Registration Dossier

Administrative data

Description of key information

Human Repeated Insult Patch Test (FDA-US), 100 humans tested (m+f, general poulation), no signs of irritation and sensitization (Klimish 1)
Human Repeated Insult Patch Test (FDA-US), 111 humans tested (m+f, general polulation), no signs of irritation and sensitization (Klimish 1)
Human Maximisation Test (no official guideline followed), 25 humans tested (f, 18-32 years old), no signs of irritation (Klimish 4)

Additional information

Human Repeated Insult Patch Test studies (HRIPT) is a study that can detect weak sensitizers that require multiple applications to induce a cell-mediated (Type IV) immune response sufficient to cause an allergic reaction. HRIPT isa reproducible, standardized, quantitative patch evaluation procedure generally accepted to demonstrate that a particular material can be applied safely to human skin without significant risk of adverse reactions.

Two HRIPTs covering the composition range of the substance were performed using a minimum of 100 appropriate human subjects (male + female, general population). There were no deviations from the test guideline (US-FDA) and both tests were selected as key study.

Under the conditions employed in this study, there was no evidence of both sensitization and irritation of the substance, even in rough test conditions, as occlusive testing is a severe condition improving dermal exposure & penetration, therefore facilitating dermal reactions.

A synopsis of a Human Maximization test performed on 25 people with the substance confirms the result of the HRIPTs.

 

In conclusion, the substance can be applied safely, at least to the concentration tested in that studies (20%), to human skin without significant risk of adverse reactions. 

 

Table 1: Human Skin sensitization studies

Test Guideline

Test concentrations

N° of humans/

dose

Klimishcode

Result

HRIPT

20% in DEP

100 (m+f)

1

Not sensitizing in humans

HRIPT

20% in DEP/EtOH

111 (m+f)

1

Not sensitizing in humans

Human Maximization Test

10 % in withe petrolatum

25 (f)

4

Not sensitizing in humans

HRIPT: Human Repeated Insult Patch Test

DEP: DiethylPhtalate

EtOH: Ethanol

m/f: male/female