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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.