Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD Environmental Health and Safety Publications, Series on Testing and Assessment no. 28. Guidance document for the conduct of skin absorption studies (March 2004)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD Guidance Notes on Dermal absorption, Series on Testing and Assessment No. 156 (18 August 2011).
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: European Commission Guidance Document on Dermal Absorption – Sanco/222/2000/Rev. 7 (19 March 2004)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
L060

Description: White powder
Batch: PS03.3
Purity/Composition: 99.4%
Test substance storage: At room temperature in the dark

[14C]-L060
Batch: CFQ42087
Radiochemical purity: 99% (HPLC)
Chemical purity: 100% (HPLC)
Test substance storage: In freezer (≤ -15°C) in the dark
Specific activity: 334 MBq/mmol
Total activity: 37 MBq
Supplier: Quotient Bioresearch Ltd, The Old Glassworks, Nettlefold Road, Cardiff, CF24 5JQ, UK
The radiochemical purity was determined by the supplier and was also verified at WIL Research Europe at the start and at the end of the study.
Radiolabelling:
yes

Test animals

Species:
human

Administration / exposure

Vehicle:
water

Results and discussion

Any other information on results incl. tables

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 total recovery of radioactivity for the individual skin samples was within 100 ±10%, which is according to the OECD guidelines.

The potential dermal absorption was calculated without inclusion of the first two tape strips as recommended in the guidance documents. 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.

Applicant's summary and conclusion

Conclusions:
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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