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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Sensitisation data (human)

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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

Constituent 1
Chemical structure
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.