1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts

Sensitisation data (human)

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:

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

Data source

Reference

Reference Type:

publication

Title:

The role of 3-dimethylaminopropylamine and amidoamine in contact allergy to cocamidopropylbetaine.

Author:

Foti C et al

Year:

2003

Bibliographic source:

Contact Dermatitis 48, 194-198

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Human patch test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts

EC Number:

931-333-8

Cas Number:

147170-44-3

Molecular formula:

not applicable

IUPAC Name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated acyl) derivs., hydroxides, inner salts

Test material form:

solid - liquid: aqueous solution

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 10
- Sex: no data
- Age: no data
- Race: no data
- Demographic information: no data

Clinical history:

- History of allergy or casuistics for study subject or populations: Contact allergy to Coco AAPB which contains impurities

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive / semiocclusive /other:
- Description of patch: Al-Test (Imeco AB, Södertälje, Sweden) products, attached with Scanpor tape (Norgeplaster, Vennesla, Norway).
- Reading: 2, 4, 7 day
- Control patch with purified amidoamine (0.5 % aq.) performed in 20 healthy subjects

Beside Coco AAPB 1 % aq. the following substances were also tested:
DMAPA 1 % aq. (Chemotechnique Diagnostics)
Amidoamine: 0.5, 0.25, 1 % aq.. The amidoamine solution was purified by the authors. the residual concentration of DMAPA in purified amidoamine was monitored. The DMAPA detection limit was found to be 0.5 ppm.

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION (n=10)
- Number of subjects with positive reactions to Coco AAPB which contains impurities 1 % aq.: 10 (++)
- Number of subjects with positive reactions to purified Coco AAPB 1 % aq. (Chemotechnique): 0
- Number of subjects with positive reactions to DMAPA 1 % aq.: 10 (++)
- Number of subjects with positive reactions to pure amidoamine (0.5 % aq.): 10 (++)
- Number of subjects with positive reactions to pure amidoamine (0.25 % aq.): 7 (++), 3 (+)
- Number of subjects with positive reactions to pure amidoamine (0.1 % aq.): 4 (++)

Control patch with purified amidoamine (0.5 % aq.) performed in 20 healthy subjects gave negative results.

Applicant's summary and conclusion

Conclusions:

It is considered that simultaneous allergic reaction to 3-dimethylaminopropylamine (DMAPA) and amidoamine represents cross-reactivity and hypothesized that 3-dimethylaminopropylamine is in fact the true sensitizing substance. The observed cross-reactivity is due to the fact that amidoamine hydrolyzes in the skin to DMAPA. It is advised that testing of Coco AAPB is suspended, because - when thoroughly purified, it no longer has a sensitizing action.

Executive summary:

In a dermal sensitization study with Coco AAPB (1% aq., one manufacturer with high purity and another with lower purity), 3-Dimethylaminopropylamine (1 % aq.), and purified amidoamine (0.5, 0.25, 0.1 % aq.) 10 patients with a contact allergy to Coco AAPB (which contained impurities) were tested using the patch test method.

No patient was sensitized to high purity Coco AAPB whereas 10 of 10 patients were sensitized to Coco AAPB with a lower grade, 3-dimethylaminopropylamine (1 % aq.) and purified aminomine 0.5, 0.25 % aq.). The authors suggested that purified Coco AAPB has no sensitizing action. They concluded that 3-dimethylaminopropylamine was the true sensitizing substance whereas amidoamine, which may release 3-dimethylaminopropylamine in vivo by enzymatic hydrolysis, was implicated in the transepidermal penetration of this sensitizing agent.