Ethyl octanoate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Remarks:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1975

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The test has been performed on healthy adult volunteers without OECD or GLP guideline and it has been well conducted, however, the amount of substance tested is missing and the study report is limited.

Reason / purpose for cross-reference:

reference to same study

Type of sensitisation studied:

skin

Study type:

study with volunteers

Remarks:

25 male/females

Qualifier:

no guideline followed

Principles of method if other than guideline:

The patch site was pre-treated for 24 hours with 2.5% to 5% aqueous sodium lauryl sulfate under occlusion.

Induction: test substance at 2% in petrolatum under occlusion on 5 alternate-day 48 hour periods on the same site on the volar forearm or back of all subjects with a 24 hour rest period between removal and reapplication of the patch.

Challenge: occluded challenge patches were applied for 48 hours after a rest period of 10 - 14 days.
The reactions were read at the patch removal (after 48 h) and 24 hours after the patch removal (after 72 h) and the sensitisation index was noted.

GLP compliance:

no

Type of population:

not specified

Ethical approval:

not specified

Subjects:

25 male/female volunteers
Age varies from 18 to 39 years old

Route of administration:

dermal

Details on study design:

PRE-TREATMENT: 2.5 - 5 % sodium lauryl sulfate for 24h

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 alternate-day
- Site: volar forearms or back, under occlusion
- Duration exposure: 48h
- Duration between removal and re-application of the patch: 24h
- Concentrations: 2% in petrolatum

B. CHALLENGE EXPOSURE
- Rest period before the challenge: 10 - 14 days
- No. of exposures: 1
- Exposure period: 48h
- Site: same as induction, under occlusion
- Concentrations: 2% in petrolatum
- Evaluation: on removal of patch (48 h after challenge) and 24 h later (72 h after challenge)

Results of examinations:

No reactions were observed

Maximisation results

				challenge
Subject number	Age	Race	Sex	48-hours	72-hours
1	21	W	F	0	0
2	18	W	F	0	0
3	18	W	F	0	0
4	18	W	M	0	0
5	18	B	F	0	0
6	18	W	F	0	0
7	18	W	M	0	0
8	18	W	F	0	0
9	27	B	F	0	0
10	20	B	F	0	0
11	18	W	F	0	0
12	18	B	M	0	0
13	23	W	M	0	0
14	18	W	F	0	0
15	27	B	F	0	0
16	18	W	F	0	0
17	18	W	F	0	0
18	39	B	M	0	0
19	29	W	F	0	0
20	21	W	F	0	0
21	18	B	M	0	0
22	30	W	F	0	0
23	29	W	M	0	0
24	26	B	M	0	0
25	39	W	M	0	0

Conclusions:

No reactions were observed

Executive summary:

A human maximisation study was conducted on 25 subjects with ethyl octanoate at 2% in petrolatum. Occluded applications were made for five alternate-day 48-hour periods to the forearms or backs, and the sites were pretreated for 24 hours with 2.5 - 5% aqueous sodium lauryl sulfate (SLS) under occlusion. The occluded challenge patches were applied for 48 hours after a rest period of 10 - 14 days. The reactions were read at the patch removal and 24 hours after the patch removal, however, no reactions were observed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In a pre-test for a human maximisation study, a 48 hour closed patch test on the forearms or backs of 25 healthy, male and female volunteers. Vehicle was petrolatum

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl octanoate

EC Number:

203-385-5

EC Name:

Ethyl octanoate

Cas Number:

106-32-1

Molecular formula:

C10H20O2

IUPAC Name:

ethyl octanoate

Method

Ethical approval:

not specified

Details on study design:

In a pre-test for a human maximisation study, a 48 hour closed patch test on the forearms or backs of 25 healthy, male and female volunteers, with ages ranging from 18 to 39 years old was performed. Vehicle was petrolatum.

Exposure assessment:

measured

Details on exposure:

INDUCTION EXPOSURE
- epicutaneous, occlusive
- No. of exposures: 1
- Site: volar forearms or back
- Duration exposure: 48h
- Concentrations: 2% in petrolatum

Results and discussion

Results:

The substance did not produced irritation in 25 volunteers.

Applicant's summary and conclusion

Conclusions:

The substance did not produced irritation in 25 volunteers and should not be considered as an irritant.

Executive summary:

Irritation was evaluated prior to a human maximisation study, and a 48-hour occluded patch test was conducted on the forearms or backs of 25 subjects with ethyl octanoate at 2% in petrolatum. No reactions were observed.