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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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus 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
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Details on exposure:
- Single intraperitoneal administration with a volume of 10 mL/kg body weight.
- Duration of treatment / exposure:
- 16, 24 and 48 hours
- Frequency of treatment:
- single
- Post exposure period:
- - Sacrifice intervals per dose-group were:
2000 mg/kg: 16, 24 and 48 hours
1000 mg/kg: 24 hours
500 mg/kg: 24 hours
Controls: 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day
- Remarks:
- intraperitoneal
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- intraperitoneal
- Dose / conc.:
- 2 000 mg/kg bw/day
- Remarks:
- intraperitoneal
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 20 mg cyclophosphamide/kg bw or 0.15 mg vincristine/kg bw, both dissolved in distilled water
Examinations
- Tissues and cell types examined:
- bone marrow, erythrocytes (see below in "Details of tissue and slide preparation"
- Details of tissue and slide preparation:
- - Preparation of bone marrow: After cutting off the epiphyses, the bone marrow was flushed out of the diaphysis into a centrifuge tube using a cannula filled with fetal calf serum which was at 37 °C (about 2 mL/femur). The suspension was mixed thoroughly with a pipette, centrifuged at 1500 rpm for 5 minutes, the supernatant removed and the cells were resuspended. One drop of this suspension was dropped onto clean microscopic slides.
Smears were prepared using slides with ground edges, the preparations were dried in the air and subsequently stained in eosin and methylene blue solution for 5 minutes, rinsed, placed in fresh distilled water for 2 or 3 minutes and finally stained in Giemsa solution for 12 minutes. After being rinsed twice and clarified with xylene, the preparations were embedded in Corbit-Balsam. Slides were coded before microscopic analysis.
-Evaluations: In general, 1000 polychromatic erythrocytes from each male and female animal of every test group was evaluated and investigated for micronuclei. The normochromatic erythrocytes which occur were also scored. The following parameters were recorded:
Number of polychromatic erythrocytes
Number of polychromatic erythrocytes containing micronuclei,
Number of normochromatic erythrocytes,
Number of normochromatic erythrocytes containing micronuclei,
Ratio of polychromatic to normochromatic erythrocytes,
Number of small micronuclei (d < D/4) and of large micronuclei (d >= D/4)
CRITERIA FOR DOSE SELECTION:
Doses were selected on the basis of a preliminary toxicity study: Here, a dose of 2000 mg/kg bw led to signs of toxicity including irregular respiration, piloerection abdominal position, apathy and squatting posture; the general state was poor. - Statistics:
- No statistical methods were employed in data analysis.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- observed in the highest dose tested
Any other information on results incl. tables
CLINICAL EXAMINATIONS
The single intraperitoneal administration of the solvent in a volume of
10 mL/kg body weight was tolerated by all animals without any signs or
symptoms. A dose of 2000 mg/kg bw. of test substance led to irregular
respiration, piloerection, abdominal position and apathy about 30
minutes after administration; the general state of some animals was
poor. After treatment of the animals with 1000 or 500 mg/kg, only
irregular respiration and piloerection were observed after about 30
minutes. After about 1 -2 hours clinical signs were no longer observed.
None of the positive control substances caused any evident signs of
toxicity.
MICRONUCLEI
Mean polychromatic (normochromatic) erythrocytes containing micronuclei
were:
Negative control (24 hrs) 1.5 % (1.5 %)
2000 mg/kg (16 hrs) 1.2 % (1.1 %)
2000 mg/kg (24 hrs) 1.7 % (0.25 %)
2000 mg/kg (48 hrs) 1.6 % (1.29 %)
1000 mg/kg (24 hrs) 2.4 % (1.0 %)
500 mg/kg (16 hrs) 1.2 % (0.26 %)
Cyclophosphamide (24 hrs) 13.6 % (2.33 %)
Vincristine (24 hrs) 83.2 % (1.72 %)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Cytogenetic analysis of bone marrow cells of mice in vivo show negative results. - Executive summary:
To assess the cytotoxicity, 2 -pyrrolidone was tested in the Micronucleus Test in Mice in vivo. The study was conducted according to the OECD Guideline 474 and is compliant to GLP requirements.
Administration of test substance did not lead to any increase in the rate of micronuclei. The number of normochromatic or polychromatic erythrocytes containing small micronuclei (d D/4) or large micronuclei (d > D/4) did not deviate from the solvent control value at any sacrifice interval. No inhibition of erythropoiesis induced by the treatment of mice with Pyrrolidon-2 was detected; the ratio of polychromatic to normochromatic erythrocytes was always in the same range as that of the control values in all dose groups. The number of normochromatic erythrocytes containing micronuclei did not differ to any appreciable extent in the negative control or in the various dose groups at any of the sacrifice intervals.
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