Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 244-942-2 | CAS number: 22374-89-6
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Prediction model based estimation and data from read across chemical have been reviewed to determine the mutagenic nature of 1-methyl-3-phenylpropylamine (22374-89-6). The studies are as mentioned below
Gene mutation toxicity was predicted for 1-methyl-3-phenylpropylamine using the battery approach from Danish QSAR database (2018). The study assumed the use of Salmonella typhimurium bacteria in the Ames test. The end point for gene mutation has been modeled in the Danish QSAR using the three software systems Leadscope, CASE Ultra and SciQSAR. Based on predictions from these three systems, a fourth and overall battery prediction is made. The battery prediction is made using the so called Battery algorithm. With the battery approach it is in many cases possible to reduce “noise” from the individual model estimates and thereby improve accuracy and/or broaden the applicability domain. Gene mutation toxicity study as predicted by Danish QSAR for1-methyl-3-phenylpropylamine is negative and hence the chemical is predicted to classify as a gene mutant in vitro.
The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. In the study conducted by Mortelmans et al in 1986,test chemical was examined for its ability to cause mutagenic changes when tested in five strains of the bacteria Salmonella typhimurium, specifically, TA 1535, TA 1537, TA97, TA 98 and TA 100 through the preincubation assay method. The test was conducted both in the presence and absence of metabolic activation using rat and hamster liver derived S-9 mix, over a range of doses, from 0 to 10000 ug/plate. Based on the results of this study, the test substance was not considered to be mutagenic under the conditions of this test.
The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. The test substance did not induce mutagenicity in an Ames assay conducted on S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains with and without rat liver S9 activation. Although positive response is observed in some strains, there were also no apparent trends discernible that would suggest a change in mutagenic activity caused by the addition of the ingredients. Hence the test chemical cannot be classified as mutagenic
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
- Reason / purpose for cross-reference:
- other: Prediction
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- WoE derived based on the predicted data for the target chemical and experimental data from structurally and functionally similar read across chemicals
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other:
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98,TA 97 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- not specified
- Metabolic activation system:
- not specified
- Test concentrations with justification for top dose:
- 1; No data
2;0,10,100,1000 and 10000ug/plate.
3;five doses up to 5 mg mainstream smoke condensate (MSC)/plate - Vehicle / solvent:
- 1;No data
2;water or DMSO
3;water or DMSO - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-o-phenylenediamine-Used with metabolic activation for strain TA 98 9-aminoacridine- Used with metabolic activation for strains TA 97 and TA 1537 2-aminoanthracene-Used with all strains with rat and hamster liver metabolic activation systems.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- 1.No data
2.Details on test system and conditions
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk: preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
- Expression time (cells in growth medium):No data available
- Selection time (if incubation with a selection agent): :No data available
- Fixation time (start of exposure up to fixation or harvest of cells): :No data available
SELECTION AGENT (mutation assays): :No data available
SPINDLE INHIBITOR (cytogenetic assays): :No data available
STAIN (for cytogenetic assays): :No data available
NUMBER OF REPLICATIONS: : All assays were repeated no less than one week after completion of the initial test.
NUMBER OF CELLS EVALUATED: :No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Toxicity was evidenced by one or more of the following phenomena: appearance of his- pinpoint colonies, reduced numbers of revertant colonies per plate or thinning or absence of the bacterial lawn.
OTHER EXAMINATIONS:
- Determination of polyploidy: :No data available
- Determination of endoreplication: :No data available
- Other: :No data available
OTHER: At least one toxic dose was incorporated into the first mutagenicity test, the repeat test(s) occasionally had the doses adjusted so that an apparent toxic dose was not reached.
3.METHOD OF APPLICATION: in agar (plate incorporation)
For plating, approximately 10(8) bacteria suspended in 100 ml culture medium, 120 ml of the MSC dissolved in DMSO or DMSO alone, 500 ml S9 mix or 0.1 mol/l phosphate buffer, pH 7.4, were added to 2 ml of top agar supplemented with histidine and biotin (0.05 nmol each). The components were mixed and spread evenly on minimal glucose agar plates. After the top agar hardened, the plates were incubated in the dark at 361C for 44–48 h. The number of His+ revertant colonies was determined with an automatic colony counter. In all experiments several negative and positive strain-specific and S9-specific control substances were assayed concurrently. - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- 1. No data
2.Mutagenic response: a dose-related, reproducible increase in the number of revertants over background, even if the increase was less than twofold.
Nonmutagenic response: when no increase in the number of revertants was elicited
Questionable response: when there was an absence of a clear cut dose related increase in revertants, when the dose related increase in revertants was not reproducible or when the response was of insufficient magnitude to support a determination of mutagenicity.
