2-hydroxybenzoic acid 2-butyloctyl ester

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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

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)

Type of study:

patch test

Justification for non-LLNA method:

The testing was completed on 30 January 2009. The LLNA 429 was not formally adopted by the OECD until July 2010.

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

In vivo test system

Test animals

Species:

human

Strain:

other: not applicable

Sex:

male/female

Details on test animals and environmental conditions:

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.

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, semiocclusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

100%

Challenge

Route:

epicutaneous, semiocclusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

100%

No. of animals per dose:

52 participants completed the study

Details on study design:

Test Material Preparation:

The test material was applied neat (undiluted).

Application Area:

The upper back between the scapulae served as the treatment area. Approximately 0.2 ml of the test material, or an amount sufficient to cover the contact surface, was applied to a 1 inch x 1 inch absorbent pad portion of a clear adhesive bandage. This was then applied to the appropriate treatment site to form a semi-occlusive patch.

Induction Phase:

Patches were applied 3 times weekly (e.g., Monday, Wednesday and Friday) for a total of 9 applications. Following supervised removal and scoring of the first induction patch, participants were instructed to remove all subsequent induction patches at home, twenty-four hours after application. Site evaluations were performed prior to re-application.

Challenge Phase:

Approximately 2 weeks after induction patch applications, a challenge patch was applied to a virgin (untreated) site adjacent to the original induction patch applications. The challenge patches were removed and the sites scored at the clinic 24 and 72 hours after applications.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Group:

positive control

Remarks on result:

not measured/tested

Results 2

Group:

negative control

Remarks on result:

not measured/tested

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

undiluted

No. with + reactions:

0

Total no. in group:

52

Clinical observations:

No positive reactions for irritation or allergic contact sensitization.

Results 4

Reading:

2nd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

undiluted

No. with + reactions:

0

Total no. in group:

52

Clinical observations:

No positive reactions for irritation or allergic contact sensitization.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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