Registration Dossier
Registration Dossier
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EC number: 203-608-6 | CAS number: 108-70-3
Genetic toxicity: in vitro
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:
- OCT 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
- Report date:
- 2022
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-trichlorobenzene
- EC Number:
- 203-608-6
- EC Name:
- 1,3,5-trichlorobenzene
- Cas Number:
- 108-70-3
- Molecular formula:
- C6H3Cl3
- IUPAC Name:
- 1,3,5-trichlorobenzene
- Test material form:
- solid
- Details on test material:
- • Sponsor’s identification: TCB (1,3,5-trichlorobenzène)
• Batch No.: 171882
• Category: Chemical Substance
• Date received: 17 September 2021
• EINECS No.: 203-608-6
• Container: plastic flask (n=1)
• CAS No : 108-70-3
• Quantity: 101.00 g (container + content + label)
• Form: solid
• Homogeneity: yes • Colour: white
• Production date: not provided
• Expiry date: February 2024
• Storage: room temperature
• Purity: 99,85 %
• Stability: stable under storage conditions
• Composition : 99.85 % 1,3,5-trichlorobenzène
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with
- Metabolic activation system:
- (S9-mix 10% (v/v))
Results and discussion
Test resultsopen allclose all
- 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
- 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
- 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
- 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
- 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 TCB (1,3,5 -
trichlorobenzène) do 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. - Executive summary:
Solutions obtained from TCB (1,3,5 - trichlorobenzène) have been tested for their capacity to induce reverse mutation in four Salmonella typhimurium strains and one Escherichia coli WP2(uvr A ̄)(pKM101) strain. This study was performed in the absence and presence of metabolic activation. Two independent assays were carried out
For assay n° 1, various concentrations were put in contact with the strains in the absence and presence of a metabolic activation system (S9-mix 10% (v/v)).
For assay n° 2, various concentrations were put in contact with the strains in the absence of metabolic activation and with pre-incubation in the presence of metabolic activation system (S9-mix 10% (v/v)).
For the two assays, negative and positive controls were carried out in parallel. Positive controls induced a significant increase in the number of revertant colonies compared to negative controls. There is no difference between the number of spontaneous reversions, the number of reversions obtained in the positive controls (without and with metabolic activation), and the mean of corresponding experimental “historical” values obtained in the laboratory (Table 11). There is no evidence of any increase in the number of revertant colonies in the presence of the various concentrations of the test item (500, 150, 50, 15 and 5 μg/plate), without and with metabolic activation in Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and in Escherichia coli WP2(uvrA) (pKM 101).
These results validate the two tests.
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