1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C12-14(even numbered) 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

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

3-Dimethylaminopropylamine: a key substance in contact allergy to cocamidopropylbetaine?

Author:

Angelini G et al

Year:

1995

Bibliographic source:

Contact Dermatitis 32, 96-99

Materials and methods

Type of sensitisation studied:

skin

Study type:

other: study with patients

Principles of method if other than guideline:

Patch test on patients with dermatitis

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Test material form:

solid - liquid: aqueous solution

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

Study 1:
- Number of subjects exposed: 1200
- Time frame of study: 1994
- Sex: no data
- Average age/range of age: no data


Study 2:
- Number of subjects exposed: 30
- Sex: no data
- Average age/range of age: no data

Clinical history:

Study 1
- History of allergy: dermatitis of various types

Study 2
- History of allergy: positive reaction after patch test with Coco AAPB in study 1

Route of administration:

dermal

Details on study design:

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

Results and discussion

Results of examinations:

In study 1, 3.8 % (46/1200) of the patients showed allergic reactions and 1.25 % (15/1200) showed irritant reactions to Coco AAPB.

In study 2, 3/30 and 16/30 showed positive reactions to purer grade Coco AAPB (0.5 % and 1% aq.), compared to 30/30 positive reactions to Coco AAPB containing 3-dimethylaminopropylamine (DMPA) as impurity and 30/30 positive reactions to 3-dimethylaminopropylamine (DMPA) 1 % aq. The results suggest that DMPA is responsible for Coco AAPB allergy.

Any other information on results incl. tables

Study 1:

46/1200 patients showed positive allergic reactions to CAPB (3.8%)

15/1200 patients showed irritant reactions (slight erythema only) to CAPB (1.25%)

Study 2:

Substances with positive reactions tested:

- CAPB (30 % a.i.): 1 % aq. 30/30 (100 %)

- 3 -dimethylaminopropylamine 1 % aq. 30/30 (100 %)

- cocamidoamine 0.05 % aq. 0/30

- monochloracetic acid 0.1 % aq. 0/30

- CAPB purer grade (30 % a.i.) 1 % aq. 16/30 (53.3 %)

- Tego 103 G 1 % aq. 0/30

Remark: in the patients with irritant reactions, patch tests with all the above substances were negative (no detailed data given). No allergic or irritant reactions to DMPA were obtained in 50 healthy controls.

Applicant's summary and conclusion

Conclusions:

3/30 and 16/30 showed positive reactions to purer grade Coco AAPB (0.5 % and 1% aq.), compared to 30/30 positive reactions to
Coco AAPB, commercial grade, containing 3-dimethylaminopropylamine (DMPA) as impurity and 30/30 positive reactions to
3-dimethylaminopropylamine (DMPA) 1 % aq.. The results suggest that DMPA is responsible for Coco AAPB allergy.

Executive summary:

In a dermal sensitization study with Coco AAPB (30 % a.i.) in water, 1200 patients with dermatitis of various types (study 1), and 30 patients out of study 1 with positive reactions to Coco AAPB (study 2) were tested using the patch test method. Coco AAPB was tested in commercial grade and purer grade, 3-dimethylaminopropylamine (DMPA, 1 % aq.) was also tested.

In study 1, 3.8 % (46/1200) of the patients showed allergic reactions and 1.25 % (15/1200) showed irritant reactions to Coco AAPB. Whereas, all patients in study 2 showed positive reactions to Coco AAPB with high grade of impurities and DMPA. The positive reactions to Coco AAPB purer grades were 10 and 53 %, respectively. The authors suggested that DMPA present as impurity in the commercial Coco AAPB is responsible for Coco AAPB allergy.