1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Skin sensitisation

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:

To determine the skin sensitization potential of test chemical

Author:

Suuronen K et. al.

Year:

2012

Bibliographic source:

Contact Dermatitis, 2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: patch test

Principles of method if other than guideline:

To describe patients with positive patch test reactions to test chemical-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

Test material information

Constituent 1

Reference substance name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

EC Number:

263-058-8

EC Name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Cas Number:

61789-40-0

Molecular formula:

C19H38N2O3

IUPAC Name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

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

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 chemical

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(%)
Test chemical [Chemotechnique Diagnostics], water	2 (0.2)	166 (5)

Applicant's summary and conclusion

Interpretation of results:

other: sensitizing

Conclusions:

2 of the 1092 patients tested showed allergic reactions to test chemical. Patch test reactions to test chemical were difficult to interpret, owing to extremely common irritant reactions.Based on this observation, the test chemical 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 test chemical-related compounds in an occupational dermatology clinic between 2002 -2009. The test chemical 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 test chemical. Patch test reactions to test chemical were difficult to interpret, owing to extremely common irritant reactions. Based on this observation, the test chemical can be considered to be a potentially weak skin sensitizer.