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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 210-483-1 | CAS number: 616-45-5
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study (GLP) with acceptable restrictions (strain combination not suitable for the detection of cross links)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
- Principles of method if other than guideline:
- According to Ames et al. Mut. Res., 31, 347-364, 1975
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-pyrrolidone
- EC Number:
- 210-483-1
- EC Name:
- 2-pyrrolidone
- Cas Number:
- 616-45-5
- Molecular formula:
- C4H7NO
- IUPAC Name:
- pyrrolidin-2-one
Constituent 1
Method
- Target gene:
- his-
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver
- Test concentrations with justification for top dose:
- 0, 110, 1100, 5500, 11000, 27500, 55000, 110000 and 165000 µg/plate (= 0, 0.1, 1.0, 5.0, 10, 25, 50, 100 and 150 µL/plate)
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- other: without metabolic activation: Quinacrine mustard and with metabolic activation: 2-Anthramine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- Evaluations considered if a dose-response was observed and strain-specific evaluation criteria. For strains TA-1535, TA-1537 and TA-1538, the data set is evaluated as positive if a dose-response is observed over a minimum of three test concentrations and the increase in revertants is equal to or greater than three times the solvent control value at the peak of the dose-response. The solvent control value should be within the normal range for evaluating the results. For strains TA-98 and TA-100, the data set is evaluated as positive if a dose-response is observed over a minimum of three test concentrations and the increase in revertants achieves a doubling of the solvent control value at the peak of the dose-response. The solvent control value should be within the normal range for evaluating the results.
- Statistics:
- Formal statistical methods were not used to evaluate the data.
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA1535, TA1537, TA1538, TA98, TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 165000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Standard plate test (110-16500 µg/plate) | |||||
Strain | Metabolic activation system | mean revertants in Controls | maximum revertant factor | dose dependency | Assessment |
TA 98 | no | 25.7 | 1.2 | no | negative |
yes | 46.3 | 1.0 | no | negative | |
TA 100 | no | 147.7 | 1.0 | no | negative |
yes | 140.3 | 1.0 | no | negative | |
TA 1535 | no | 25.3 | 1.0 | no | negative |
yes | 17.3 | 1.0 | no | negative | |
TA 1537 | no | 5 | 1.7 | no | negative |
yes | 10.3 | 1.1 | no | negative | |
TA 1538 | no | 13 | 1.1 | no | negative |
yes | 16 | 1.8 | no | negative | |
Standard plate test II(110-16500 µg/plate) | |||||
Strain | Metabolic activation system | mean revertants in Controls | maximum revertant factor | dose dependency | Assessment |
TA 98 | no | 28.3 | 1.1 | no | negative |
yes | 49 | 1.0 | no | negative | |
TA 100 | no | 127 | 1.2 | no | negative |
yes | 142.7 | 1.1 | no | negative | |
TA 1535 | no | 20.7 | 1.2 | no | negative |
yes | 15 | 1.2 | no | negative | |
TA 1537 | no | 7.7 | 1.6 | no | negative |
yes | 12 | 1.0 | no | negative | |
TA 1538 | no | 12 | 1.2 | no | negative |
yes | 22 | 1.2 | no | negative |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
2-Pyrrolidone is negative in this Ames Test - Executive summary:
The test item was examined in the 5 Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver).
The experiments were carried out as plate incorporation tests. The test item was completely dissolved in distilled water. The solvent served as the negative control.
Preliminary test
Concentrations of test substance were selected based on a preliminary toxicity assay at 14 concentration levels using two-fold dilutions from a high concentration of 150 microliter per plate (for liquids). As no significant toxicity was observed, 150 microliters per plate was used as the top concentration in the studies.
Main study
Eight concentrations ranging from 0.1 to 150 μL test substance/plate were employed in the plate incorporation test (in detail the following concentrations were employed: 0, 0.1, 1.0, 5.0, 10, 25, 50, 100 and 150 microliters per plate for all strains in both of the two independent repeats: with and without metabolic activation).
Cytotoxicity was noted in the plate incorporation test, carried out without and with metabolic activation at 165000 µg/plate..
No increase in revertant colony numbers as compared with control counts was observed for the test substance, tested up to a concentration of 150 μL/plate, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively. The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
In conclusion, under the present test conditions the test substance 2 -pyrrolidone tested up to a concentration of 150 µL/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the plate incorporation test carried out without and with 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.