Reaction mass of L-valine and ethanesulphonic acid and octadecan-1-ol and docosan-1-ol and eicosan-1-ol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25/4/18 - 1/6/18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Good clinical practices (GCP) statement

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

method available in study report

GLP compliance:

no

Remarks:

GCP compliance

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of L-valine and ethanesulphonic acid and octadecan-1-ol and docosan-1-ol and eicosan-1-ol

Cas Number:

2125692-22-8

Molecular formula:

C25-31H54-66NO5S

IUPAC Name:

Reaction mass of L-valine and ethanesulphonic acid and octadecan-1-ol and docosan-1-ol and eicosan-1-ol

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 112
- Sex: male and female
- Age: between 19 and 70
- Race: no data
- Demographic information: no data
- Other:
in generally good health, were selected for the study (Subject Demographics – Appendix I). Subjects who met all of the inclusion criteria and none of the exclusion criteria listed in the study protocol were enrolled for participation.
a. Subject is male or female between the ages of 18 and 70 years;
b. Female subjects who are sexually active are using adequate method of birth control;
c. Subject does not exhibit any skin diseases which might be confused with a skin reaction from the test material;
d. Subject agrees to avoid exposure of the test sites to the sun and to refrain from visits to tanning salons during the course of this study;
e. Subject agrees to refrain from getting patches wet and from scrubbing or washing the test area with soap or applying powder, lotions or personal care products to the area during the course of the study;
f. Subject has signed an Informed Consent in conformance with 21CFR Part 50: “Protection of Human Subjects;”
g. Subject has completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
h. Subject is in generally good health and has a current Subject Profile on file;
i. Subject is dependable and able to follow directions as outlined in the protocol.
EXCLUSION CRITERIA
a. Subject is pregnant, nursing, or planning to become pregnant, or not using adequate birth control;
b. Subject is currently using any systemic or topical corticosteroids, anti-inflammatory drugs, or antihistamines on a regular basis;
c. Subject reports allergies to cosmetics, toiletries, or personal care products;
d. Subject exhibits any skin disorders, sunburn, scars, excessive tattoos, etc. in the test area;
e. Subject has scheduled, or is planning to undergo, any medical or surgical procedures during the 6-week course of the study.

Clinical history:

The subjects did not exhibit any physical or dermatological condition that would have precluded application of the test article

Route of administration:

dermal

Details on study design:

8.0 TEST METHOD SUMMARY
8.1 SUBJECT IDENTIFICATION
All subjects were initially identified by a permanent identification number. Subjects who met the qualification criteria were assigned a study subject number. This subject number was assigned in sequence as subjects were enrolled in the study. A master roster was kept of the permanent identification number and the corresponding study subject number.
8.2. INDUCTION PHASE
Informed Consent was obtained, Inclusion/Exclusion criteria verified and qualified subjects were enrolled. The test site was cleansed with 70% isopropyl alcohol. The test material was applied to the upper back, between the scapulae and the waist, to either side of the spinal midline. The test material was applied to the same site three times each week, usually Monday, Wednesday, and Friday, for a total of nine applications. However, the schedule may have been modified to accommodate inclement weather, holidays, or missed applications. At the discretion of the Principal Investigator, the test material may have been applied on two consecutive days during the Induction Phase or a makeup day may have been added at the end of the Induction Phase.
8.0 TEST METHOD SUMMARY (CONTINUED)
The test product was applied nine times over the approximate three-week induction phase. Subjects had no fewer than eight subsequent evaluations unless requested by the Sponsor.
The test site was marked with a gentian violet surgical marker to ensure the continuity of patch application. The subjects were instructed to remove the patch after 24 hours of exposure. An evaluation of the site was made just prior to the application of the next patch for signs of dermal reactions, according to the scoring scale listed in Section 7.0.
Rest periods consisted of 24 hours following Tuesday and Thursday patch removal and 48 hours following the Saturday patch removal, except when the schedule was modified as described above.
If at any time during the Induction Phase of the study, a test material elicited a score of 2+ or greater, the application of that test material was moved to an adjacent virgin site. At the discretion of the Principal Investigator or designee, a test material eliciting a score less than a 2+ may have been moved to an adjacent site. The site may also have been changed if the subject exhibited abrasion, maceration of the skin or tape reaction around the site.
If a 2+ reaction or greater occurred on the changed site, the application of the test material may have been discontinued for the remainder of the Induction Phase, but may have been challenged on the appropriate day of the study.
At the discretion of the Principal Investigator or designee, subjects exhibiting a significant reaction at the beginning of the Induction Phase may have been considered “pre-sensitized” to an ingredient(s) of the test product and may have been discontinued from the patching of that test material for the remainder of the study.
8.3. CHALLENGE PHASE
Approximately 10 to 21 days after the Induction Phase, a challenge patch was applied to a virgin site on the lower back, following the same procedure described for the Induction Phase. After 24 hours, the patch was removed by a study technician and the site was evaluated for dermal irritation.
Additional dermal evaluations were performed 48 and 72 hours after application. If a reaction with a dermal score of greater than “±” persists at the 72-hour reading, the site may have been evaluated at 96 hours. A site exhibiting a dermal score of “±” or greater for the first time at the 72-hour reading was evaluated at 96 hours when possible.
8.0 TEST METHOD SUMMARY (CONTINUED)
If a subject missed a visit during the Challenge Phase, he/she was asked to return to the laboratory for a 96-hour reading to ensure three data points were collected. Subjects having only 2 challenge phase data points may have been included in the analysis if the final visit was at the 72 or 96-hour time point. Dermal Irritation was graded using the scoring scale listed in Section 7.0.

Results and discussion

Results of examinations:

9.1. COMPLETED AND DISCONTINUED SUBJECTS
This study was initiated with 112 subjects. Twelve subjects discontinued study participation for reasons unrelated to the test material. A total of 100 subjects completed the study.
9.2. DERMAL EVALUATIONS
Individual dermal scores recorded during the Induction and Challenge Phases appear in Table I.
9.3. ADVERSE EVENTS
No adverse events were reported during the study.
10.0 CONCLUSION
Based on the test population of 100 subjects and under the conditions of this study, the test material identified as Aminosensyl did not demonstrate a potential for eliciting dermal irritation or inducing sensitization.

Applicant's summary and conclusion

Conclusions:

Based on the test population of 100 subjects and under the conditions of this study, the test material identified as Aminosensyl did not demonstrate a potential for eliciting dermal irritation or inducing sensitization.