Registration Dossier

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out : Acid Green 111

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : AMES with positive result
- Available non-GLP studies : not available
- Historical human data : no
- (Q)SAR : alerts found QSAR Toolbox 4.1:
DNA binding by OASIS : non covalent interaction
Carcinogenicity(genotox and nongetox) alerts by ISS: aromatic diazo (genotox), structural alert for genotoxic carcinogenicity
in vitro mutagenicity (Ames test) alerts by ISS: aromatic diazo
in vivo mutagenicity (micronucleus) alerts by ISS: aromatic diazo and H-acceptor-path3-H-acceptor
Oncologic primary classification: aromatic amine type compounds, arylazo type compounds and phenol type compounds
- In vitro methods : no conclusive information can be retrieved by available in vitro tests (see attached document)
- Weight of evidence : no other data is available and a weight of evidence is not applicable.
- Grouping and read-across : no read across data available
- Substance-tailored exposure driven testing: significant exposure may not be excluded
- Other reasons: see attached document

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- See attached document

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- See attached document

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion