Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Available as short summary from secondary source

Data source

Reference
Reference Type:
secondary source
Title:
The excretion and tissue distribution of [14C]-p-methylanisole in the rat after topical application. Report to RIFM.
Author:
D.R. Hawkins, B.C. Mayo, A.d. Pollard and W.W. Donschak
Year:
1993
Bibliographic source:
cited in the RIFM/FEMA database; Location 21041

Materials and methods

Principles of method if other than guideline:
Assessment of excretion and tissue distribution of radioactive p-methylanisole after topical application in the rat
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (14)C-p-methylanisole
Radiolabelling:
yes
Remarks:
(14)C-p-methylanisole

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: diethyl phthalate
Duration of exposure:
6 hours
Doses:
- Nominal doses: 100, 320 & ca. 1000 mg/kg bw
No. of animals per group:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
Dressing & residual dose were removed using cotton wool swabs moistened with diethyl phthalate.

SAMPLE COLLECTION
Urine, faeces & expired air were collected for 72 hours after dose application. At this time, rats were killed & whole blood & tissues were taken for measurement of radioactivity.

Results and discussion

Signs and symptoms of toxicity:
not specified
Dermal irritation:
not specified
Total recovery:
Radioactivity recovered from each group of rats dosed accounted for means of about 94-97% of the (14)C-p-methylanisole administered.
Percutaneous absorptionopen allclose all
Dose:
100 mg/kg bw
Parameter:
percentage
Absorption:
ca. 23 %
Remarks on result:
other: 72 hours
Remarks:
No data available given for whole blood/tissues
Dose:
320 mg/kg bw
Parameter:
percentage
Absorption:
ca. 35 %
Remarks on result:
other: 72 hours
Remarks:
No data available given for whole blood/tissues
Dose:
1000 mg/kg bw
Parameter:
percentage
Absorption:
ca. 57 %
Remarks on result:
other: 72 hours
Remarks:
No data available given for whole blood/tissues

Any other information on results incl. tables

1000 mg/kg bw:  

Total excretion via urine: 20% of dose

Total excretion via feces: 0.05-0.17% of dose

Radioactivity in expired air: 37% of dose

Recovery from washings of treated skin after 6 hours: 36% of dose

320 mg/kg bw:  

Total excretion via urine: 12% of dose

Total excretion via feces: 0.05-0.17% of dose

Radioactivity in expired air: 23% of dose

Recovery from washings of treated skin after 6 hours: 59% of dose

100 mg/kg bw:  

Total excretion via urine: 12% of dose

Total excretion via feces: 0.05-0.17% of dose

Radioactivity in expired air: 11% of dose

Recovery from washings of treated skin after 6 hours: 74% of dose

At 72 hours after dosing 0.02-0.05% of the dose was in the treated skin taken from these rats after being killed.

Applicant's summary and conclusion