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EC number: 947-393-3 | CAS number: -
According to clinical study (human repeat patch test) test item was considered as non-irritating and non-sensitising.
Table 7.10.4/1: Induction phase – results
% of subjects - reaction
* Subjects no. 104, 105, 106, 107 and 108 began the study 2 days later, so they did not have any visit at Day 5, Day 12 and Day 19, but at Day 6, Day 13 and Day 20.
** Additional application day for subjects no. 3, 13, 67, 69, 89, 95, 97 and 103 as they did not have any application nor reading performed one day during the induction phase.
Table 7.10.4/2: Challenge phase – results
H: homolateral site;C: contralateral site
* Subjects no.104, 105, 106, 107 and 108 began the study2days later, therefore their challenge phase was performed on Day34,Day 36,Day37and Day38 instead of Day36, Day38,Day39 and Day 40.
A cutaneous tolerance and sensitizing potential study of the investigational product, PATCHOULI FRACTION (ALPHA GUAIENE) 290737 8% (3646µg/cm2) EtOH/DEP(25/75) lot 1928083 tested undiluted was conducted by patches application, according to the Marzulli-Maibach sensitization method. The data of 102 female and male subjects aged from 19 to 63 years old were analyzed during the study. The subjects were willing and able to give a written informed consent. The study was carried out at the clinical unit of Skopje in MACEDONIA. The study was blinded and randomized.
Duration:Induction phase: 3 weeks (3 times a week during 48 hours or 72 hours); Duration Resting phase: 14 days; Challenge phase: 1 week (once during 48 hours)
INDUCTION PHASE: During the Induction Phase, the investigational product was applied (160 µL) on a predetermined site under semi occlusive patch (back). A semi-occlusive patch receiving no product was applied in the same conditions and was considered as a non-treated control. Each time, the patches (treated and non-treated) remained applied during 48 or 72 hours before removal and replaced on the same site.
RESTING PHASE: During the 14-day Resting Phase, no product was applied on the sites used during the Induction phase or on the contralateral split-back which was used during the Challenge phase.
CHALLENGE PHASE: During the challenge phase (Day 34/36*), the investigational product was applied under semi occlusive patch on the induction sites and on the contralateral sites. A semi occlusive patch receiving no product was applied in the same conditions and was considered as a non-treated control. The patches (treated and non-treated) remained applied during 48 hours and removed afterwards.
A clinical examination was performed by the investigating dermatologist during the Induction Phase on Days 1, 3,5/6,8, 10,12/13,15, 17,19/20and22/24,and during the Challenge Phase on Days34/36, 36/38, 37/39and38/40.
During the induction phase, no sign was observed on the control site and the investigational product site. During the challenge phase, no sign was observed on the control site and on the investigational product site, neither on the homolateral side nor on the controlateral site. In this study, no adverse event or serious adverse event was observed by the investigating dermatologists. No significant clinical manifestation of intolerance or allergy was observed by the investigator. The investigational product presents an irritation index of: Z = 0.000; the investigational product is therefore considered as practically non-irritant.
Under the conditions of the study, the investigational product PATCHOULI FRACTION (ALPHA GUAIENE) 290737 8% (3646 µg/cm2) EtOH/DEP(25/75) lot 1928083 tested undiluted, under semi occlusive patch, can be considered as non-sensitizing.
Under the conditions of the study, the investigational product PATCHOULI FRACTION (ALPHA GUAIENE) tested undiluted, under semi occlusive patch, can be considered as non-sensitizing.
In a human repeat insult patch test, the test item was concluded to be non-irritating and non-sensitising.
Based on this result and due to the nature of the main constituents of the registered substance, the registered substance does not need to be classified as skin sensitiser.
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