3.The normal mutagenic response to MSC is characterized by a linear increase in the number of revertants as the amount of MSC is increased. This is followed by a leveling or decrease in response due to toxicity. - Statistics:
- 1.No data
2.Not specified
3.The mutagenic response reported here was calculated as the slope (revertants/mg TPM) of the linear portion of the dose–response curve fitted with Poisson-weights to the data. A single slope was calculated for each of the four batches. - Species / strain:
- S. typhimurium, other:
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98,TA 97 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102, TA1535 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic effect were observed based on prediction
- Conclusions:
- Gene mutation toxicity study for 1-methyl-3-phenylpropylamine (22374-89-6) as predicted using data from read across chemicals for Salmonella typhimurium bacterial strains in the presence and absence of S9 metabolic activation system is negative and hence the chemical is not likely to classify as a gene mutant in vitro.
- Executive summary:
Genetic mutation in vitro;
Prediction model based estimation and data from read across chemical have been reviewed to determine the mutagenic nature of 1-methyl-3-phenylpropylamine (22374-89-6). The studies are as mentioned below
Gene mutation toxicity was predicted for 1-methyl-3-phenylpropylamine using the battery approach from Danish QSAR database (2018). The study assumed the use of Salmonella typhimurium bacteria in the Ames test. The end point for gene mutation has been modeled in the Danish QSAR using the three software systems Leadscope, CASE Ultra and SciQSAR. Based on predictions from these three systems, a fourth and overall battery prediction is made. The battery prediction is made using the so called Battery algorithm. With the battery approach it is in many cases possible to reduce “noise” from the individual model estimates and thereby improve accuracy and/or broaden the applicability domain. Gene mutation toxicity study as predicted by Danish QSAR for1-methyl-3-phenylpropylamine is negative and hence the chemical is predicted to classify as a gene mutant in vitro.
The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. In the study conducted by Mortelmans et al in 1986,test chemical was examined for its ability to cause mutagenic changes when tested in five strains of the bacteria Salmonella typhimurium, specifically, TA 1535, TA 1537, TA97, TA 98 and TA 100 through the preincubation assay method. The test was conducted both in the presence and absence of metabolic activation using rat and hamster liver derived S-9 mix, over a range of doses, from 0 to 10000 ug/plate. Based on the results of this study, the test substance was not considered to be mutagenic under the conditions of this test.
The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. The test substance did not induce mutagenicity in an Ames assay conducted on S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains with and without rat liver S9 activation. Although positive response is observed in some strains, there were also no apparent trends discernible that would suggest a change in mutagenic activity caused by the addition of the ingredients. Hence the test chemical cannot be classified as mutagenic
Based on the data available for the target chemical and its read across substance and applying weight of evidence1-methyl-3-phenylpropylamine (22374-89-6) does not exhibit gene mutation in vitro . Hence the test chemical is not likely to classify as a gene mutant in vitro.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic mutation in vitro;
Prediction model based estimation and data from read across chemical have been reviewed to determine the mutagenic nature of 1-methyl-3-phenylpropylamine (22374-89-6). The studies are as mentioned below
Gene mutation toxicity was predicted for 1-methyl-3-phenylpropylamine using the battery approach from Danish QSAR database (2018). The study assumed the use of Salmonella typhimurium bacteria in the Ames test. The end point for gene mutation has been modeled in the Danish QSAR using the three software systems Leadscope, CASE Ultra and SciQSAR. Based on predictions from these three systems, a fourth and overall battery prediction is made. The battery prediction is made using the so called Battery algorithm. With the battery approach it is in many cases possible to reduce “noise” from the individual model estimates and thereby improve accuracy and/or broaden the applicability domain. Gene mutation toxicity study as predicted by Danish QSAR for1-methyl-3-phenylpropylamine is negative and hence the chemical is predicted to classify as a gene mutant in vitro.
The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance for test substance. In the study conducted by Mortelmans et al in 1986,test chemical was examined for its ability to cause mutagenic changes when tested in five strains of the bacteria Salmonella typhimurium, specifically, TA 1535, TA 1537, TA97, TA 98 and TA 100 through the preincubation assay method. The test was conducted both in the presence and absence of metabolic activation using rat and hamster liver derived S-9 mix, over a range of doses, from 0 to 10000 ug/plate. Based on the results of this study, the test substance was not considered to be mutagenic under the conditions of this test.
The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance for target substance. The test substance did not induce mutagenicity in an Ames assay conducted on S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 strains with and without rat liver S9 activation. Although positive response is observed in some strains, there were also no apparent trends discernible that would suggest a change in mutagenic activity caused by the addition of the ingredients. Hence the test chemical cannot be classified as mutagenic
Based on the data available for the target chemical and its read across substance and applying weight of evidence1-methyl-3-phenylpropylamine (22374-89-6) does not exhibit gene mutation in vitro . Hence the test chemical is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Thus based on above annotation and CLP criteria the target chemical 1-methyl-3-phenylpropylamine (22374-89-6) does not exhibit gene mutation in vitro . Hence the test chemical is not likely to classify as a gene mutant in vitro.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)