE previously quantified in aqueous cream and the UV filters 3-BC and 4-MBC were used as model compounds. Tolerable daily intake (TDI) values have been established for BADGE and derivatives. Endocrine disruption was chosen as endpoint for 3-BC and 4-MBC. Skin permeation of the model compounds was investigated in vitro using pig skin membranes. Tape stripping was applied to simulate broken skin associated with various skin disorders. BADGE and derivatives had a tendency to permeate pig skin membranes in vitro with higher fluxes in the tape stripped membranes compared to the non-treated membranes. Data from the in vitro skin permeation study and from the literature were used as input parameters for estimating the risk. The immediate human risk of BADGE and derivatives in topical dosage forms was found to be low. However, local treatment of broken skin may lead to higher exposure of BADGE and derivatives compared to application to normal skin. 3-BC permeated skin at higher flux than 4-MBC. Both UV filters are endocrine disrupting compounds with 3-BC being the more potent. UV filters in sunscreen are often present in high concentrations, which potentially may lead to high systemic exposure dosages. Thus, the risk associated with use of 3-BC and 4-MBC containing sunscreen with regards to endocrine disrupting effects was found to be high and more data is urgently needed in order to fully assess the human risk of 3-BC and 4-MBC in commercial sunscreen.

AB - The human risk of harmful substances in semisolid topical dosage forms applied topically to normal skin and broken skin, respectively, was assessed. Bisphenol A diglycidyl ether (BADGE) and three derivatives of BADGE previously quantified in aqueous cream and the UV filters 3-BC and 4-MBC were used as model compounds. Tolerable daily intake (TDI) values have been established for BADGE and derivatives. Endocrine disruption was chosen as endpoint for 3-BC and 4-MBC. Skin permeation of the model compounds was investigated in vitro using pig skin membranes. Tape stripping was applied to simulate broken skin associated with various skin disorders. BADGE and derivatives had a tendency to permeate pig skin membranes in vitro with higher fluxes in the tape stripped membranes compared to the non-treated membranes. Data from the in vitro skin permeation study and from the literature were used as input parameters for estimating the risk. The immediate human risk of BADGE and derivatives in topical dosage forms was found to be low. However, local treatment of broken skin may lead to higher exposure of BADGE and derivatives compared to application to normal skin. 3-BC permeated skin at higher flux than 4-MBC. Both UV filters are endocrine disrupting compounds with 3-BC being the more potent. UV filters in sunscreen are often present in high concentrations, which potentially may lead to high systemic exposure dosages. Thus, the risk associated with use of 3-BC and 4-MBC containing sunscreen with regards to endocrine disrupting effects was found to be high and more data is urgently needed in order to fully assess the human risk of 3-BC and 4-MBC in commercial sunscreen.

KW - Former Faculty of Pharmaceutical Sciences

U2 - 10.1016/j.tox.2007.04.011

DO - 10.1016/j.tox.2007.04.011

M3 - Journal article

C2 - 17499903

VL - 236

SP - 140

EP - 148

JO - Toxicology

JF - Toxicology

SN - 0300-483X

IS - 1-2

ER -

ID: 2307232