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What ultrasonic frequencies have been associated with the largest preclinical de

ID: 3478838 • Letter: W

Question

What ultrasonic frequencies have been associated with the largest preclinical demonstrations of an increase skin permeability for hydrophilic solutes?

a.

10-100 Hz

b.

16-20 kHz

c.

1-3 Mhz

d.

10-16 MHz

e.

1-3 GHz

Which of the following is(are) preclinical methods for estimating risk of irritant contact dermatitis (ICD)?

I. Murine Local Lymph Node Assay (LLNA)

II. Direct Peptide Reactivity Assay (DPRA)

III. Il-1 release in cultured human keratinocytes, e.g. EpiDerm system

a.

I only

b.

III only

c.

I and II

d.

II and III

e.

I, II and III

Which of the following preclinical assays would be acceptable for cosmetic product development according to the principles of the 7th Amendment to the EU Cosmetics Directive?

Direct Peptide Reactivity Assay (DPRA)

Il-1 release from cultured human keratinocytes

Murine Local Lymph Node Assay (LLNA)

a.

I only

b.

III only

c.

I and II

d.

II and III

e.

I, II and III

a.

10-100 Hz

b.

16-20 kHz

c.

1-3 Mhz

d.

10-16 MHz

e.

1-3 GHz

Explanation / Answer

1. The ultrasonic frequencies that have been associated with the largest preclinical demonstrations of an increase skin permeability for hydrophilic solutes are 16-20 KHz. Low frequency ultrasound at 20 kHz are reported to be up to 1000 times more efficient at enhancing drug delivery than higher frequencies (1 – 3 MHz).

2. e

All three methods can be used for estimating risk of irritant contact dermatitis (ICD)

3. c

The principles of the 7th Amendment to the EU Cosmetics Directive included non testing of cosmetic products on animals. Therefore only Direct Peptide Reactivity Assay (DPRA) and Il-1 release from cultured human keratinocytes can be used as per 7th Amendment to the EU Cosmetics Directive as LLNA includes the use of murine, thus cannot be used.

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