Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
GLP compliance:
yes

Test material

Constituent 1
Test material form:
other: L060 was tested as a radioactive powder and aqueous dilution (500g L060/L).
Details on test material:
L060 was tested as a radioactive powder and aqueous dilution (500g L060/L).
Radiolabelling:
yes
Remarks:
L060 was tested as a radioactive powder and aqueous dilution (500g L060/L).

Administration / exposure

Type of coverage:
other: Production is performed on fresh skin obtained from cosmetic surgery
Vehicle:
water
Duration of exposure:
exposure (approx.1.5 h) at room temperature.

Results and discussion

Signs and symptoms of toxicity:
not examined
Dermal irritation:
not examined
Absorption in different matrices:
The mean percentage potentially absorbable was 0.31 ± 0.42% for the
powder formulation and 0.26 ± 0.33% for the aqueous dilution.
Total recovery:
The mean recovery of radioactivity was 97 ± 2%

Any other information on results incl. tables

See study report

Applicant's summary and conclusion

Conclusions:
The mean in vitro dermal absorption was low in terms of percentage with values of 0.31 ± 0.42% for the powder formulation and 0.26 ± 0.33% for the aqueous dilution.
Executive summary:

In this study the dermal absorption of [14C]-L060 was investigated using human skin in vitro. L060 was tested as radioactive powder and aqueous dilution (500 g L060/L). One group of 12 human skin discs (7 different donors) was exposed to the L060 powder test formulation mixed with [14C]-L060 for 8 hours under non-occlusion conditions. A second group of 10 human skin discs (6 different donors) was exposed to the L060 aqueous dilution mixed with [14C]-L060 (corresponding to 500 g L060/L) for 8 hours under non-occlusion conditions. The mean recovery of radioactivity was 97 ± 2% for the skin discs exposed to the powder formulation and 96 ± 2% for the skin discs exposed to the aqueous dilution (500 g L060/L). The mean in vitro dermal absorption was low in terms of percentage with values of 0.31 ± 0.42% for the powder formulation and 0.26 ± 0.33% for the aqueous dilution. The in vitro maximum flux of L060 through human skin was 1.14 ± 2.42 μg/cm2/h for the powder formulation and 0.73 ± 0.94 μg/cm2/h for the aqueous dilution.