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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: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable data which meets basic scientific principles, with acceptable restrictions (purity of the test substance not specified)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Hannover rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight of males at test initiation: ca. 160 g
Mean body weight of females at test initiation: ca. 144 g - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5000, 6400, 8000, 10000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per treatment (mixed sexes)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 8 000 mg/kg bw
- Mortality:
- Mortality was 100 % at the highest tested dose of 10000 mg/kg bw, and 40 % at 8000 mg/kg bw (2 females). All animals of the 6400 and 5000 mg/kg bw groups survived. Mortalities occurred within the first 24 hours following treatment.
- Clinical signs:
- other: A series of symptoms indicative of toxicity were reported for all groups; these symptoms mainly included staggering, convulsive twitches, prone or lateral position and intermittent breathing. The surviving animals of the 8000 mg/kg bw group recovered with
- Gross pathology:
- Necropsy of the animals that died during the observation period revealed fatty liver and moldered gastro-intestinal tracts. The survivors that were sacrificed at the end of the observation period of 7 days were inconspicuous.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value was estimated on the basis of the observed mortalities and amounts to ca. 8000 mg/kg body weight.
- Executive summary:
The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401. Each test group consisting of 5 animals, i.e. 2 male and 3 female rats. Each animal received a single administration of an aqueous solution of test substance by gavage. Two concentrations of test substance in vehicle, 20 and 30 %, were used. the 20 % solution was used for the scheduled test dosages of 5000 and 6400 mg/kg bw, whereas the 30 % solution was used for the 8000 and 10000 mg/kg bw dosages. The application volume depended on the body weight of each test animal and ranged from 3.1 to 5.9 mL/animal.
The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observation period also were subjected to necropsy. The LD50 value was estimated on the basis of the observed mortalities and amounts to ca. 8000 mg/kg body weight.
CONCLUSION
The acute oral ALD50 (approximate lethal dose) of this TS was ca. 8000
mg/kg body weight.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: inhalation
- 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 with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- BASF-Test: Test was performed in principle as described in OECD Guideline 403.
The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (room temperature). 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The documentation of clinical signs was performed over a period of 7 days. - GLP compliance:
- no
- Test type:
- other: BASF Inhalation Test
- Species:
- rat
- Strain:
- other: Hannover
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight at test initiation: ca. 152 g
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: unchanged (no vehicle)
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 8 h
- Concentrations:
- saturated vapour
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- other: IRT (Inhalation Risk Test)
- Exp. duration:
- 8 h
- Remarks on result:
- other: mortality 0/6 animals
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 0.061 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 8 h
- Mortality:
- All animals survived.
- Clinical signs:
- other:
- Body weight:
- The mean body weight was ca. 152 g at test initiation, and ca. 166 g at the end of the observation period.
- Gross pathology:
- No treatment related changes observed.
- Interpretation of results:
- other: LC50 value could be established because no mortalities were occured during the test. LC0 is 0.061 mg/L (saturated atmosphere)
- Conclusions:
- nontoxic if inhaled
- Executive summary:
The sudy was performed according a standard inhalation hazard BASF Test. The principles of the performing of this test is similar with the requirements of the OECD guideline 403.
A saturated test atmosphere of test material was generated. 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The documentation of clinical signs was performed over a period of 7 days.
At this conditions 0/6 rats died after 8 h exposure (BASF AG 1961). Intermittent agitation directly after treatment ignition was the only clinical sign observed; there were no necropsy findings in the survivors after 7 d observation period. No LC50 value could be established because no mortalities were occured during the test. LC0 is 0.061 mg/L (saturated atmosphere).
The inhalation of a enriched/saturated vapor-air-mixture caused no mortality within 8 h.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable data which meets basic scientific principles, with acceptable restrictions (purity of the test substance not specified)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- BASF-Test
Two animals were treated for 20 hours with the test substance, which was applied onto the intact skin on the left side of the back; the application site covered a skin area of 2.5 cm x 2.5 cm. In addition, ear skin also was tested. The application volume was 2 mL of hygroscopic, partly diluted test material. The application site of the back was examined for skin reaction after 24, 48 and 72 hours, and after 6 and 8 days following treatment. - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Body weight at test initiation: 2.3 and 2.93 kg, respectively.
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 2 mL
- Duration of treatment / exposure:
- 20 hour(s)
- Observation period:
- 8 d
- Number of animals:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- other: scaling observed at the test end, d8
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: scaling observed on d3 and at the test end, d8
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Since the exposure to the test substance was performed for 20 h under occlusive conditions, the results has to be considered as overpredictive in comparison to results of actually recommended guideline studies (4 h exposition, semiocclusive conditions)
- Executive summary:
The study was conducted according to an internal BASF method. Two animals were treated for 20 hours with the test substance, which was applied onto the intact skin on the left side of the back; the application site covered a skin area of 2.5 cm x 2.5 cm. In addition, ear skin also was tested. The application volume was 2 mL of hygroscopic, partly diluted test material. The application site of the back was examined for skin reaction after 24, 48 and 72 hours, and after 6 and 8 days following treatment.
