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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-466-3 | CAS number: 26116-12-1
- 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 cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 June - 25 July 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study but no informations on GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 487 dated 22 July 2010
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- 1-ethylpyrrolidin-2-ylmethylamine
- EC Number:
- 247-466-3
- EC Name:
- 1-ethylpyrrolidin-2-ylmethylamine
- Cas Number:
- 26116-12-1
- Molecular formula:
- C7H16N2
- IUPAC Name:
- 1-ethylpyrrolidin-2-ylmethylamine
- Test material form:
- solid - liquid: suspension
- Details on test material:
- Test article identification: PE0851 [(1-ethyl 2-pyrrolidinyl) methanamine]
Test article batch number: DS00001
Certificate of analysis: Purity: > 98%
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- First test without metabolic activation: 10 to 1500 µg/mL
Second test without metabolic activation: 100 to 600 µg/mL
Test with metabolic activation: 10 to 1500 µg/mL - Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- dimethyl sulfoxide (DMSO)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulfoxide (DMSO)
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- dimethyl sulfoxide (DMSO)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethyl sulfoxide (DMSO)
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- With S9-mix
- Details on test system and experimental conditions:
- L5178Y cells were treated with the test article in 96-well microtiter plates for 3 hours with metabolic activation and for 28 hours without metabolic activation. Without metabolic activation the cells were harvested directly after the treatment time and with metabolic activation 21 hours (recovery time) after the end of the treatment. Cells were then fixed and stained with Giemsa, then scored manually.
The cytotoxicity of the test article was evaluated by the population doubling (PD), expressed as a percentage of the negative control (relative population doubling): PD = (log (Cf /C0 )) / log 2
Cf = final cell count (24 hours after the start of treatment with metabolic activation or 28 hours without metabolic activation)
C0 = initial cell count
The ability of the test article to induce structural/numerical chromosome damage is evaluated by the increase in the number of micronucleated mononucleated cells, scored out of 1000 mononucleated cells. - Evaluation criteria:
- Experiment acceptance criteria
The experiment is considered valid when all the following criteria are fulfilled:
• the population doubling of the negative control is higher or equal to 1.5 but not higher than 2.2;
• the number of micronucleated cells per 1000 cells in the concurrent solvent control is lower than or equal to the acceptable upper value for historical solvent control data (99% percentile of our historical negative control data):
- 7 for 28-hour treatment without S9-mix;
- 11 for 3-hour treatment with S9-mix.
• the positive controls induce a marked increase in the number of micronucleated cells;
• at least three analyzable concentrations are scored;
• the highest concentration evaluated corresponds either to 5000 µg/mL (or 10 mM), or to the solubility limit in the solvent, or to the lowest precipitating concentration in the culture medium or to 50% to 60% of cell cytotoxicity.
Test evaluation criteria
A test article is considered to induce a positive response in the in vitro micronucleus test if the two criteria listed below are fulfilled for at least one concentration:
• the test article induces a statistically significant increase in the number of micronucleated cells for a given concentration;
• for this concentration, this value is strictly above positive threshold value (99% percentile of our historical negative control data):
- 7 for 28-hour treatment without S9-mix;
- 11 for 3-hour treatment with S9-mix.
When none of the above criteria are fulfilled, the test article is considered negative.
Results which only partially satisfy one of the above positivity criteria are dealt on a case by case basis, taking into account the concentration relationship, the reproducibility and the biological relevance.
- Statistics:
- Statistical analysis is performed using the pairwise Fisher exact test with Bonferroni-Holm correction.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- A dose related increase (>7) in the number of micronucleated cells was observed as from 200 µg/mL with a statistical significance at 400 µg/mL.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The top concentration retained for scoring was 400 µg/mL (41% cytotoxicity) as the slides of higher concentrations were unreadable due to damaged cells (indicating severe cytotoxicity). Evaluated concentrations were 100, 200 and 400 µg/ml.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- A statistically significant increase (>7) in the number of micronucleated cells was observed at 500 µg/mL.
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- The top concentration retained for scoring was 500 µg/mL (35% cytotoxicity) as the slides of higher concentrations were unreadable due to damaged cells (indicating the severe cytotoxicity). Evaluated concentrations were 200, 400 and 500 µg/mL.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Test with metabolic activation: at the beginning of treatment, as the pH of the concurrent negative control was 7.5, the pH of the top dose should not be higher than 8.5 which was obtained at 1000 µg/mL. Evaluated concentrations were 100, 500 and 1000 µg/ml. The population doubling of the negative control was slightly higher than 2.2, but this was considered acceptable.
First test without metabolic activation: binucleated cells and vacuoles in cells were observed from 200 µg/mL.
Second test without metabolic activation: presence of vacuoles in cells as from 200 µg/mL.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive without metabolic activation
Under the experimental conditions of this study, PE0851 [(1-ethyl 2-pyrrolidinyl) methanamine] was found positive in the exploratory in vitro micronucleus test in mouse lymphoma cells in the absence of metabolic activation and was found negative in the presence of metabolic activation.
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.