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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
other: review
Rationale for reliability incl. deficiencies:
other: review

Data source

Referenceopen allclose all

Reference Type:
other: MAK review, 2012
Title:
Toxikologisch-arbeitsmedizinische Begründung von MAK-Werten: Butylhydroxytoluol (BHT), Nachtrag 2012
Author:
Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe der Deutschen Forschungsgemeinschaft
Year:
2012
Bibliographic source:
Wiley-VCH Verlag GmbH & Co. KGaA, ISSN 0930-1984
Reference Type:
other: MAK review, 2004
Title:
Toxikologisch-arbeitsmedizinische Begründung von MAK-Werten: Butylhydroxytoluol (BHT), Nachtrag 2004
Author:
Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe der Deutschen Forschungsgemeinschaft
Year:
2004
Bibliographic source:
Wiley-VCH Verlag GmbH & Co. KGaA, ISSN 0930-1984
Reference Type:
publication
Title:
Topical Pharmacokinetics of [14C] butylated hydroxytoluene in the guinea pig
Author:
Courtheoux, S., I.; et al.
Year:
1985
Bibliographic source:
Dermatology, 6, 153-164
Reference Type:
publication
Title:
Percutaneous absorption of 14C-butylated hydroxytoluene and 14-C malathion in the guinea pig: effect of repeated skin administration
Author:
Marty, J., P.; et al.
Year:
1984
Bibliographic source:
Biopharm. Pharmacokinet., Eur. Congr., 2nd, vol. 1, 272-281

Materials and methods

Principles of method if other than guideline:
other: pharmacokinetic study, dermal
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
yes

Test animals

Species:
guinea pig
Strain:
other: Dunkin Hartley and tricolor guinea pigs

Results and discussion

Percutaneous absorption
Dose:
in vitro
Parameter:
percentage
Absorption:
13.4 %
Remarks on result:
other: 24 h
Remarks:
Based on the above mentioned data MAK concluded that overall the dermal absorption rats is 13.4%. 2.3% is resobed in the in vitro rat skin test and 11.1% is retained in the skin, and might be theoretically available for absorption (MAK 2012). This value i
Conversion factor human vs. animal skin:
MAK concluded that overall the dermal absorption rats is 13.4%. 2.3% is resorbed in the in vitro rat skin test and 11.1% is retained in the skin, and might be theoretically available for absorption (MAK 2012).

Any other information on results incl. tables

After a single application of 5 mg 14C-labelled BHT in acetone to guinea pigs (1.66 mg BHT/cm2), 9.1% of the applied dose was detected in the urine and 5% in the faeces after 7 days. Total absorption was 8.5% after 8 days using the lipophilic solvent Labrafil instead of acetone. After 3 wk of daily dermal application of 5 mg BHT in Labrafil solution (1.66 mg/cm2) and three applications of 5 mg radioactiely labelled BHT on test days 1, 8, and 15, a total absorption of up to 9.1% was determined.

Applicant's summary and conclusion