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EC number: 220-250-6 | CAS number: 2687-91-4
- 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
Endpoint summary
Administrative data
Description of key information
1-Ethyl-pyrrolidin-2 -one (NEP) is
practically non-toxic after acute inhalative or dermal exposure. After
ingestion NEP is of low acute toxicity.
LD50 (rat; oral) : 3200 mg/kg
LC50 (rat; inhal.): > 5.1 mg/l/4h
LD50 (rat; dermal): > 2000 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP study and non-guideline study, but basic information given
- Principles of method if other than guideline:
- similar to OECD 401
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The mean body weights for males was 208 g and for females 165 g.
The animals were offered Herilan MRH concentrated feed and water ad libitum. Feed was withdrawn 16 hours before the beginning of the study. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 10.0; 21.5; 31.6 and 50% solution in distilled water in doses of 1,000; 2,150; 3,160 and 5,000 mglkg
- No. of animals per sex per dose:
- 5
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 200 mg/kg bw
- Mortality:
- see below
- Clinical signs:
- other: see below
- Gross pathology:
- Animals that died: Heart: acute dilatation; kidneys: some of them pale; lungs: infarctoid congestion with edematization; intestines: atonic
Sacrificed animals: Organs: no abnormalities detected
Reference
Mortality:
Dose (mg/kg) | Conc. (%) | No. of animals | Died within | ||||
1 hour | 24 hours | 48 hours | 7 days | 14 days | |||
5,000 | 50 | 5 males | 0/5 | 5/5 | 5/5 | 5/5 | 5/5 |
5 females | 0/5 | 3/5 | 4/5 | 4/5 | 4/5 | ||
3,160 | 31.6 | 5 males | 0/5 | 0/5 | 1/5 | 1/5 | 1/5 |
5 females | 0/5 | 2/5 | 4/5 | 4/5 | 4/5 | ||
2,150 | 21.5 | 5 males | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
5 females | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 | ||
1,000 | 10.0 | 5 males | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
5 females | 0/5 | 0/5 | 0/5 | 0/5 | 0/5 |
Symptoms:
5,000 mg/kg | 3,160 mg/kg | 2,150 mg/kg | 1,000 mg/kg | |
Dyspnea | 15 min - 6 d | < 15 min - 4 h | 1 h - 5 h | |
Apathy | 15 min - 5 d | < 15 min - 4 h | 1 h - 5 h | |
Lateral position | 1 h - 2 d | 30 min - 4 h | ||
Abdominal position | 30 min - 4 h | 2 h - 4 h | ||
Dorsal position | 4 h | |||
Staggering | 15 min - 1 d | < 15 min - 4 h | ||
Atony | 1 h - 4 h | |||
Paresis | 15 min - 2 d | |||
Pain reflex absesnt | 1 h | |||
Narcotic-like state | 1 h | |||
Urine orange | 1 d - 5 d | |||
Erythema | 1 h - 2 d | |||
Exsiccosis | 1 h - 2 d | |||
Ames blood test | 15 min - 6 d | < 15 min - 4 h | 1 h - 5 h |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Only animals free from clinical signs of disease were used for the study. The females were nulliparous and non-pregnant. The animals were subjected to an acclimatization period of at least 1 week in which they were adapted to the surroundings. Age of the animals at the beginning of the study was approx . 8 - 10 weeks for males and approx. 11 - 13 weeks for females. The animals were identified individually numbered consecutively on the tail. The feed used in the study was assayed for chemical as well as for microbiological contaminants. The drinking water is regularly assayed for chemical contaminants by the municipal authorities as well as for the presence of microbes. The animals were kept in fully air-conditioned rooms in which temperatures in the range of 20 - 24°C and relative humidities in the range of 30 - 70% were regulated by means of a central air-conditioning system. The animals were housed singly in cages type DK III without bedding, with a light/dark cycle of 12 hours.
