Registration Dossier
Registration Dossier
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EC number: 274-668-9 | CAS number: 70546-25-7
Genetic toxicity: in vivo
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
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
Macrolex Fluoreszenzrot G (CAS 70546-25-7)
- Name of the substance for which the testing proposal will be used [if different from tested substance]
Not applicable
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies
No studies available
- Available non-GLP studies
No studies available
- Historical human data
No studies available
- (Q)SAR
A potential alert for “in vitro mutagenicity (Ames) by ISS” was identified by the OECD Toolbox QSAR assessment; “Aromatic mono- and dialkylamine” and “Coumarins and Fucocoumarins”. (OECD Toolbox; QSAR Toolbox 4.1.)
- In vitro methods
Macrolex Fluoreszenzrot G was tested in a recent bacterial reverse gene mutation assay (Ames Test according to OECD TG 471) and considered to be mutagenic in the presence of S9 under the conditions of this test. In another bacterial reverse mutation assay with limited documentation Macrolex Fluoreszenz Rot G was found to be not mutagenic either with or without exogenous metabolic activation at the dose levels investigated.
- Weight of evidence
No further data available for a Weight of Evidence evaluation.
- Grouping and read-across
No group or read across identified (OECD Toolbox; QSAR Toolbox 4.1.)
- Substance-tailored exposure driven testing [if applicable]
Not applicable
- Approaches in addition to above [if applicable]
Not applicable
- Other reasons [if applicable]
Not applicable
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:
According to Annex 7 colume 2 “further mutagenicity studies shall be considered in case of a potive result”. Another in vitro test is not appropriate because Annex 8 colume 2 reads: “Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII.”
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
OECD Guidelines for Testing of Chemicals No. 489 “In vivo Mammalian Alkaline Comet Assay” (Adopted 29 July 2016)
The study will be conducted in rats and exposure will be via oral gavage.
No target organ is identified because no repeated dose toxicity study is available and Macrolex Fluoreszenzrot G is not toxic in an acute oral toxicity study and not irritating to skin or eyes. Consequently, the organs defined by ECHA as default organs will be investigated: bone marrow, liver, glandular stomach and duodenum.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
Test material
- Reference substance name:
- 3-(benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-1-benzopyran-4-carbonitrile
- EC Number:
- 274-668-9
- EC Name:
- 3-(benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-1-benzopyran-4-carbonitrile
- Cas Number:
- 70546-25-7
- Molecular formula:
- C21H17N3O2S
- IUPAC Name:
- 3-(1,3-benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-chromene-4-carbonitrile
- Test material form:
- solid
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.
