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

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06/2009

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:

2009

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-isoleucine and octadecan-1-ol and ethanesulphonic acid and docosan-1-ol

EC Number:

931-105-8

Cas Number:

1156505-34-8

Molecular formula:

C26-30H56-64O5NS

IUPAC Name:

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

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 53
- Sex: male and female
- Age: between 18 and 70
- Race: no data
- Demographic information: no data
- Other:
Each subject was assigned a permanent CRL identification number. All subject signed an Informed
Consent Form in compliance with 21 CFR Part 50: "Protection of Human Subjects" and a HIPAA
Authorization Form in compliance with 45 CFR Part 160 and 164. All subject completed a Subject Prof
ile/Medical History Form provided by Clinical Research Laboratories, Inc. prior to the study (Subject
Demographics - Appendix I). Subject who met the following criteria were impaneled:
- Male and Female panelists between the ages of 18 and 70
- Subjects who have completed a Panelist Profile/Medical History
- Subjects who are in general good health as determined by a Panelist Profile/Medical History
- Subjects who do not exhibit any skin diseases that might be confused with a skin reaction from the
test material
- Subjets who agree to avoid exposure of the test sites to the sun and to refrain from visits to tanning
salons during the course of the study
- Subject willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: "Protection
of Human Subjects"
- Females who are not pregnant or lactating
- Subjects who demonstrate dependability and intelligence in following directions
- Subjects who are not currently using systemic or topical corticosteroids, anti-inflammatory drugs or
antihistamines
- Subjects who do not exhibit skin disorder, sunburn, scars, excessive tatoos, etc. in the test area

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:

See test method in report attached

Results and discussion

Results of examinations:

This study was initiated with 56 subjects. 3 subjects discontinued study participation for reasons
unrelated to the test material. A total of 53 subjects completed the study.
Individual dermal scores recorded during the Induction and Challenge Phase appear in table 1 (report
attached)

Applicant's summary and conclusion

Conclusions:

Based on the test population of 53 subjects and under the conditions of this study, the test material identified as 65% Brassicyl Isoleucinate Esylate, 35% Brassica Alcohol did not demonstrate a potential for eliciting dermal irritation or sensitization

Executive summary:

To determine the irritation and/or sensitization potential of the test article after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel).

The 9 Repeated Insult (semi-occlusive) Patch Test (9 RIPT) was conducted.

Based on the test population of 53 subjects and under the conditions of this study, the test material identified as 65% Bassicyl Isoleucinate Esylate, 35% Brassica Alcohol did not demonstrate a potential for eliciting dermal irritation or sensitization