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Toxicological information

Sensitisation data (human)

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Administrative data

sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
4 (not assignable)
Rationale for reliability incl. deficiencies:

Data source

Reference Type:
Phenoxyethanol-induced urticaria
Bohn, S. and Bircher, A. J.
Bibliographic source:
Allergy 56: 922-923

Materials and methods

Type of sensitisation studied:
Study type:
case report
Principles of method if other than guideline:
Skin prick test and open application test with phenoxyethanol in a woman with acute urticaria after ingestion of papaya salad and again after taking a shower was described.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Specific details on test material used for the study:
- Name of test material (as cited in study report): phenoxyethanol
- Analytical purity: no data


Type of population:
other: patient
Ethical approval:
not specified
1 female 24 years old
Clinical history:
Acute urticaria

She had never suffered from aquagenic or any other physical urticaria. She had no history of atopy or previous allergic reactions to food or drugs. She had been taking oral contraception with the same preparation for many years. She did not take any drugs.
2 additional persons served as control
Route of administration:
Details on study design:
Skin prick test (estimated 30 minutes) and open application test (30 minutes) with phenoxyethanol in a woman with acute urticaria after ingestion of papaya salad and again after taking a shower was described.
Open application test and skin prick test (with two controls) were performed with body lotion, 1.0 % Euxyl K 400 petrolatum and a dilution series of phenoxyethanol (1.0 - 10 %). Determination of specific IgE antibodies was also performed.

Results and discussion

Results of examinations:
Prick test with the body lotion gave +++ reaction (histamine ++). In an open application test the single ingredients of the body lotion for 30 minutes resulted in strong wheal reaction with pseudopods to phenoxyethanol (PE). Tests with all other ingredients were negative. The prick test with Euxyl K 400 1% petrolatum and with a dilution series of PE resulted in ++ reaction to Euxyl K 400 in a ++ reaction to Euxyl K 400 and in a + reaction to 1.0 % PE, * to 5.0 % PE, and ++ to 10 % PE. The same test in 2 control persons gave negative results.
The single components of the lotion (except PE) were negative also in the patch test. A serum sample from the patient was tested for IgE antibodies against PE with experimental prototype reagents. The test could not confirm the presence of IgE against PE. Total IgE were slightly elevated at 75.10 kU/I.An immediate reaction to PE with contact urticaria reaction to the body lotion was observed (1.0 % PE).
The strong +++ wheal reaction to the body lotion is not completely consistent with the results of the dilution series with PE. The reason for this difference might be the vehicle. The dilution series were performed in an aqueous solution, by which the percutaneous penetration and absorption might have been lowered.

Skin prick test with phenoxyethanol (10 %, 5.0 %, and 1.0 % in petrolatum) was positive in the patient, and negative in the two controls. IgE antibodies were negative. Total IgE was slightly elevated.

Applicant's summary and conclusion