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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD Guidelines for the Testing of Chemicals, Part 471, adopted 21. Jul. 1997
“Bacterial Reverse Mutation Test“ - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP-Conformity All procedures will be according to the principles of GLP (Chemikaliengesetz §19a and §19b and annexes 1 and 2 from 28. Aug. 2013, published in Federal Law Gazette, Germany (BGBl) No. 55/2013 as of 06. Sep. 2013, and further revisions).
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: The test material is representative of the registered substance
- Expiration date of the lot/batch: not relevant
- Purity test date: not relevant
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: soluble
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any): none
Method
- Target gene:
- Name Category Effect
hisD6610 frame shift histidine deficiency
hisD3052 frame shift histidine deficiency
hisG46 base pair substitution histidine deficiency
hisG428 base pair substitution histidine deficiency
uvrB deletion UV sensitivity, biotin deficiency
rfa deletion lipopolysaccharide side chain deficiency
pKM101 plasmid ampicillin resistance
pAQ1 plasmid tetracycline resistance
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA97A
- Details on mammalian cell type (if applicable):
- hisD6610 frame shift histidine deficiency
uvrB deletion UV sensitivity, biotin deficiency
rfa deletion lipopolysaccharide side chain deficiency
pKM101 plasmid ampicillin resistance
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- hisD3052 frame shift histidine deficiency
uvrB deletion UV sensitivity, biotin deficiency
rfa deletion lipopolysaccharide side chain deficiency
pKM101 plasmid ampicillin resistance
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- hisG46 base pair substitution histidine deficiency
uvrB deletion UV sensitivity, biotin deficiency
rfa deletion lipopolysaccharide side chain deficiency
pKM101 plasmid ampicillin resistance
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- hisG428 base pair substitution histidine deficiency
rfa deletion lipopolysaccharide side chain deficiency
pKM101 plasmid ampicillin resistance
pAQ1 plasmid tetracycline resistance
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- hisG46 base pair substitution histidine deficiency
uvrB deletion UV sensitivity, biotin deficiency
rfa deletion lipopolysaccharide side chain deficiency
- Metabolic activation:
- with and without
- Metabolic activation system:
- Specification S9: produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intra-peritoneally.
- Test concentrations with justification for top dose:
- 5 µL/plate, 1.5 µL/plate, 0.5 µL/plate, 0.15 µL/plate and 0.05 µL/plate
- Vehicle / solvent:
- In a non-GLP pre-test, the solubility of the test item was determined in demineralised wa-ter, acetone and dimethyl sulfoxide (DMSO). The test item is soluble in a concentration of 50 mL/L in DMSO.
Based on these results, DMSO will be used as solvent in the experiments.
Therefore, a test item solution containing 50 ± 5 mL/L in DMSO will be prepared in the initial experiment.
Controls
- Untreated negative controls:
- other: determination of spntaneous revertants
- Remarks:
- spontaneous revertants of the negative control are compared to the historical data of the laboratory
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide (DMSO) for test item and the positive controls nitrophenylendiamine, benzo-a-pyrene and 2-amino-anthracene Demineralised water for the positive control sodium azide.
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: Nitrophenylendiamine
- Details on test system and experimental conditions:
- VALIDITY
Genotype
Each strain must fulfil the requirements concerning the presence (or absence) of specific mutations. The following genotype specifications of the test system were tested for each batch (procedure is laid down in corresponding SOP):
• histidine deficiency
• Ampicillin-/Tetracycline-resistance (pKM101 and pAQ1; for TA97a, TA98, TA100, TA102; control : TA1535)
• Sensitivity against crystal violet (deep rough/rfa, for TA 97a, TA98, TA100, TA102, TA1535)
• UV-sensitivity (uvrB, only TA102 may show growth)
Spontaneous Revertants
If the spontaneous revertants of the negative control were in the range of the historical data of the laboratory.
Positive Controls
Mutagenicity of all positive controls must be detected. The revertant numbers was compared with the history of revertants based on the tests performed in the test facility.
Titre Determination
The titre determination showed a density of at least 109 bacteria/mL. If the detected number is lower but the spontaneous revertants lie within the normal range, the test may be stated as valid.
Sterility Control
No growth of bacteria should be detected. - Rationale for test conditions:
- The study is implemented with the following guidelines:
• OECD Guidelines for the Testing of Chemicals, Part 471, adopted 21. Jul. 1997
“Bacterial Reverse Mutation Test“
• Commission Regulation (EC) No. 440/2008, EU-Method B.13/14 adopted 30. May 2008 “Mutagenicity –Reverse mutation test using bacteria”
Additional information was taken from:
• K. Mortelmans, Errol Zeiger: “The Ames Salmonella/microsome mutagenicity assay”, Mutation Research 455 (2000) 29-60, Elsevier Science B.V.
• D.M. Maron, B.N. Ames: “Revised methods for the Salmonella mutagenicity test”, Mutation Research 113 (1983) 173-215, Elsevier Biomedical Press
Corresponding SOP of LAUS GmbH
• SOP 118 008 03 edition 13, valid from 24. Jul. 2017
“Bestimmung des erbgutverändernden Potentials mit dem Bacterial-Reverse-Mutation-Test (Ames-Test)“ - Evaluation criteria:
- The mean values and standard deviations of each threefold determination are calculated as well as the increase factor of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls. Additionally, the absolute number of revertants (mean revertants minus mean spontaneous revertants) is given.
A substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
Tables and, if applicable, graphs of the values will be included in the final report. It will be stated, at which concentration (µL or nL/plate) mutagenicity could be observed. The lowest concentration which showed mutagenicity is decisive of the assessment of the test item.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Detailed results not available at the moment. Test item is cytotoxic
VALIDITY
Genotype
Each strain must fulfil the requirements concerning the presence (or absence) of specific mutations. The following genotype specifications of the test system will be tested for each batch (procedure is laid down in corresponding SOP):
• histidine deficiency
• Ampicillin-/Tetracycline-resistance (pKM101 and pAQ1; for TA97a, TA98, TA100, TA102; control : TA1535)
• Sensitivity against crystal violet (deep rough/rfa, for TA 97a, TA98, TA100, TA102, TA1535)
• UV-sensitivity (uvrB, only TA102 may show growth)
Spontaneous Revertants
If the spontaneous revertants of the negative control are not in the range of the historical data of the laboratory and the mutagenicity of the test item is not clear, the experiment will be repeated.
Positive Controls
Mutagenicity of all positive controls must be detected. The revertant numbers will be com-pared with the history of revertants based on the tests performed in the test facility. If no mutagenicity is detected, the experiment will be repeated with the respective strain.
Titre Determination
The titre determination should show a density of at least 109 bacteria/mL. If the detected number is lower but the spontaneous revertants lie within the normal range, the test may be stated as valid. This decision is responsibility of the study director.
Sterility Control
No growth of bacteria should be detected.
Applicant's summary and conclusion
- Conclusions:
- not mutagenic and not cytotoxic
- Executive summary:
In in vitro study according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) and EU B.13/14
the substance was tested with 5 strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102, TA1535), without and with S-9 mix Aroclor 1254 induced rat liver metabolic activation system, to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs.
In the Bacterial Reverse Mutation Test, the test item didn´t show any mutagenic potential.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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