Registration Dossier
Registration Dossier
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EC number: 204-620-4 | CAS number: 123-34-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The potential mutagenic activity has been assessed using the Bacterial Reverse Mutation Assay (Ames test) according to OECD 471 and in compliance with GLP. The test item had mutagenic activity in Salmonella typhimurium TA1535 bacterial strains without metabolic activation. No mutagenic activity was observed in Salmonella typhimurium TA98, TA100, TA1537 and Escherichia coli WP2 uvrA bacterial strains with and without metabolic activation and Salmonella typhimurium TA1535 with metabolic activation under the test conditions used in this study.
The in vitro micronucleus test is being undertaken as additional data to assess the Ames test result. Due to the availability of laboratory space, the study is schedule for completion after the phase-in deadline. Consequently, to allow for registration of the substance and member registration by co-registrants, this registration is being submitted with the data pending. The registrant will conduct the spontaneous update to to submit details of the data as soon as these become available, anticipated in Q3 or Q4 2018
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 October - 12 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Plate Incorporation method
- Deviations:
- yes
- Remarks:
- During the Confirmatory Mutation Test the incubation time was 21 minutes instead of 20 minutes in one case
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- activated rat liver S9
- Test concentrations with justification for top dose:
- 5000, 1581, 500, 158.1, 50 and 15.81 μg/plate
- Vehicle / solvent:
- Distilled water
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylene-diamine
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- The test item had mutagenic activity in Salmonella typhimurium TA1535 bacterial strains without metabolic activation. No mutagenic activity was observed in Salmonella typhimurium TA98, TA100, TA1537 and Escherichia coli WP2 uvrA bacterial strains with and without metabolic activation and Salmonella typhimurium TA1535 with metabolic activation under the test conditions used in this study.
- Executive summary:
The potential mutagenic activity has been assessed using the Bacterial Reverse Mutation Assay (Ames test) according to OECD 471 and in compliance with GLP. The test item had mutagenic activity in Salmonella typhimurium TA1535 bacterial strains without metabolic activation. No mutagenic activity was observed in Salmonella typhimurium TA98, TA100, TA1537 and Escherichia coli WP2 uvrA bacterial strains with and without metabolic activation and Salmonella typhimurium TA1535 with metabolic activation under the test conditions used in this study.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- The study is currently ongoing. This submission allows co-registrants to register for the deadline and the lead dossier will be spontaneously updated as soon as the result is available
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not yet reported
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell micronucleus test
- Target gene:
- L5178Y cells
- Vehicle / solvent:
- No information
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- other: result not yet available
- Cytotoxicity / choice of top concentrations:
- other: not yet available
- Vehicle controls validity:
- other: not yet available
- Untreated negative controls validity:
- other: not yet available
- Positive controls validity:
- other: not yet available
- Conclusions:
- The in vitro micronucleus test is being undertaken as additional data to assess the Ames test result. Due to the availability of laboratory soace, the study is schedule for completion after the phase-in deadline. Consequently, to allow for registration of the substance and member registration by co-registrants, this registration is being submitted with the data pending. The registrant will conduct the spontaneous update to to submit details of the data as soon as these become available, anticipated in Q3 or Q4 2018
- Executive summary:
The in vitro micronucleus test is being undertaken as additional data to assess the Ames test result. Due to the availability of laboratory space, the study is schedule for completion after the phase-in deadline. Consequently, to allow for registration of the substance and member registration by co-registrants, this registration is being submitted with the data pending. The registrant will conduct the spontaneous update to to submit details of the data as soon as these become available, anticipated in Q3 or Q4 2018
Referenceopen allclose all
Based on the results of the Preliminary Concentration Range Finding Test, the test item concentrations were in the Initial Mutation Test (plate incorporation) with and without metabolic activation in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA strains 5000, 1581, 500, 158.1, 50 and 15.81 μg/plate. In the Confirmatory Mutation Test (pre-incubation) the examined test item concentrations were with and without metabolic activation in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA strains 5000, 1581, 500, 158.1, 50, 15.81 and 5 μg/plate. In the Complementary Initial Mutation Test (plate incorporation) the examined concentrations were in Salmonella typhimurium TA1535 strain without metabolic activation 5000, 3750, 2500, 1250, 625 and 312.5 μg/plate. In the case of Salmonella typhimurium TA1535 strain without metabolic activation, in the Initial Mutation Test a slight positive was observed, in the Complementary Initial Mutation Test a clear, reproducible positive effect was obtained using the plate incorporation method.
Precipitate of the test item was not detected in the Preliminary Concentration Range Finding Test and in the main tests.
No inhibitory, cytotoxic effect of the test item was observed in the preliminary experiment and in the main tests.
The mean values of revertant colonies of the solvent control plates were within the historical control range, the reference mutagens showed the expected increase in the number of revertant colonies, the viability of the bacterial cells was checked by a plating experiment in each test. At least five analysable concentrations were presented in all strains of the main tests.
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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