1-dodecylpyridinium chloride

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1987

Report date:

1987

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:

Case report. Patch test with the European standard series (ICDRG) and lauryl pyridinium chloride 0.1% aqueous solution, amongst other substances (ingredients of a hair conditioner).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-dodecylpyridinium chloride

EC Number:

203-232-2

EC Name:

1-dodecylpyridinium chloride

Cas Number:

104-74-5

Molecular formula:

C17H30N.Cl

IUPAC Name:

1-dodecylpyridin-1-ium chloride

Test material form:

solid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 1
- Sex: male
- Age: 28

Clinical history:

- History of allergy or casuistics for study subject or populations:
- Symptoms: recurrent itchy dermatitis on the left side of the chest and adjacent area of the arm.
- Exposure history: the patient had noted that the eruption alsways developed after his wife had used a hair conditioner and rested hear head in the area when sleeping.

Controls:

23 healthy patients

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test). No further details.

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: recurrent itchy dermatitis, that disappeared after exposure was discontinued.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: the test subject and 1/23 control patients
- Number of subjects with negative reactions: 16/23 control patients
- Number of subjects with equivocal reactions: 6/23 control patients

RESULT OF CASE REPORT: In the tes subject, a positive reaction was found to lauryl pyridinium chloride 0.1% aq. (48h +, 72h ++), but not to 0.01% aq. Of 23 controls tested with lauryl pyridinium chloride 0.1% aq., 16 were negative, 6 had an equivocal reaction, and 1 had a positive reaction. Control tests indicated a delayed time course of irritation. The strength and appearance of the patch test reaction compared to the controls, and the patient's clinical features favoured an allergic mechanism.

Applicant's summary and conclusion

Conclusions:

Based on the available data, the test item may cause allergic contact dermatitis.

Executive summary:

A 28-year-old male presented recurrent itchy dermatitis on the left side of the chest and adjacent area of the arm, where his wife usually rested her head when sleeping. The patient had noted that the eruption always developed after his wife had used a hair conditioner. The patient was subjected to patch tests with the European standard series (ICDRG), the hair conditioner, and later, its ingredients, separately. A positive reaction was found to lauryl pyridinium chloride 0.1% aq. (48h +, 72h ++), but not to 0.01% aq. Of 23 controls tested with lauryl pyridinium chloride 0.1% aq., 16 were negative, 6 had an equivocal reaction, and 1 had a positive reaction. Control tests indicated a delayed time course of irritation. The strength and appearance of the patch test reaction compared to the controls, and the patient's clinical features favoured an allergic mechanism. Based on the available data, the test item may cause allergic contact dermatitis.