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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-11-30 to 1998-12-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD guideline 401 and EU Method B1 with acceptable restriction which do not impair the overall conclusion from the data (purity of the test item is missing).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 1) No 95%-CI for LD50; 2) No dose-mortality curve and slope
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Departement of health of the Goverment of the UK
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
- Details on test material:
- - Name of test material: 2-pyrrolidone
- Substance type: no data - identity,
- Analytical purity: purity (Sponsor responsibility)
- Stability under test conditions: stability (responsibility of the Sponsor)
- Physical state: colourless liquid
- Analytical purity: no data
- Expiration date of the lot/batch: no data
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males: 211-235 g/females: 200-225 g
- Fasting period before study: overnight
- Housing: groups of 5 by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum Rat and Mouse expanded diet no. 1 (special diets services limited, Witham, Essex, UK)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 deg C
- Humidity (%): 44-67 %
- Air changes (per hr): 15 air changes per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: no data To: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
1.81 mL/kg (range finding study)
- Doses:
- 2000 mg/kg bw (male, female)
- No. of animals per sex per dose:
- 5 males dosed 2000 mg/kg bw
5 females dosed 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations 0.5, 1, 2, 4 h after dosing and once daily for 14 days/ weighing prior to dosing on day 0 and on days 7 and 14
- Necropsy of survivors performed: yes (at the end of the study the animals were killed by cervical dislocation and subjected to gross pathatological examination)
- Other examinations performed: clinical signs (hunched posture), body weight, histopathology (external examination, opening of abdominal and thoracic cavities for examination of major organs) - Statistics:
- no data
Results and discussion
- Preliminary study:
- Range-finding test with 1 male and 1 female dosed once orally with 2 g/kg revealed reversible clinical effects (hunched posture) 2 days post-dosing
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no deaths
- Clinical signs:
- other: Incidents of hunched posture were noted in all treated animals during the day of dosing and persisted in one male on Day 1. All animals appeared normal two days after treatment (Table 1 in "Remarks on results")
- Gross pathology:
- no abnormalities
- Other findings:
- no data
Any other information on results incl. tables
Table 1: Individual Clinical Observations and Mortality Data
Dose level |
Animal |
Effects noted after dosing (hours) |
Effects noted during period after dosing (days) |
||||||||||||||||
(mg/kg) |
No. |
0,5 |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
2000 |
Male 3-0 |
0 |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Male 3-1 |
0 |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Male 3-2 |
H |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Male 3-3 |
0 |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Male 3-4 |
0 |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Female 4-0 |
H |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Female 4-1 |
H |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Female 4-2 |
0 |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Female 4-3 |
0 |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Female 4-4 |
0 |
H |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = no signs of systemic toxicity
H = hunched posture
Applicant's summary and conclusion
- Interpretation of results:
- other: EU-GHS criteria not met
- Conclusions:
- Acute oral median lethal dose (LD50) of 2-pyrrolidone in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute oral toxicicty of the test material in the Sprague-Dawley CD strain rat. The method of the study is according to the OECD Guideline 401 and is compliant to the GLP requirements.
A single oral dose of undiluted test material at dose level of 2000 mg/kg/bw was given to a group of ten fasted animals. The animals were observed within 14 days for signs of toxicity.
There were no deaths. Incidents of hunched posture were noted in all treated animals during the day of dosing. All animals appeared to be normal one to two days after treatment. No abnormalities were noted at necropsy.
The LD50 was found to be greater than 2000 mg/kg/bw.
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