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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Objective of study:
absorption
Principles of method if other than guideline:
Method: other: Draft OECD Guideline 428 skin absorption in vitro method
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Test animals

Species:
mouse

Administration / exposure

Vehicle:
water
Duration and frequency of treatment / exposure:
48 hour(s)

Results and discussion

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parametersopen allclose all
Toxicokinetic parameters:
half-life 1st:
Toxicokinetic parameters:
half-life 2nd:
Toxicokinetic parameters:
half-life 3rd:

Any other information on results incl. tables

Concentration: 65%, dose 7028 µg/cm2

Flux constant [µg cm-2 h-1]: 18.5 ± 13.0

Kp-value [cm h-1]: 0.026 ± 0.018

Lag time [h]: 0.1 ± 0.2

Relative skin absorption after 48 h: 13.9% 

 

Concentration: 20%, dose 1966 µg/cm2

Flux constant [µg cm-2 h-1]: 21.0 ± 13.6

Kp-value [cm h-1]: 0.107 ± 0.069 Lag time [h]: 0.2 ± 0.4

Relative skin absorption after 48 h: 40.9% 

 

Concentration: 1%, dose 94.6 µg/cm2

Flux constant [µg cm-2 h-1]: 0.61 ± 0.7

Kp-value [cm h-1]: 0.065 ± 0.074

Lag time [h]: 1.8 ± 0.4

Relative skin absorption after 48 h: 22.6% 

 

Concentration: 0.1%, dose 9.73 µg/cm2

Flux constant [µg cm-2 h-1]: 0.15 ± 0.12

Kp-value [cm h-1]: 0.151 ± 0.128

Lag time [h]: 1.3 ± 0.6

Relative skin absorption after 48 h: 43.6%

 

The amount of radioactivity on the skin after stripping was 5.3 to 17.6-fold lower than the amount of radioactivity in the receptor fluid. The mean recovery of radioactivity was between 91.2 and 102.2 %.

Applicant's summary and conclusion