Registration Dossier
Registration Dossier
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EC number: 207-529-8 | CAS number: 479-27-6
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- In vivo alkaline single-cell gel electrophoresis assay for DNA strand breaks (comet assay)
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
1,8-naphthylenediamine
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION :
- Available GLP studies - none
- Available non-GLP studies - none
- Historical human/control data - none
- (Q)SAR - QSAR models were developed to classify a data set of aromatic and secondary amine compounds as genotoxic or nongenotoxic based on information calculated solely from chemical structure. Genotoxic endpoints of each compound were determined using the SOS Chromotest in both the presence and absence of an S9 rat liver homogenate. 1,8-naphthylenediamine was positive in the SOS Chromotest with and without metabolic activation and predicted as positive in binary quantitative structure-activity relationship (QSAR) models. Publication: Predicting the genotoxicity of secondary and aromatic amines using data subsetting to generate a model ensemble. Mattioni BE, Kauffman GW, Jurs PC ,J Chem Inf Comput Sci 43, 949-963 (2003)
- In vitro methods - positive in Ames test (OECD 471), negative in cell gene mutation (OECD 490) and equivocal in human lymphocytes (OECD 487)
- Weight of evidence - a positive result and an equivocal result from the in vitro assays means that appropriate in vivo mutagenicity studies shall be considered
- Grouping and read-across - nothing suitable found
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- GLP compliance:
- yes
- Type of assay:
- mammalian comet assay
Test material
- Reference substance name:
- 1,8-naphthylenediamine
- EC Number:
- 207-529-8
- EC Name:
- 1,8-naphthylenediamine
- Cas Number:
- 479-27-6
- Molecular formula:
- C10H10N2
- IUPAC Name:
- naphthalene-1,8-diamine
Constituent 1
Results and discussion
Applicant's summary and conclusion
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.
