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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Unpublished report which meets generally accepted scientific standards, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Investigation of the absorption, distribution and excretion of the substance after a single cutaneous dose.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
yes
Remarks:
14C

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 83-187 g

Administration / exposure

Type of coverage:
other: porous lids
Vehicle:
water
Duration of exposure:
once, for 72 hours
Doses:
6.68 mg/kg bw (0.1 mL)
No. of animals per group:
3
Control animals:
no
Details on study design:
On the day of the study the hair on the rats' back will be clipped with and Oster clipper. The area where the compound will be applied will be checked and only skin free from irritated tissue will be used.
The rats will be food-fasted overnight. The following morning the substance will be applied to the rats' backs. The rats will be dosed with 0.1 mL within two glass cells fitted with porous lids (10 cm2 total area).
The CO2 will be collected at 8-hour intervals and the urine and faeces will be collected for 24-hour intervals for the 72-hour test period.

Results and discussion

Absorption in different matrices:
When the substance was dosed cutaneously, most of the 14C was recovered at the test site. 94.6% of the 96.8% 14C recovered was on the skin, indicating very little absorption of the compound. Less than 0.1% of the dosed radioactivity was found in the tissues, carcass, urine and faeces. This percentage is so small that it may represent either the test compound or radiochemical impurities present in the dosing preparation.
The recovery was excellent with 96.8% of the dosed 14C accounted for.

Applicant's summary and conclusion