2-(2-oxopyrrolidin-1-yl)butyramide

Dermal absorption

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 428 (Skin Absorption: In Vitro Method)

Deviations:

no

Test guideline 2

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: OECD Guidance Notes on Dermal absorption, Series on Testing and Assessment No. 156 (18 August 2011).

Deviations:

no

Test guideline 4

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.