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EC number: 601-093-6 | CAS number: 111453-32-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation (bacterial reverse mutation assay / Ames test, GLP, OECD TG 471): negative with and without metabolic activation (preincubation and direct plate incorporation method)
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:
- March 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- yes
- Remarks:
- no bacteria strain included to detect cross-linking mutagens (e.g. TA 102)
- Principles of method if other than guideline:
- modified Ames test with preincubation for 60 min at 37°C
No E. coli WP2 or S. typhimurium TA102 strain tested. This requirement was first formulated in the adoption of the guideline in 1997 and thus the study was conducted prior to implementation. - GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine gene locus
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from Aroclor 1254-induced rat liver
- Test concentrations with justification for top dose:
- 0.10, 0.25, 0.50, 1.00, 2.50 and 5.0 mg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and phosphate buffer pH 7.4, 0.1 mol/l
- Positive controls:
- yes
- Positive control substance:
- other: 9-Acridinamine, hydrochloride; 2-Aminoanthracene; 2-Nitrofluorene; Benzo[a]pyrene; Sodium azide; Cyclophosphamide
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: one
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition - Evaluation criteria:
- The plates were scored for the number of mutant colonies with an automated colony counter (Artek M 982B, Artek Systems Corporation, Farmingdale, NY, USA). The arithmetic means of the number of mutant colonies of the 3 parallel plates in the negative control groups were compared with those of the compound groups. A positive response was considered if at least 5 mg/plate or up to a toxic dose had been tested (or the compound formed precipitates in the agar) and if the number of induced revertants compared to the number of spontaneous ones was reproducibly higher than 2-fold. A dose-dependent increase in the number of revertants was also considered to indicate a mutagenic effect.
- Key result
- Species / strain:
- other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 1538, TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
Tamip monoamide is not mutagenic under the conditions of this test system - Executive summary:
Tamip monoamide (ZK 39211) did not show any mutagenic potential in a bacterial reverse mutation assay with S. typhymurium (TA 1535, TA 100, TA 1537, TA 1538, TA 98) when tested with preincubation up to 5.0 mg/plate in the absence and presence of intrinsic metabolic activation (liver mix from Aroclor 1254 -treated rat)
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- Deviations:
- yes
- Remarks:
- no bacteria strain included to detect cross-linking mutagens (e.g. TA 102)
- Principles of method if other than guideline:
- Direct plate incorporation procedure was performed. No E. coli WP2 or S. typhimurium TA102 strain tested; no preincubation test performed. These requirements were first formulated in the adoption of the guideline in 1997 and thus the study was conducted prior to implementation of these requirements.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine gene locus
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538 and TA 98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver mix from Aroclor 1254 -treated rat
- Test concentrations with justification for top dose:
- 0.10, 0.25, 0.50, 1.00, 2.50 and 5 mg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 9-Acridinamine, hydrochloride; 2-Aminoanthracene; 2-Nitrofluorene; Benzo[a]pyrene; Sodium azide; Cyclophosphamide
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: one
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition - Evaluation criteria:
- The plates were scored for the number of mutant colonies with an automated colony counter (Artek M 982B, Artek Systems Corporation, Farmingdale, NY, USA). The arithmetic means of the number of mutant colonies of the 3 parallel plates in the negative control groups were compared with those of the compound groups. A positive response was considered if at least 5 mg/plate or up to a toxic dose had been tested (or the compound formed precipitates in the agar) and if the number of induced revertants compared to the number of spontaneous ones was reproducibly higher than 2-fold. A dose-dependent increase in the number of revertants was also considered to indicate a mutagenic effect.
- Key result
- Species / strain:
- other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 1538, TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
Tamip monoamide is not mutagenic under the conditions of this test system - Executive summary:
Tamip monoamide (ZK 39211) did not show any mutagenic potential in a bacterial reverse mutation assay with S. typhymurium (TA 1535, TA 100, TA 1537, TA 1538, TA 98) when tested up to 5.0 mg/plate in the absense and presense of intrinsic metabolic activation (liver mix from Aroclor 1254 -treated rats)
Referenceopen allclose all
Growth inhibition of the background lawn was not observed. There were no precipitates in the agar.
Growth inhibition of the background lawn was not observed. There were no precipitates in the agar.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Tamip monoamide (ZK 39211) did not show any mutagenic potential in a bacterial reverse mutation assay with S. typhymurium (TA 1535, TA 100, TA 1537, TA 1538, TA 98) when tested up to 5.0 mg/plate in the absense and presense of intrinsic metabolic activation (liver mix from Aroclor 1254 -treated rats) (Schering AG, Report No. A483; 1993-06-28)
Tamip monoamide (ZK 39211) did not show any mutagenic potential in a bacterial reverse mutation assay with S. typhymurium (TA 1535, TA 100, TA 1537, TA 1538, TA 98) when tested with preincubation up to 5.0 mg/plate in the absense and presense of intrinsic metabolic activation (liver mix from Aroclor 1254 -treated rat) (Schering AG, Report No. A556; 1993-08-12)
Short description of key information:
Gene mutation (Bacterial reverse muation assay/AMES test, GLP): negative with and without metabolic activation
[Schering AG, Report No. A483; 1993-06-28]
Gene mutation (Bacterial reverse muation assay/AMES test, GLP): negative with and without metabolic activation
[Schering AG, Report No. A556; 1993-08-12]
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Tamip monoamide was tested in two standard genotoxicity tests and did not show any genotoxic potential.
Tamip monoamide is not classified as genotoxic according to the German legislation (TRGS-905).
Classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.
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.
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