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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:
other: non conventional patch test with only one woman exposed, who presented allergic reaction to eau de toilette. The ethylvanillin tested was extracted from eau de toilette.

Data source

Reference
Reference Type:
publication
Title:
Identification of coumarin as the sensitizer in a patient sensitive to her own perfume but negative to the fragrance mix.
Author:
Mutterer V, Gimenez-Arnau E, Lepoittevin JP, Johansen JD, Frosch PJ, Menne T, Andersen KE, Bruze M, Rastogi SC and White IR
Year:
1999
Bibliographic source:
Contact Dermatitis, 40(4), 196-199

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was tested by the patient in a ROAT (Repeated Open Application Test), using 1 drop (25 µl) of an ethanolic solution of the test
material, applied openly 3 times a day to a 4 cm² use test site, elbow flexure right.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Ethylvanillin is issued from an eau de toilette that was chemically fractionned by flash column chromatography on silica gel.

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 1
- Sex: woman
- Age: 44 years old
- Race: no data
- Demographic information: no data
- Other: no data
Clinical history:
- History of allergy or casuistics for study subject or populations: woman with no previous problems developed an axillary rash using a perfumed deodorant. At the same time she started to use an eau de toilette of the same brand and developed a rash on the neck and on the trunk. The rash disappeared on treatment with topical corticosteroids for a few days. The patient started applying both products again and developed a generalized eczema.
- Symptoms, onset and progress of the disease: no data
- Exposure history: no data
- Aggravating factors both in home and workplace: no data
- Family history: no data
- Medical history (for respiratory hypersensitivity): no data
- Any other allergic or airway disorders: no data
- Smoking history: no data
- Other: no data
Controls:
10 consecutive eczema patients that were patched negative to the substance served as controls and did a 3-day ROAT with the substance in the manner similar to the patient.
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn Chambers on Scanpor tape.
- Vehicle / solvent: ethanol
- Concentrations: 1%
- Volume applied: 0.15 g
- Testing/scoring schedule: 2-day occlusion and reading on Day 3.
- Removal of test substance: no data
- Other: no data


EXAMINATIONS:
- Grading/Scoring system: no data
- Statistical analysis: no data
- Other: no data

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms appeared with Ethylvanillin.


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 1
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0


RESULT OF CASE REPORT: negative


OTHER RESULTS: positive reaction with Coumarin on Day 2, which is one of constituent of the perfume.

Applicant's summary and conclusion

Conclusions:
not sensitizing
Executive summary:

In the study of Mutterer (1999) one woman, 44 years old, with no previous problems developed an axillary rash using a perfumed deodorant. At the same time she started to use an eau de toilette of the same brand and developed a rash on the neck and on the trunk. The rash disappeared on treatment with topical corticosteroids for a few days. The patient started applying both products again and developed a generalized eczema.

Ethylvanillin tested was issued from an eau de toilette that was chemically fractionned by flash column chromatography on silica gel. The test substance was tested at 1% in ethanol by the patient in a ROAT (Repeated Open Application Test), using 1 drop (25 µl) of the ethanolic solution applied openly 3 times a day to a 4 cm² use test site, elbow flexure right. 10 consecutive eczema patients that were patched negative to the substance served as controls and did a 3-day ROAT with the substance in the manner similar to the patient.

No sensitisation effect was reported with ethylvanillin.