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EC number: 222-359-4 | CAS number: 3445-11-2
- 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
Acute toxicity data indicate a low toxicity: in rats the oral LD50 was > 7300 mg/kg bw and the dermal LD50 was > 2000 mg/kg bw.
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Gassner
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test substance was administered as 2, 20 or 30% (v/v) aqueous solution.
- Doses:
- 200, 1600, 3200, 6400 mm3/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 6 400 other: mm3/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: original value
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: calculated from original value
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: At the two higest dose levels: restlessness and dyspnea.
- Gross pathology:
- No abnormalities were detected.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males, 8 weeks; females, 12 weeks
- Weight at study initiation: males, 233 g; females, 211 g
- Fasting period before study: no
- Housing: single housing in Makrolon cage, type III
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 40 cm2
- % coverage: 10
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze and stretch bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.75 mL/kg bw
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights were determined before administration (day 0), weekly thereafter and on the last day of observation; clinical signs were recorded several times on the day of administration and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: skin irritation - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No systemic clinical signs observed. Local effects were not observed in males. In females, slight erythema (grade 1) was observed in all animals starting on study day 1 until day 2, 5 or 6 (1 animal each) or until day 14 (2 animals). In 4 out of 5 females
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Oral toxicity In an acute oral toxicity study comparable to OECD guideline 401 (BASF AG, 1970), Gassner rats (5/sex/dose) were exposed to dose levels of 200, 1600, 3200 or 6400 mm3/kg bw 1-(2-hydroxyethyl)-2-pyrrolidone by gavage and observed for 14 days. The only clinical findings reported included restlessness and dyspnea at the two highest dose levels tested. No mortality was observed at any dose level and necropsy of the sacrificed animals was without findings. The LD50 was determined to be > 6400 mm3/kg bw (> 7300 mg/kg bw) for both sexes.
Inhalation toxicity In an acute inhalation toxicity study, according to the BASF-internal standard (a protocol comparable to OECD guideline 403) in which rats (n=12/sex) were exposed to a saturated vapour of the substance at 20 ºC for 8 hours, no deaths were observed during a 7 days observation period (BASF AG, 1970). Due to the low vapour pressure, the technically highest attainable concentration is approximately 0.008 mg/L when the test substance is evaporated at 20°C (concentration not determined), which is below cut off values for classification / any limit concentration.
Dermal toxicity In an acute dermal toxicity study (Limit Test) in accordance with OECD Guideline 402 and under GLP, young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item N-(2-Hydroxyethyl)-2-pyrrolidon on the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours (Bioassay, 2012). The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality occurred at the tested concentrations therefore the LD50 was determined to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
Based on the result of the available acute oral and dermal toxicity studies, 1-(2-hydroxyethyl)-2-pyrrolidone does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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