Registration Dossier
Registration Dossier
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EC number: 221-717-7 | CAS number: 3209-22-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The mutagenic potential of 2,3 -Dichloronitrobenzene was evaluated in several Ames tests (NTP 1979 and 1981). The test substance induced a weak positive response in Salmonella typhimurium tester strain TA100 in presence of metabolic activation tests (NTP 1979 and 1981). A further ames test was negative (Shimizu 1983).
In addition, the test substance 2,3-Dichloronitrobenzene was evaluated in 2 chromosome aberration test. A significant increase in cells with aberrations were noted in presence of metabolic activation (NTP 1984). Polyploidy was also induced after 48 hours continuous treatment with 1,2 -Dichloro-3-nitrobenzene (Ministry of Health and Welfare, Japan).
The test substance 2,3-Dichloronitrobenzene was also evaluated in a sister chromatid exchanges test (NTP 1984). A significant increase in cells with sister chromatid exchanges was observed with and without metabolic activation (NTP 1984).
Link to relevant study records
- Endpoint:
- in vitro DNA damage and/or repair study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 479 (Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells)
- GLP compliance:
- not specified
- Type of assay:
- sister chromatid exchange assay in mammalian cells
- Target gene:
- sister chromatid exchanges
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat liver S9)
- Test concentrations with justification for top dose:
- -S9: 0, 125.8, 150, 200, 250 µg/ml
+S9: 0, 100, 119.3, 140.9, 150.9 µg/ml
+S9 2nd trial: 0, 160, 170, 200 µg/ml - Vehicle / solvent:
- dimethyl sulfoxide
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9: Mitomycin C; +S9: Cyclophosphamide
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: Chinese hamster Ovary (CHO)
- Conclusions:
- Interpretation of results: positive
The test substance 2,3-Dichloronitrobenzene induced a significant increase in cells with sister chromatid exchanges with and without metabolic activation. - Executive summary:
The test substance 2,3-Dichloronitrobenzene was evaluated in a sister chromatid exchanges test (NTP 1984). A significant increase in cells with sister chromatid exchanges was observed with and without metabolic activation.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- number of metaphases examined not in line with current guideline
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- chromosome aberrations
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (rat liver S9)
- Test concentrations with justification for top dose:
- -S9: 0, 125.8, 150, 200, 250 µg/ml
+S9: 0, 100, 119.3, 140.9, 150.9 µg/ml
+S9 2nd trial: 0, 160, 170, 200 µg/ml - Vehicle / solvent:
- dimethyl sulfoxide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: -S9: Mitomycin C; +S9: Cyclophosphamide
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- with metabolic activation
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: strain/cell type: Chinese hamster Ovary (CHO)
- Conclusions:
- The test substance 2,3-Dichloronitrobenzene induced a significant increase in cells with aberrations in presence of metabolic activation.
- Executive summary:
The test substance 2,3-Dichloronitrobenzene was evaluated in a chromosome aberration test (NTP 1984). A significant increase in cells with aberrations were noted in presence of metabolic activation.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- tester strains used not in line with current guideline
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Ames test: single-base mutations, frame-shift mutations
- Species / strain / cell type:
- S. typhimurium, other: tester strains: TA100, TA1535, TA1537, TA98
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix (S9 homogenate from induced male Sprague Dawley rat liver S) and from induced male Syrian hamster liver S9)
- Test concentrations with justification for top dose:
- 0, 33, 100, 1000, 333 and 10000 µg/plate
- Vehicle / solvent:
- dimethyl sulfoxide
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (TA 100, TA 1535), 2-nitrofluorene or 4-nitro-o-phenylenediamine (TA 98), 9-aminoacridine (TA1537); +S9: 2-aminoanthracene (all strains)
- Species / strain:
- S. typhimurium, other: tester strains: TA100, TA1535, TA1537, TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- tester strain TA100 (with metabolic activation)
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- 2,3-dichloronitrobenzene induced a weak positive response in the ames assay in presence of metabolic activation.
- Remarks on result:
- other: strain/cell type: S. typhimurium tester strains: TA100, TA1535, TA1537, TA98
- Conclusions:
- 2,3 -Dichloronitrobenzene induced a weak mutagenic response in bacteria.
- Executive summary:
The mutagenic potential of 2,3 -Dichloronitrobenzene was evaluated in the Ames test (NTP 1981). The test substance induced a weak positive response in Salmonella typhimurium tester strain TA100 in presence of metabolic activation.
Referenceopen allclose all
2,3-dichloronitrobenzene induced an increase in cells with sister chromatid exchanges with and without metabolic activation.
2,3 -dichloronitrobenzene induced an increase in cells with aberrations with metabolic activation.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
No valid in-vivo assay available.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The mutagenic potential of 1,2-dichloro-3-nitrobenzene (CAS 3209-22-1) was evaluated in several Ames tests (NTP 1979 and 1981). The test substance induced a weak positive response in Salmonella typhimurium tester strain TA100 in presence of metabolic activation tests (NTP 1979 and 1981). A further Ames test was negative (Shimizu 1983).
In addition, the test substance 1,2-dichloro-3-nitrobenzene was evaluated in 2 chromosome aberration test. A significant increase in cells with aberrations were noted in presence of metabolic activation (NTP 1984). Polyploidy was also induced after 48 hours continuous treatment with 1,2 -Dichloro-3-nitrobenzene (Ministry of Health and Welfare, Japan).
The test substance 1,2-dichloro-3-nitrobenzene was also evaluated in a sister chromatid exchanges test (NTP 1984). A significant increase in cells with sister chromatid exchanges was observed with and without metabolic activation (NTP 1984).
No valid in vivo mutagenicity assay is available.
Based on the available mutagenicity tests, 1,2-dichloro-3-nitrobenzene (CAS 3209-22-1) is classified as inconclusive (self classification according to CLP regulation).
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