Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Occupational contact allergy to cocamidopropyl betaine and its impurities
Author:
Suuronen K, Pesonen M, Aalto-Korte K.
Year:
2012
Bibliographic source:
Contact Dermatitis,olume66, Issue5 May 2012 Pages 286-292

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: patch test
Principles of method if other than guideline:
To describe patients with positive patch test reactions to cocamidopropyl betaine-related compounds in an occupational dermatology clinic
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not reported

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material : 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts- Molecular formula : C19H38N2O3- Molecular weight : 342.52 g/mol- Smiles notation : CCCCCCCCCCCC(=O)NCCCN{+}(C)(C)CC(=O)O{-}- Substance type : Organic - Physical state : Solid
Specific details on test material used for the study:
- Name of test material : 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts- Common Name: Cocamidopropyl betaine (CAPB)- Molecular formula: C19H38N2O3- Molecular weight: 342.52 g/mol- Smiles notation: CCCCCCCCCCCC(=O)NCCCN{+}(C)(C)CC(=O)O{-}- Substance type: Organic - Physical state: Solid

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Details on test animals and environmental conditions:
Source: Finnish Institute of Occupational Health (FIOH)

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1% in water
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1%
Adequacy of challenge:
not specified
No. of animals per dose:
1092 patients
Details on study design:
the dermal reactions were read two or three times: on D2/D3/D4 or D2/D3/D6 or D2/D5, depending on the day of application
Challenge controls:
no data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
1% in water
No. with + reactions:
2
Total no. in group:
1 092
Clinical observations:
+++/++ reactions were observed
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Patch test reactions to cocamidopropyl betaine (CAPB) and its impurities during 2002–2009 (1092 patients)

 test substance (provider, vehicle)

 Allergic

(++/+++/+++) reactions, n(%)

 irritant reactions

n(%)

 CAPB [Chemotechnique Diagnostics], water  2 (0.2)  166 (5)

cocamidopropyl betaine (CAPB)

Applicant's summary and conclusion

Interpretation of results:
other: sensitizing
Conclusions:
2 of the 1092 patients tested showed allergic reactions to CAPB. Patch test reactions to cocamidopropyl betaine were difficult to interpret, owing to extremely common irritant reactions.Based on this observation, Cocamidopropyl betaine can be considered to be a potentially weak skin sensitizer.
Executive summary:

The aim of the study was to describe patients with positive patch test reactions to cocamidopropyl betaine-related compounds in an occupational dermatology clinic between 2002 -2009. Cocamidopropyl betaine[CAPB] was tested 1% in distilled water.

1092 patients were patch tested with Finn Chambers® according to the recommendations of the International Contact Dermatitis Research Group. The dermal reactions were read two or three times: on D2/D3/D4 or D2/D3/D6 or D2/D5, depending on the day of application. The patch test reactions were rated +/++/+++. 2 of the 1092 patients tested showed allergic reactions to CAPB. Patch test reactions to cocamidopropyl betaine were difficult to interpret, owing to extremely common irritant reactions.

Based on this observation, Cocamidopropyl betaine can be considered to be a potentially weak skin sensitizer.