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Registration Dossier
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EC number: 220-115-1 | CAS number: 2631-68-7
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- BACTERIAL REVERSE MUTATION TEST: Determination of mutagenic activity in mutated «Salmonella typhimurium his-» and «Escherichia coli» (OECD n°471)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,3,5-trichloro-2,6-dinitrobenzene
- Cas Number:
- 6284-83-9
- IUPAC Name:
- 1,3,5-trichloro-2,6-dinitrobenzene
- Reference substance name:
- 1,3,5-trichloro-2,4-dinitrobenzene
- EC Number:
- 228-510-0
- EC Name:
- 1,3,5-trichloro-2,4-dinitrobenzene
- Cas Number:
- 6284-83-9
- Molecular formula:
- C6HCl3N2O4
- IUPAC Name:
- 1,3,5-trichloro-2,4-dinitrobenzene
- Test material form:
- solid: particulate/powder
- Details on test material:
- • Date received: 17 September 2021
• CAS No.: 6284-83-9
• EINECS No.: 228-510-0
• Container: plastic flask (n=1)
• Category: Chemical Substance
• Quantity: 111.70 g (container + content + label)
• Storage: room temperature
• Homogeneity: yes
• Form: solid (powder)
• Stability: not specified
• Colour: yellowish
• Production date: not specified
• Expiry date: February 2024
• Composition: 1,3,5-trichloro-2,6-dinitrobenzene • Purity: 99.24%
It was identified under the code number: PH-21/0912.
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix 10% (v/v)
- Vehicle / solvent:
- • Negative controls :
o absolute negative control containing no test item corresponding to the spontaneous
reversion rate,
o solvent used to solubilize positive controls : Acetone, DMSO, NaCl 0.15 M
• Vehicle used to solubilize test item : DMSO
• Positive control
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other:
- Details on test system and experimental conditions:
- The assay is performed using five concentrations of the test item both in the absence and
presence of metabolic activation by a microsomal fraction of Rat liver. After a suitable period of
incubation, revertant colonies are counted and compared to the number of spontaneous
revertants. - Evaluation criteria:
- The following validity criteria were checked to validate each experiment:
• the bacteriostatic activity of the highest concentration tested shall be equal to or less than 75
%,
• the spontaneous reversion rate of the absolute negative control shall comply with the
historical values of the laboratory,
• In presence of the solvent the spontaneous reversion rate shall comply with the historical
values of the absolute negative control of the laboratory.
• the mean number of revertant colonies obtained for each strain and the corresponding
positive control, with and/or without metabolic activation shall comply with the historical
values of the laboratory.
• Negative and positive values should not show significant difference with the historical
values of the laboratory (± 2 standard deviations)
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Results for mutagenic activity are presented in the following tables:
o 6.1 to 6.4 for TA 1535
o 7.1 to 7.4 for TA 1537
o 8.1 to 8.4 for TA 98
o 9.1 to 9.4 for TA 100
o 10.1 to 10.4 for Escherichia coli.
Applicant's summary and conclusion
- Conclusions:
- In the assay conditions, solutions prepared from the test item DNTCB does not induce any mutagenic change in Salmonella typhimurium
TA 1535, TA 1537, TA 98, TA 100 strains and Escherichia coli WP2(uvr A ̄)(pKM101)
strain without, or with metabolic activation, according to the OECD Guideline n° 471.
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