Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
The sensitisation potential of the test item was assessed on 25 healthy male and female volunteers by application on the volar forearm or back for 5 alternate-days for a period of 48 hour. The patch site was pre-treated for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10-day rest period, a challenge patch of the test material was applied to a different site for a 48 hours under occlusion. The challenge site was read at patch removal and 24 hours thereafter.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl enantate
EC Number:
203-382-9
EC Name:
Ethyl enantate
Cas Number:
106-30-9
Molecular formula:
C9H18O2
IUPAC Name:
ethyl heptanoate

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed:
25 healthy male/female adult volunteers
- age: 18-47 years
Route of administration:
dermal
Details on study design:
ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: petrolatum
- Concentrations: 8%
- Other: treatment 48h

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 alternate-days
- Exposure period: 48 hours
- Test groups: 25 healthy male and female volunteers
- Pre-treatment: 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion
- Site: volar forearm or back

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 25 healthy male and female volunteers
- Evaluation (hr after challenge): immediately and after 24 hours

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions 0

RESULT OF CASE REPORT: no indication of skin sensitization after 48 and 72 h

Applicant's summary and conclusion

Conclusions:
There were no skin sensitisation reactions observed.
Executive summary:

In the current study a human maximization test was conducted on 25 healthy male and female volunteers with an age between 18 - 47 years old. The test material in petrolatum was applied on the volar forearm of all subjects for 5 alternate-days for a period of 48 hour. The patch site was pre-treated for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion.

Following a 10-day rest period, a challenge patch of the test material was applied to a different site for a 48 hours under occlusion. The challenge site was read at patch removal and 24 hours thereafter.

No sensitization reactions were produced with the test item at 8% in petrolatum.