Registration Dossier
Registration Dossier
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EC number: 446-640-8 | CAS number: -
Dermal absorption
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:
- 2 014
- 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
- 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).
Constituent 1
- 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.
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