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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Published data

Data source

Reference
Title:
Human in vivo percutaneous absorption of Pyrethrin and Piperonyl Butoxide
Author:
Wester, R.C., Bucks, D.A.W., Maibach, H.I.
Year:
1994
Bibliographic source:
Food Chem Toxicol. 32, 51-53

Materials and methods

Principles of method if other than guideline:
The dermal absorption of the active substance applied with a formulation containing 3% Piperonyl butoxide was studied by Wester et al.(1994)
14C-labelled Piperonyl butoxide (3.4 mCi/mmol - equivalent to a dose of 75.8 µg Piperonyl butoxide/ cm²) was applied to the ventral forearms of six human volunteers .
Percutaneous absorption was determined by 14C urinary excretion.
The forearms were thoroughly cleaned with soap and water 30 minutes after application. Percutaneous absorption was determined by urinary cumulative excretion of the 14C-radiolabel following application of the above dose.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Piperonyl butoxide
IUPAC Name:
Piperonyl butoxide
Details on test material:
14C-labelled Piperonyl butoxide (3.4 mCi/mmol
Radiolabelling:
yes

Test animals

Species:
human
Sex:
male

Administration / exposure

Type of coverage:
not specified
Vehicle:
other:
Doses:
3.4 mCi/mmol - equivalent to a dose of 75.8 µg Piperonyl butoxide/ cm²
No. of animals per group:
6 male volunteers
Control animals:
no
Details on study design:
100 µl of a formualtion containing pyridine and piperonyl butoxide were applied to the foreamr (44cm²)

Results and discussion

Signs and symptoms of toxicity:
not specified
Dermal irritation:
not specified
Absorption in different matrices:
no data
Total recovery:
no data
Percutaneous absorption
Dose:
75.8 µg/ cm²
Parameter:
percentage
Absorption:
2.1 %
Remarks on result:
other: 24 h
Conversion factor human vs. animal skin:
no applicable

Any other information on results incl. tables

Dermal absorption of Piperonyl butoxide was determined to be 2.1±0.6% of the dose applied to ventral forearm skin of six male volunteers. The calculated half-life for14C excretion of Piperonyl butoxide was 32 h.

Applicant's summary and conclusion

Conclusions:
Dermal absorption was 2.1% in a human volunteer study.
Executive summary:

The dermal absorption of the active substance applied with a formulation containing 3% Piperonyl butoxide was studied by Wester et al.(1994) who applied 14C-labelled Piperonyl butoxide (3.4 mCi/mmol - equivalent to a dose of 75.8 µg Piperonyl butoxide/ cm2) to the ventral forearms of six human volunteers .

The forearms were thoroughly cleaned with soap and water 30 minutes after application. Percutaneous absorption was determined by urinary cumulative excretion of the 14C-radiolabel following application of the above dose.

In this study the dermal absorption of Piperonyl butoxide was determined to be 2.1±0.6% of the dose applied to ventral forearm skin. The calculated half-life for 14C excretion of Piperonyl butoxide was 32 h.