Fatty acids, C16-18, 2-butyloctyl esters

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize test

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18, 2-butyloctyl esters

EC Number:

309-831-6

EC Name:

Fatty acids, C16-18, 2-butyloctyl esters

Cas Number:

101227-08-1

Molecular formula:

C28H56O2 - C30H60O2

IUPAC Name:

Fatty acids, C16-18, 2-butyloctyl esters

Test material form:

other: liquid

Method

Details on study design:

27 human volunteers, controls not required

TEST SITE
- Area of exposure: not mentioned
- % coverage: no data
- Type of wrap if used: occlusive patch, no further details mentioned

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done, however the patch sites were then wiped gently with a dry cotton ball
- Time after start of exposure: 48 h

SCORING SYSTEM:
see table #1 below

The subjects were infonned of the nature of the test, including possible adverse reactions. Written infonned consent was obtained.
Additionally, the subjects were considered dependable and able to read and understand instructions. The subjects did not exhibit any physical or dennatological condition that would have precluded application of the test article.
The subjects were requested to report to the testing facility any delayed reactions which might occur after the last reading. If necessary, readings were taken at additional time periods after application.

Details on exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 mL undiluted
Duration of treatment / exposure: 4 h
Observation period: 1 h and 48 h

Results and discussion

Results:

not irritating

Any other information on results incl. tables

Phase I and II: Transient, barely-perceptible (+) non-specific patch test responses were observed on I to 4 (1/27 to 4/27 or 3.6% to 14.2% of the test population) test panelists under the patch test conditions described for Phase I and Phase II of the study. None of these responses was considered evidence of clinically meaningful irritation potential.

Phase III: No skin reactivity was observed during the course of the study.

Applicant's summary and conclusion

Conclusions:

Erythema score (mean): 0
Oedema score (mean): 0


Under the patch test conditions described for Phases I, II and III of the study the test substance did not show any evidence of primary irritation potential in human subjects.

Executive summary:

Under the patch test conditions described for Phases I, II and III of the study the test substance did not show any evidence of primary irritation potential in human subjects.