Diheptyl succinate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to GCP: Good Clinical Practice

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Type of sensitisation studied:

skin

Test guideline

Qualifier:

according to guideline

Guideline:

other: RIPT

Version / remarks:

GCP applied

Deviations:

no

Principles of method if other than guideline:

the purpose of this study is to determine the dermal irritation and sensitization potential of diheptyl succinate

GLP compliance:

no

Remarks:

Good Clinical Practice GCP

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl adipate

EC Number:

203-350-4

EC Name:

Dibutyl adipate

Cas Number:

105-99-7

Molecular formula:

C14H26O4

IUPAC Name:

1,6-dibutyl hexanedioate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Dibutyl adipate
- Analytical purity: no data

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 57
- 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 Profile/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 attached report

Results and discussion

Results of examinations:

This study was initiated with 57 subjects. 7 subjects discontinued study participation for reasons unrelated to the test material. A total of 50 subjects completed the study.
Individual dermal scores recorded during the Induction and Challenge Phase appear in table 1 (report attached)
Based on the test population of 50 subjects and under the conditions of this study, the test material identified as diheptyl succinate did not demonstrate a potential for eliciting dermal irritation or sensitization.

Applicant's summary and conclusion

Conclusions:

Based on the test population of 50 subjects and under the conditions of this study, the test material identified as diheptyl succinate 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).

Fifty-six (57) subjects, ranging in age from 18 to 70 years were impaneled for this test.

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

Based on the test population of 50 subjects and under the conditions of this study, the test material identified as diheptyl succinate did not demonstrate a potential for eliciting dermal irritation or sensitization