Benzyl propionate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Human Maximization Test (HMT), Kligman (1966) Journal of Investigative Dermatology, Vol. 47, No. 5, 393-409

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl propionate

EC Number:

204-559-3

EC Name:

Benzyl propionate

Cas Number:

122-63-4

Molecular formula:

C10H12O2

IUPAC Name:

benzyl propanoate

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 25
- Sex: male
- Age: 21-44
- Demographic information: inmate volunteers

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: occlusive
- Removal of test substance: 24 hours rest period between removal and reapplication of the patch
- Concentrations: no data

EXAMINATIONS
- Grading/Scoring system: challenge sites were read on removal of the patch and 24 hours thereafter

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions: 25/25

Any other information on results incl. tables

Since no subject had any irritation from the test material, it was decided to use sodium lauryl sulfate pre-treatment in the test.

Applicant's summary and conclusion

Conclusions:

No instances of contact-sensitization from the test material on the Human Maximization Test.

Executive summary:

The contact-sensitizing potential of the test material was determined in a Human Maximization Test (HMT) with 25 healthy male inmate volunteers. In a pre-experiment, five subjects were administered to normal sites on the backs for 48 hours under occlusion. No subject had any irritation from these materials and it was decided to use sodium lauryl sulfate pre-treatment in the test.

In the Maximization Test, the test material was applied under occlusion to the same sites on the volar forearms of all subjects for five alternate-day 48 hour periods. The patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate under occlusion. Following a ten-day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour applications of 10% aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter. In this Human Maximization Test, there were no instances of contact-sensitization from the test material.