- Route of administration:
- inhalation
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: The test substance was doses unchanged. A liquid aerosol was generated.
- Details on inhalation exposure:
- Considering the vapor pressure of the test substance, the test atmosphere was supposed to be a mixture of vapor and liquid aerosols.
After the exposure, the animals were observed for 14 days.
The body weight of the animals was determined just prior to exposure (day 0), weekly thereafter and at the end of the observation period. A check for overt clinical signs of toxicity or mortality as well as a check for the presence of feed and drinking water was made twice a day on workdays and once daily on weekends and public holidays. Detailed clinical observations were recorded for each animal separately several times during exposure and at least once on each workday of the observation period. At the end of the observation period the animals were sacrificed with CO2 and were subjected to gross-pathological examination. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.1 mg/l
- No. of animals per sex per dose:
- 5
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.1 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: aerosol
- Mortality:
- No mortality occurred at the tested concentration.
- Clinical signs:
- other: Clinical signs of toxicity comprised visually accelerated respiration, squatting posture, piloerection, smeared and contaminated fur. Findings were observed from hour 0 of exposure until including study day 1.
- Body weight:
- The mean body weights of the male and female animals did not increase adequately during the first post exposure observation week, but increased during the second week.
- Gross pathology:
- No gross pathological abnormalities were noted in the animals necropsied at termination of the post exposure observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Female animals were nulliparous and non-pregnant. Individual identification by cage cards and tail marking. The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 - 24°C for temperature and of 30 - 70% for relative humidity. There were no deviations from these ranges, which influenced the results of the study. Day/night rhythm: 12h/12h. Stainless steel wire mesh cages were used and the animals were housed singly. Diet was Kliba-Labordiät, water was available ad libitum. Acclimatization for at least 5 days. Clipping of the fur about 24 hours before the beginning of the study.
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test material was applied to the clipped skin (dorsal and dorsolateral parts of the trunk). Application area about 40 cm2 (corresponds to at least 10% of the body surface).
Observation period at least 14 days. Body weight determination: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. Scoring of skin findings: Individual readings 30 - 60 minutes after removal of the semiocclusive dressing (day 1), as a rule weekly thereafter and at the end of the study (last day of the observation period). A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays. Gross-pathology examination on the last day of the observation period after killing with CO2. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No systemic clinical observations were observed during clinical examination. No local effects were observed.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined at termination of the study.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
In an oral toxicity study, comparable to OECD 401, rats (5/sex/dose) were given 1000, 2150, 3160 and 5000 mg/kg 1-Ethyl-pyrrolidin-2 -one (NEP) in water by gavage. No mortality was observed at 1000 and 2150 mg/kg. No clinical signs were noted at 1000 mg/kg but in the 2150 mg/kg dose group dyspnea and apathy were observed: Clinical signs were reversible within 24 h. At higher concentration mortality and severe clinical signs like dyspnea, apathy, abdominal position and CNS effects (staggering, paresis, narcotic-like state). In animals that died pale kidneys were noted. There were no findings in animals that were sacrificed at termination of the study. The LD50 was determined to be about 3200 mg/kg (BASF 1978; reliability 2).
Wistar rats (5/sex) were exposed to 5.1 mg/l NEP (aerosol) for 4 h. The limit test was conducted according to OECD 403 and GLP. No mortality occurred. Clinical signs like accelerated respiration, Squatting posture and a poor general condition on the first day was noted. Body weight gain was reduced. Necropsy revealed no abnormalities (LC50 is > 5.1 mg/l/4h) (BASF 2005, reliability 1).
NEP was administered to Wistar rats (5/sex) in a dermal toxicity study at a dose of 2000 mg/kg according to OECD 402 and GLP. No substance related effect was observed in this limit test. The LD50 is therefore > 2000 mg/kg (BASF 2005, reliability 1).
Justification for classification or non-classification
Classification is not warranted according to the criteria of EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.
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