Propylenediamine

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: human patch test on six patients

Adequacy of study:

other information

Study period:

not specified

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

unsuitable test system

Remarks:

patients acutely suffering from dermatitis or eczema, without information of clinical history, were tested

Data source

Reference

Reference Type:

publication

Title:

Activation and cross-reactivity pattern of a new allergen in adhesive plaster

Author:

O. Bergendorff, C. Hansson

Year:

1999

Bibliographic source:

Contact Dermatitis, 2000, 42, 11–17

Materials and methods

Type of sensitisation studied:

skin

Principles of method if other than guideline:

- Principle of test: patch test
- Short description of test conditions: exposure duration: 2 days
- Parameters analysed / observed: read out after 3 and 7 days; grading according to the International Contact Dermatitis Group scale

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propylenediamine

EC Number:

201-155-9

EC Name:

Propylenediamine

Cas Number:

78-90-0

Molecular formula:

C3H10N2

IUPAC Name:

propane-1,2-diamine

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source of test material: Lancaster, Lancashire, England
- Purity not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
no data available

FORM AS APPLIED IN THE TEST (if different from that of starting material) : in petrolatum (in pet.)

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 4
- Sex: not specified
- Age: not specified
- Race: not specified
- Demographic information: no information available

Clinical history:

- History of allergy or casuistics for study subject or populations: All patients were referred to the clinic, where the patch test was conducted, for hand eczema except for patient no. 1, who presented with a history of dermatitis after the use of an adhesive plaster, and patient no. 3, who had a facial dermatitis.
- Symptoms, onset and progress of the disease: no information given
- Exposure history: no information given
- Aggravating factors both in home and workplace: no information given
- Family history: no information given
- Any other allergic or airway disorders: no information given
- Smoking history: no information given

Controls:

yes, present, but without further details.

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: Finn ChambersA (Epitest Ltd Oy, Finland) mounted on ScanporA (Norgesplaster A/S, Norway)
- Vehicle / solvent: petrolatum
- Concentrations: 1 %
- Volume applied: not specified
- Testing/scoring schedule: The patches were removed after 2 days and read after 3 and 7 days.
- Removal of test substance: not specified

EXAMINATIONS
- Grading/Scoring system: Gradings were made according to the International Contact Dermatitis Group scale.
- Statistical analysis: no

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: not specified

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 4/4
- Number of subjects with negative reactions: 0/4
- Number of subjects with equivocal reactions: 0/4
- Number of subjects with irritating reactions: not specified

Any other information on results incl. tables

"The patch test results show that all 6 patients with positive reactions to N,N-disalicylidene-1,2-diaminopropane and 1,2-diaminopropane cross-reacted with ethylenediamine but manifested no reaction to salicylaldehyde. 4 patients (nos. 1–4) were also tested with N,N-disalicylidene-1,2-ethylenediamine, to which they were positive. 1 of these patients (no. 4) manifested a weak reaction to N,N-disalicylidene-1,3-diaminopropane.

The results demonstrate reaction to an imine to be accompanied by reaction to its corresponding amine. We also found that all patients reacting to ethylenediamine also reacted to both N,N-disalicylidene-1,2-diaminopropane and 1,2-diaminopropane. Finally, no patient in this study manifested reaction to salicylaldehyde."

Applicant's summary and conclusion

Conclusions:

Bergendorff and Hansson (2000) published a human patch test, which investigated the reaction of six patients to the reactive, lipophilic imine N,N-disalicylidene-1,2 -diaminopropane. Further, the authors tested cross-reactivity with the corresponding amine 1,2 -diaminopropane and other structural analogues. Patch tests with N,N-disalicylidene-1,2-diaminopropane, 1% 1,2 -diaminopropane or structural analogues in petrolatum were applied to the skin of four (out of six) patients using Finn Chambers mounted on Scanpor. The patches were removed after 2 days and read after 3 and 7 days. Gradings were made according to the International Contact Dermatitis Group scale. All tested patients showed a positive result for N,N-disalicylidene-1,2-diaminopropane and cross-reacted with 1,2-diaminopropane and ethylenediamine but not with salicylaldehyde or 1,3-diaminopropane. However, all six patients were acutely suffering from hand eczema, dermatitis after the use of an adhesive plaster, or facial dermatitis. No information regarding clinical history, onset and progress of the disease, exposure history or aggravating factors was provided. Thus, the immune system of the patients were in a hypersensitive state and it is not clear which allergen induced the immunological memory. Hence, the study was not considered for assessment and reliability was set at 3.

Executive summary:

The skin sensitising potential of N,N-disalicylidene-1,2-diaminopropane and its hydrolysis product 1,2 -diaminopropane was investigated in a human patch test with six patients. Patch tests with 1% of 1,2 -diaminopropane in petrolatum were applied to the skin of four (out of six) patients using Finn Chambers mounted on Scanpor. All patients were suffering from hand eczema, dermatitis after the use of an adhesive plaster, or facial dermatitis. The patches were removed after 2 days and read after 3 and 7 days. Gradings were made according to the International Contact Dermatitis Group scale.

All patients showed a positive result for N,N-disalicylidene-1,2-diaminopropane and cross-reacted with 1,2-diaminopropane and ethylenediamine but not with salicylaldehyde or 1,3-diaminopropane.