Heptyl undec-10-enoate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11/2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Repeated Insult Patch Test

Deviations:

no

Principles of method if other than guideline:

To determine the irritation and/or sensitization potential of the test article after repeated application under semi-occlusive patch test conditions to the skin of human subjects

GLP compliance:

not specified

Remarks:

GCP: Good Clinical Practice

Test material

Test material information

Constituent 1

Reference substance name:

Heptyl undec-10-enoate

EC Number:

268-850-7

EC Name:

Heptyl undec-10-enoate

Cas Number:

68141-27-5

Molecular formula:

C18H34O2

IUPAC Name:

heptyl undec-10-enoate

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 51
- 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. 5 subjects discontinued study participation for reasons unrelated to the test material. A total of 51 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 51 subjects and under the conditions of this study, the test material identified as caprylohydroxamic acid did not demonstrate a potential for eliciting dermal irritation or sensitization.

Executive summary:

An RIPT test has been performed with material heptyl undecylenate. Based on the test population of 51 subjects and under the conditions of this study, the test material identified as caprylohydroxamic acid did not demonstrate a potential for eliciting dermal irritation or sensitization.