No edema was observed. However, erythema was observed in animal1 and animal 2. Animal 1 showed a grading of 1.3 and animal 2 presented with a grading of 0.7. The erythema was reversible within 8 days and 72 hours, respectively. Since the exposure to the test substance was performed for 20 h under occlusive conditions, the results has to be considered as overpredictive in comparison to results of actually recommended guideline studies (4 h exposition, semiocclusive conditions)
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1961
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable data which meets basic scientific principles, with acceptable restrictions (purity of the test substance not specified)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: BASF Test comparable to OECD Guideline 405
- Principles of method if other than guideline:
- BASF-Test. 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
- GLP compliance:
- no
- Remarks:
- The study was performed prior to the adoption of the GLP requirements
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Body weight at test initiation: 2.46 and 3.2 kg, respectively
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: physiological saline was applied to the left eye, which served for control
- Amount / concentration applied:
- Amount applied: 0.05 mL
- Duration of treatment / exposure:
- unspecified (eyes were not washed)
- Observation period (in vivo):
- until complete reversibility of the effects was observed: 6 d (animal 1)/7 d (animal 2)
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM: Draize (The original findings for both animals (referred to as 1 and 2) were converted into a numerical scoring system according to Draize)
TOOL USED TO ASSESS SCORE: fluorescein (at the final reading) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: based on effects in two animals
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Remarks on result:
- other: based on effects in two animals
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: based on effects in two animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Remarks on result:
- other: based on effects in two animals
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- 2-pyrrolidone is considered to be irritating to the rabbit eyes (Category II).
- Executive summary:
In a study in rabbits 2-pyrrolidone was investigated for its potential to induce eye irritation/corrosion. 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405. The test item produced in the present eye irritation test alterations at the cornea and conjunctivae. The iris was not affected. The observable effects were fully reversible until the end of the study.
Based on corneal opacity (24-72h score is 2 across 2 test animals), 2-pyrrolidone is classified for its eye irritation potential as follows: irritating to eyes Cat.2 (EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulations No. 1271/2008).
Reading | animal | cornea | iris | conjunctivae | |
No. | opacity | redness | swelling | ||
24 h | 1 | 2 | 0 | 1 | 0 |
24 h | 2 | 2 | 0 | 2 | 0 |
48 h | 1 | 2 | 0 | 1 | 0 |
48 h | 2 | 2 | 0 | 1 | 0 |
72 h | 1 | 2 | 0 | 0 | 0 |
72 h | 2 | 2 | 0 | 0 | 0 |
6 d | 1 | 0 | 0 | 0 | 0 |
6 d | 2 | 2 | 0 | 0 | 0 |
7 d | 2 | 0 | 0 | 0 | 0 |
relevant for classification: | |||||
mean | 1 | 2 | 0 | 0.7 | 0 |
24-72h | 2 | 2 | 0 | 1 | 0 |
mean | 2 | 0 | 0.8 | 0 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 961
- Report date:
- 1961
Materials and methods
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- no
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:
- Physical state: solid
Degree of Purity: no data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Tuebinger
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Strain: Tuebinger
Breeder: BASF AG
Mean body weight for the males: ca. 30 g
Mean body weight of the females: ca. 25 g
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Doses:
- 3200, 3600 and 4000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- TEST PROCEDURE
The study was conducted according to an internal BASF method. Several groups of 5-10 mice per sex and dose were treated intraperitoneally with preparations of the test substance as 20 % aqueous solution (w/v). Each of the low and the high test dose group (i.e. 3200 and 4000 mg/kg bw) consisted of 5 animals, i.e. 2 males and 3 females); the mid dose group consisted of a total of 10 animals (5/sex). Each animal received a single intraperitoneal injection of test solution and the application volume ranged between 16 and 20 mL/kg bw. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observation period also were subjected to necropsy. The LD50 value was estimated on the basis of the observed mortalities.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 800 mg/kg bw
- Mortality:
- Mortality was 100 % at the highest tested dose of 4000 mg/kg bw, and 10 % at 3600 mg/kg bw (1 female died); the animals died within the first 24 hours following treatment. No mortality was seen in the 3200 mg/kg bw group.
- Clinical signs:
- A series of symtoms indicative of toxicity were reported for all groups. These symptoms mainly included accelerated breathing, convulsion or convulsive twitches, tonic-clonic spasms, prone position and apathy; they almost were observed within the first 30 minutes following injection. The surviving animals of the 3600 and 3200 mg/kg bw group recovered within one day.
- Gross pathology:
- Necropsy of the animals that died during the observation period revealed pale liver and kidney (fatty ?). No further abnormalities were seen. The survivors that were sacrificed at the end of the observation period of 7 days were inconspicuous.
Applicant's summary and conclusion
- Executive summary:
The study was conducted according to an internal BASF method. Several groups of 5-10 mice per sex and dose were treated intraperitoneally with preparations of the test substance as 20 % aqueous solution (w/v). Each of the low and the high test dose group (i.e. 3200 and 4000 mg/kg bw) consisted of 5 animals, i.e. 2 males and 3 females); the mid dose group consisted of a total of 10 animals (5/sex). Each animal received a single intraperitoneal injection of test solution and the application volume ranged between 16 and 20 mL/kg bw. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observation period also were subjected to necropsy. The LD50 value was estimated on the basis of the observed mortalities. Mortality was 100 % at the highest tested dose of 4000 mg/kg bw, and 10 % at 3600 mg/kg bw (1 female died); the animals died within the first 24 hours following treatment. No mortality was seen in the 3200 mg/kg bw group. A series of symtoms indicative of toxicity were reported for all groups. These symptoms mainly included accelerated breathing, convulsion or convulsive twitches, tonic-clonic spasms, prone position and apathy; they almost were observed within the first 30 minutes following injection. The surviving animals of the 3600 and 3200 mg/kg bw group recovered within one day. Necropsy of the animals that died during the observation period revealed pale liver and kidney (fatty ?). No further abnormalities were seen. The survivors that were sacrificed at the end of the observation period of 7 days were inconspicuous. The lD50 value derived amounts to 3800 mg/kg bw/day.
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