2-hydroxybenzoic acid 2-butyloctyl ester

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 December 2008 to 30 January 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Although not stated, the procedure used was essentially that of Draize (Procedures for the appraisal of the toxicity of chemicals in foods, drugs, and cosmetics. VIII. Dermal toxicity, Food Drug Cosmetic Law J. 10:722-731, 1955).

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

431-090-3

EC Name:

-

Cas Number:

190085-41-7

Molecular formula:

C19 H30 O3

IUPAC Name:

2-butyloctyl 2-hydroxybenzoate

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

Fifty-six (56) male and female

Route of administration:

dermal

Details on study design:

Participants:

Fifty-six (56) male and female subjects ranging in age from 19 to 78 years of age. Fifty-two (52) subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.

Inclusion Criteria:

The following criteria applied to study participants: male and female, age 16 or older; an absence of any visible skin disease which might confuse the study results; prohibition on the use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation; completion of medical history forms and informed consent forms; considered reliable and capable of following directions.

Exclusion Criteria:

The following applied: ill health; someone under a doctor's care and taking medication that might influence the outcome of the study; pregnant or nursing females; a history of adverse reactions to cosmetics or other personal care products.

Results and discussion

Results of examinations:

Under the conditions of this study, the test material did not indicate a potential for dermal irritation or allergic contact sensitization.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the test material did not indicate a potential for dermal irritation or allergic contact sensitization.