Octanal

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

13 April 1964 to 9 October 1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Extensive human volunteer study giving negative results and supporting the conclusions of several animal models, but details of the study design and methods involved in the HRIPT are limited given the age of the study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1964

Report date:

1964

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: The method was a modification of the Draize test published in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, 1959.

Principles of method if other than guideline:

Human volunteer repeat insult patch test to determine irritative or sensitising potential. The method was a modification of the Draize test published in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, 1959.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octanal

EC Number:

204-683-8

EC Name:

Octanal

Cas Number:

124-13-0

Molecular formula:

C8H16O

IUPAC Name:

octanal

Constituent 2

Reference substance name:

SC-1279-A

IUPAC Name:

SC-1279-A

Test material form:

other: odorous liquid

Details on test material:

No details provided

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 44 started the study and 41 completed
- Sex: 9 males and 32 females
- Age: males in range of 16 to 50 and females in range 16-60
- Race: no data
- Demographic information: no data

Clinical history:

No information

Controls:

No details

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: An inch-square Webril (absorbent non-woven cotton fabric) patch covered by adhesive elastic bandage.
- Vehicle / solvent: no data
- Concentrations: no data
- Volume applied: 0.5 ml per patch
- Testing/scoring schedule: nine induction patches applied in three consecutive weeks (24 h applications on Mon, Wed and Fri), reactions scored after bandage removal. The challenge patch was applied in week 6 - 24 h semi-occluded application that was scored 48 and 96 hours after application
- Removal of test substance: No information
- Other: Initially ten subjects were placed on study and additional subjects comitted if no adverse reactions observed to bring up to about 40 subjects

EXAMINATIONS
- Grading/Scoring system: modified Draize system for erythema and oedema
- Statistical analysis: no information

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: No reactions observed

NO. OF PERSONS WITH REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions 41/41
- Number of subjects with equivocal reactions none
- Number of subjects with irritating reactions none

RESULT OF CASE REPORT:

OTHER RESULTS:

Applicant's summary and conclusion

Conclusions:

Octanal did not elicit any irritation reactions during the induction phase and no signs of skin sensitisation following challenge

Executive summary:

41 human volunteer subjects were exposed in nine induction applications to octanal over a 3 -week period and after approximately two weeks rest, the subjects were challenged under a 24 hour semi-occluded patch. No reactions were evident in any of the subjects during the induction and no reactions indicative of sensitisation were apparent following the challenge application.