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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OTS 795.2280 (Oral/Dermal Pharmacokinetics)
Principles of method if other than guideline:
Radiolabeled 14C-Tributyl phosphate was administered to Yucatan minipigs by intravenous and dermal dose routes in order to investigate its absorption, distribution, and excretion in this species. Measurements of radioactivity were made in samples of feces, urine, bladder and kidney following intravenous and dermal application.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tributyl phosphate
EC Number:
204-800-2
EC Name:
Tributyl phosphate
Cas Number:
126-73-8
Molecular formula:
C12H27O4P
IUPAC Name:
tributyl phosphate
Details on test material:
purity: 98.7%, specific activity: 206.5 µCi/mg
Radiolabelling:
yes
Remarks:
14C-TBP

Test animals

Species:
other: Yucatan Minipig
Strain:
not specified
Sex:
male/female

Administration / exposure

Type of coverage:
other: dermal: occlusive
Vehicle:
other: dermal: neat iv: Emulphor/ethanol/water
Duration of exposure:
6 hours dermal
Doses:
iv: 5 mg/kg (single bolus)
dermal. 10 mg/kg or 350 mg/kg (6-hr exposure)
No. of animals per group:
2 males + 2 females/dose/group
Control animals:
no

Results and discussion

Percutaneous absorption
Remarks on result:
other: 14C-TBP is poorly absorbed across the skin of Yucatan Minipigs, is rapidly eliminated via the urine, and does not appear to bioaccumulate in the bladder or kidneys.
Conversion factor human vs. animal skin:
no data

Any other information on results incl. tables

Measurements of radioactivity were made in samples of feces, urine, bladder and kidney following intravenous and dermal application. Radioactive material was recovered at more than 80% for all dose groups except the low dose dermal groups where about 60% was recovered. 14C-TBP was rapidely eliminated via the urine and within the first 6 hr of intravenous exposure. The dermal doses were very poorly absorbed (maximum amount absorbed was about 5% of dose) and it was again eliminated mostly via the urine. There were no apparent sex differences in this study.

Applicant's summary and conclusion

Executive summary:

Radiolabeled 14C-Tributyl phosphate was administered to Yucatan minipigs by intravenous and dermal dose routes in order to investigate its absorption, distribution, and excretion in this species. Measurements of radioactivity were made in samples of feces, urine, bladder and kidney following intravenous and dermal application.

Radioactive material was recovered at more than 80% for all dose groups except the low dose dermal groups where about 60% was recovered. 14C-TBP was rapidely eliminated via the urine and within the first 6 hr of intravenous exposure. The dermal doses were very poorly absorbed (maximum amount absorbed was about 5% of dose) and it was again eliminated mostly via the urine. There were no apparent sex differences in this study.