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EC number: 700-345-3 | CAS number: 515851-08-8
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Directive 2000/32/EC, L1362000, Annex 4D,dated May 19, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N4-[3-(1H-imidazol-1-yl)propyl]-2-methylbenzene-1,4-diamine trihydrochloride
- EC Number:
- 700-345-3
- Cas Number:
- 515851-08-8
- Molecular formula:
- C13H21Cl3N4
- IUPAC Name:
- N4-[3-(1H-imidazol-1-yl)propyl]-2-methylbenzene-1,4-diamine trihydrochloride
- Reference substance name:
- [TN]Kn 172[/TN][SPEC][/SPEC][AM]99%[/AM
- IUPAC Name:
- [TN]Kn 172[/TN][SPEC][/SPEC][AM]99%[/AM
- Details on test material:
- Kn 172
Batch No.: Kn-Gi-8634/1
SAT 030768
Constituent 1
Constituent 2
Method
- Target gene:
- hisC3076 (frameshift): S. typhimurium TA1537
hisD3052/R-factor (frameshift): S. typhimurium TA98
hisG46 (base-pair substitutions): S. typhimurium TA1535
hisG46/R-factor (base-pair substitutions): S. typhimurium TA100
his G 428; rfa-; uvrB';R-factor(base-pair substitutions): S.typhimurium TA102
Species / strain
- Species / strain / cell type:
- other: TA 98, TA 100, TA 102, TA 1535, 1537
- Additional strain / cell type characteristics:
- other: each Salmonella strain, additional mutations: rfa-; uvrB';R-factor
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbitallß-Naphthoflavone induced rat liver S9 is used as the metabolic activation system. The S9 is prepared from 8 - 12 weeks old male Wistar Hanlbm rats.
- Test concentrations with justification for top dose:
- 10 - 5000 ug/plate
- Vehicle / solvent:
- deionised water
Controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- no
- Details on test system and experimental conditions:
- The experiments were performed to assess the potential of the test item to induce gene
mutations by means of two independent Salmonella typhimurium reverse mutation assays.
Experiment I was performed as a plate incorporation assay. Since a negative result was
obtained in this experiment, experiment II was performed as a pre-incubation assay. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of
revertants exceeding the threshold of twice (strains TA 98, TA 100, and TA 102) or thrice
(strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is
observed (3).
A dose dependent increase is considered biologically relevant if the threshold is exceeded
at more than one concentration (2).
An increase exceeding the threshold at only one concentration is judged as biologically
relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is
regarded as an indication of a mutagenic potential if reproduced in an independent second
experiment. However, whenever the colony counts remain within the historical range of
negative and solvent controls such an increase is not considered biologically relevant.
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium strains: TA 1535, TA 1537, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Toxic effects, evident as a reduction in the number of revertants, were observed at higher concentrations in strains TA 98, TA 100 and TA 102 without metabolic activation in experiment I.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The plates incubated with the test item showed normal background growth up to
5000 mg/plate with and without S9 mix in all strains used with the exception of strain TA
102 where a reduction of the background growth was observed at 5000 mg/plate without
metabolic activation in experiment I. - Remarks on result:
- other: strain/cell type: Salmonella typhimurium strains: TA 1535, TA 1537, TA 98, TA 100, TA 102
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Toxic effects, evident as a reduction in the number of revertants, were observed at higher concentrations in strains TA 98, TA 100 and TA 102 without metabolic activation in experiment I.
No substantial increase in revertant colony numbers of any of the five tester strains was
obsewed following treatment with KN 172 at any dose level, neither in the presence nor
absence of metabolic activation (S9 mix) with the exception of strain TA 98 without
metabolic activation in experiment I where a slight increase in revertant colonies was
obsewed at 2500 and 5000 mg/plate. However, this effect could not be reproduced in an
independent experiment. There was also no tendency of higher mutation rates with
increasing concentrations in the range below the generally acknowledged border of
biological relevance.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Therefore, KN 172 is considered to be non-mutagenic in this Salmonella typhimurium
reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of KN 172 to induce gene mutations
according to the plate incorporation test (experiment I) and the pre-incubation test
(experiment II and II A) using the Salmonella typhimurium strains TA 1535, TA 1537,
TA 98, TA 100, and TA 102.
The assay was performed with and without liver microsomal activation. Each
concentration, including the controls, was tested in triplicate. The test item was tested at
the following concentrations:
10, 33; 100; 333; 1000; 2500; and 5000 pglplate
The plates incubated with the test item showed normal background growth up to
5000 pglplate with and without S9 mix in all strains used with the exception of strain TA
102 where a reduction of the background growth was obsewed at 5000 pglplate without
metabolic activation in experiment I.
Toxic effects, evident as a reduction in the number of revertants, were observed at higher
concentrations in strains TA 98, TA 100 and TA 102 without metabolic activation in
experiment I.
No substantial increase in revertant colony numbers of any of the five tester strains was
obsewed following treatment with KN 172 at any dose level, neither in the presence nor
absence of metabolic activation (S9 mix) with the exception of strain TA 98 without
metabolic activation in experiment I where a slight increase in revertant colonies was
obsewed at 2500 and 5000 pglplate. However, this effect could not be reproduced in an
independent experiment. There was also no tendency of higher mutation rates with
increasing concentrations in the range below the generally acknowledged border of
biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase
of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the
experimental conditions reported, the test item did not induce gene mutations by base pair
changes or frameshifts in the genome of the strains used.
Therefore, KN 172 is considered to be non-mutagenic in this Salmonella typhimurium
reverse mutation assay.
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