Registration Dossier
Registration Dossier
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EC number: 249-220-0 | CAS number: 28783-41-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro DNA damage and/or repair study
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study start: January 1994 / Report date: Augsut 1994
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: A GLP study but not according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Evaluate DNA repair synthesis consecutive to a lesion possibly induced by the compound by measuring the incorporation of tritiated thymidine in rat hepatocytes in primary cultures.
- GLP compliance:
- yes
- Type of assay:
- DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro
Test material
- Reference substance name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride
- IUPAC Name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride
- Reference substance name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridinium chloride
- EC Number:
- 249-220-0
- EC Name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridinium chloride
- Cas Number:
- 28783-41-7
- Molecular formula:
- C7H9NS.ClH
- IUPAC Name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-ium chloride
- Details on test material:
- Batch 3SNL501
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- hepatocytes: Male (DNA019) and female (DNA019A) Fischer rat hepatocytes
- Test concentrations with justification for top dose:
- 5 -10 - 25 - 50 - 100 - 250 - 500 - 1000 - 2500 - 5000 µg/ml (DNA019)
10 - 25 - 50 - 100 - 250 - 500 µg/ml (DNA019A)
Reading of slides: 25 -50 - 100 - 250 - 500 µg/ml (DNA019)
50 - 100 - 250- 500 µg/ml (DNA019A) - Vehicle / solvent:
- Solvent: Distilled water (1%)
Controls
- Untreated negative controls:
- yes
- Remarks:
- Untreated cells/Solvent (Dimethyl sulfoxide)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Distilled water (1%)
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminofluorene (0.1 and 0.5 µM)
- Details on test system and experimental conditions:
- No. of cultures/concentration: 3
No. of cells scored/concentration: At least 100 (on 2 slides at least)
Number of studies: 2 (DNA019 and DNA019A)
Results and discussion
Test results
- Species / strain:
- hepatocytes: Male (DNA019) and female (DNA019A) Fischer rat hepatocytes in primary culture
- Metabolic activation:
- not specified
- Genotoxicity:
- positive
- Remarks:
- Marginal genotoxicity response at 500 µg/ml: mean net grain count = +1.1 (DNA019) and +2.3 (DNA0.19A) - % cells in repair: 18% (DNA019) and 32 % (DNA019A)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxic effect from 1000 µg/ml upwards
- Positive controls validity:
- other: Positive control induced incorporation of many nuclear grains at both concentration indicating an intense DNA repair synthesis
Applicant's summary and conclusion
- Conclusions:
- PCR 0665 induced a marginal genotoxicity response in the in vitro DNA repair assay at 500 µg/ml only. No genotoxic effects at lower concentrations.
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