Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 263-058-8 | CAS number: 61789-40-0
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:
- 2 012
- 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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
