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Specific investigations: other studies

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Reference
Endpoint:
specific investigations: other studies
Remarks:
dermal sensitization
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
8 October 2018 to 16 November 2018
Type of method:
other: clinical
Endpoint addressed:
skin irritation / corrosion
skin sensitisation
Specific details on test material used for the study:
2.5% in EtOH/DEP (1:3 w/w)
Route of administration:
dermal
Vehicle:
other: EtOH/DEP at 1:3 w/w
Details on exposure:
The study consisted of an induction phase, a challenge phase, and, at the discretion of the Principal Investigator and at the approval of the Sponsor, a Re-Challenge Test. During the Induction Phase, the test materials were applied to the same location on the back of each subject three times per week for a total of nine applications, with 24-hour rest periods, except Fridays, in between applications, or as specified in Section 10.0. Test sites were examined for dermal irritation at each visit prior to reapplication of the test materials. Approximately 10 to 21 days after the Induction Phase, subjects returned to the laboratory for the Challenge Phase. The test materials were applied to virgin sites on the back under the appropriate patch type, and were removed by clinic staff approximately 24 hours later. Test sites were examined for signs of dermal irritation or sensitization. At the discretion of the Principal Investigator and with the Sponsor’s approval, a subject may have been required to return to the lab for a Re-Challenge Test if reactions indicative of sensitization were observed during the Challenge Phase. During the Re-Challenge Phase, the test material was applied to a virgin site on the upper arm or back under the same conditions of the Challenge Phase and the subject was examined for dermal reactions. At the Sponsor’s request, additional products (“omission products” or individual components) may have been tested and/or other conditions may have been used.
Analytical verification of doses or concentrations:
no
Details on results:
This study was initiated with 112 subjects. Six subjects discontinued study participation for reasons unrelated to the test material. A total of 106 subjects completed the study.
No adverse events were reported during the study.
Conclusions:
Based on the test population of 106 subjects and under the conditions of this study, the test materials PG-RAW-0004 at 2.5% in EtOH/DEP (1:3 w/w) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.15ml of the test material applied to a 3.63 cm2 occlusive patch, which was equivalent to dermal dosage of approximately 1030 ug/cm2.
Executive summary:

One hundred and twelve subjects participated in evaluating the potential of PG-RAW-0004 (2.5% in EtOH/DEP 1:3w/w) to elicit dermal irritation and/or induce sensitization. The test material was applied under occlusive patch to the upper back of each subject and were allowed to remain in direct skin contact for a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. The sites were graded by a CRL technician for dermal irritation 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday.

Approximately 10 to 21 days after the Induction Phase, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours after application. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading.

One hundred and six subjects completed the study. The test material identified as PG-RAW-0004 (2.5% in EtOH/DEP 1:3w/w) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.15ml of the test material applied to a 3.63 cm2 occlusive patch, which was equivalent to dermal dosage of approximately 1030 ug/cm2.

Description of key information

One hundred and twelve subjects participated in evaluating the potential of PG-RAW-0004 (2.5% in EtOH/DEP 1:3w/w) to elicit dermal irritation and/or induce sensitization. The test material was applied under occlusive patch to the upper back of each subject and were allowed to remain in direct skin contact for a period of 24 hours. Patches were applied to the same site on Monday, Wednesday, and Friday for a total of 9 applications during the Induction Period. The sites were graded by a CRL technician for dermal irritation 24 hours after removal of the patches by the subjects on Tuesday and Thursday and 48 hours after removal of the patches on Saturday.

Approximately 10 to 21 days after the Induction Phase, challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed by a CRL technician and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours after application. Subjects exhibiting reactions during the Challenge Phase of the study may have been asked to return for a 96-hour reading.

One hundred and six subjects completed the study. The test material identified as PG-RAW-0004 (2.5% in EtOH/DEP 1:3w/w) did not demonstrate a potential for eliciting dermal irritation or sensitization under the following test conditions: 0.15ml of the test material applied to a 3.63 cm2 occlusive patch, which was equivalent to dermal dosage of approximately 1030 ug/cm2.

Additional information