Registration Dossier
Registration Dossier
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EC number: 247-640-9 | CAS number: 26381-41-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- calculation (if not (Q)SAR)
- Remarks:
- Migrated phrase: estimated by calculation
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from modelling database developed by the National Food Institute, Technical University of Denmark.
Data source
Reference
- Reference Type:
- other: Authoritative data base
- Title:
- Danish QSAR study for CAS No.:
- Author:
- Danish (Q)SAR Database
- Year:
- 2 016
- Bibliographic source:
- Database developed by National Food Institute, Technical University of Denmark, with support from the Danish Environmental Protection Agency, the Nordic Council of Ministers and the European Chemicals Agency.
Materials and methods
- Principles of method if other than guideline:
- The predicton is done using Danish (Q)SAR Database
- GLP compliance:
- no
- Type of study:
- other: Allergic contact dermatitis (ACD) in guinea pig and human
Test material
- Reference substance name:
- [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- EC Number:
- 247-640-9
- EC Name:
- [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride
- Cas Number:
- 26381-41-9
- Molecular formula:
- C19H21N4O.Cl
- IUPAC Name:
- 8-[(4-aminophenyl)diazenyl]-7-hydroxy-N,N,N-trimethylnaphthalen-2-aminium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride- Molecular formula (if other than submission substance): C19-H21-N4-O.Cl - Molecular weight (if other than submission substance): 356.855- Smiles notation (if other than submission substance): c1(\N=N\c2ccc(cc2)N)c2cc([N+](C)(C)C)ccc2ccc1O.[ClH-]- Substance type: Organic - Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: guinea pig and human
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: no data
- Vehicle:
- no data
Challenge
- Route:
- other: no data
- Vehicle:
- no data
Results and discussion
In vivo (non-LLNA)
Results
- Group:
- test chemical
- Clinical observations:
- Allergic Contact Dermatitis in Guinea Pig and Human give positive result
- Remarks on result:
- other: Group: test group. Clinical observations: Allergic Contact Dermatitis in Guinea Pig and Human give positive result.
Any other information on results incl. tables
Allergic Contact Dermatitis in Guinea Pig and Human give positive result
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be positive on guinea pig and human. Thus it can be concluded that the substance [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride has positive skin sensitization effects and based on the CLP criteria for classification it can be classified as skin sensitizer.
- Executive summary:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be positive on guinea pig and human. Thus it can be concluded that the substance[8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloridehas positive skin sensitization effects and based on the CLP criteria for classification it can be classified as skin sensitizer.
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