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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
Endpoint summary
Administrative data
Description of key information
Oral: BASF AG, 1998. Subchronic oral
toxicity study with 2-Pyrrolidone in Wistar rats; Administration in the
drinking water for 3 months. Report No.52S0014/92038. GLP, according to
the OECD guideline 408, rats, drinking water, 90 days, ca. 0, 37, 207,
586 and 1125 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.26 (Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Wistar rats (Chbb: THOM (SPF)) were obtained from Dr. Karl Thomae GmbH, Biberach/Riss, Germany
- Route of administration:
- oral: drinking water
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test solutions were analysed at the start and end of the study to assure that the concentrations were correct and the 4-day stability was assessed as 97 %. The mixtures were prepared at no less than 4-day intervals.
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- continuously
- Dose / conc.:
- 0 ppm
- Remarks:
- (ca. 0 mg/kg/d)
- Dose / conc.:
- 600 ppm
- Remarks:
- (ca. 37 mg/kg/d)
- Dose / conc.:
- 2 400 ppm
- Remarks:
- (ca. 207 mg/kg/d)
- Dose / conc.:
- 7 200 ppm
- Remarks:
- (ca. 586 mg/kg/d)
- Dose / conc.:
- 15 000 ppm
- Remarks:
- (ca. 1125 mg/kg/d)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: The animals’ state of health was checked each day.
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Animals were weighed weekly and given an additional comprehensive clinical examination / a thorough physical examination at each weighing.
BODY WEIGHT: Yes
- Time schedule for examinations: Animals were weighed weekly.
- The final bodyweight was recovered on day 91
FOOD CONSUMPTION: Yes
- Time schedule: Food consumption was determined weekly.
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Water consumption was determined once/week over a period of 4-days.
OPHTHALMOSCOPIC EXAMINATION: Yes / No / Not specified
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: Yes
- Time schedule for collection of blood: blood was sampled and analyzed on study day 88
- Anaesthetic used for blood collection: Yes (identity) / No / Not specified
- Animals fasted: Yes / No / Not specified
- How many animals:
- Parameters examined: "complete haematology"
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: blood was sampled and analyzed on study day 88
- Animals fasted: Yes / No / Not specified
- How many animals:
- Parameters examined.: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, serum-gammaglutamyltransferase, sodium, potassium, chloride, inorganic phosphate, calcium, urea, creatinine, glucose, total bilirubin, total protein, albumin, globulins, triglycerides, cholesterol, magnesium.
URINALYSIS: Yes
- Time schedule for collection of urine: Urine samples were taken on day 85
- Metabolism cages used for collection of urine: Yes / No / Not specified
- Animals fasted: Yes / No / Not specified
- Parameters examined.: "complete urinanalysis"
OTHER:
- necropsies were conducted over days 92 to day 95 - Sacrifice and pathology:
- At necropsy, major organs were weighed and sections were fixed for histopathology. All animals were subjected to gross-pathological assessment, followed by histopathological examination using a complete tissue list.
- Statistics:
- Means and standard deviations for the variables food consumption, body weight, body weight change, water consumption and test substance intake (except control group) were calculated for the animals of each test group. They were printed out in the summary and individual value tables, with the exception that for test substance intake and body weight change only summary tables were prepared. For the parameters food consumption, water consumption, body weight and body weight change a parametric one-way analysis of variance was done via the F-test (ANOVA). If the resulting p-values were equal to or less than 0.05, a comparison of each dose group with the control group was carried out. These comparisons were performed simultaneously via Dunnett’s test for the hypothesis of equal means. If the results of this test were significant, labels (* for p < 0.05, ** for p < 0.01) were printed together with the group means in the tables. Both tests were performed two-sided. Statistical analysis of histopathology was conduced with a proprietary computer program.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No animal died during the study and no adverse clinical signs or ophthalmoscopic findings were noted.
- Mortality:
- no mortality observed
- Description (incidence):
- No animal died during the study and no adverse clinical signs or ophthalmoscopic findings were noted.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight was impaired statistically significant in males and females of the 15000 ppm treatment and on few days also in females of the 7200 ppm treatment. On day 91, the values were 9 % (15000 ppm males and females), and 6 % (7200 ppm females) below controls, respectively. Body weight change was impaired statistically significant in males and females of the 7200 and 15000 ppm treatment. On day 91, the values were 14 % (15000 ppm males), 20 % (7200 ppm females), 7 % (7200 ppm males) and 16 % (7200 ppm males) below controls, respectively.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- FOOD and WATER CONSUMPTION
Food consumption was impaired in the high dose treatment in males (-4 to -10 %) and females (-5 to -12 %) with statistical significance on several days. In addition, water consumption was significantly impaired in the high dose treatment in males (-5 to -19 %) and females (-14 to -27 %) with statistical significance on several days.
INTAKE OF TS
The approximate, mean daily intake of test substance in mg/kg body weight for the complete administration period is 33 -42 for the 600 ppm treatment, 184-230 for the 2400 ppm treatment, 529-643 for the 7200 ppm treatment and 1062-1189 for the 15000 ppm treatment. - Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Water consumption was significantly impaired in the high dose treatment in males (-5 to -19 %) and females (-14 to -27 %) with statistical significance on several days.
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No animal died during the study and no adverse clinical signs or ophthalmoscopic findings were noted.
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Hematology: No substance-related changes were observed in the results of the hematology examinations of both sexes.
Clotting analyses: At the end of the study statistically significant prolonged prothrombin times were measured in the plasma of the high dose males. In the high dose females there was only a trend towards prolonged prothrombin times.
Enzymes: No substance-related changes were observed in the results of the serum enzyme examinations of both sexes. - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Blood chemistry: After 3 months of test substance administration statistically significant decreased total protein and globulin concentrations were found in the serum of the male and female animals of the high dose treatment. Additionally, statistically significant decreased total protein levels were detected in the females of the 7200 ppm treatment. In the high dose males, triglyceride concentrations were statistically significant increased, whereas in the high dose females this finding was seen only as a trend. Moreover, statistically significant reduced creatinine levels were found in females of the two highest dosed treatments; in the males of the two highest dosed treatments only a trend towards decreased creatinine concentrations was observed.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Increased specific gravity and reduced volume were found in the urine specimens of the male animals of the two highest dosed treatments. Furthermore, in most of the urine specimens of the males of the two highest dosed treatments a dark-yellow discoloration was noted. In the females no corresponding findings were observed.
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Relative kidney weights were increased in males and females of the 15000 ppm treatment and in males of the 7200 ppm treatment. In females of all treatments with the TS an altered cellular composition of the thymic cortex was seen.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In females of all treatments with the TS an altered cellular composition of the thymic cortex was seen.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
- Details on results:
- Mean test material consumption in mg/kg*day were: - males: 33, 184, 529 and 1062 mg/kg - females 42, 230, 643 and 1189 mglkg
MORTALITY, CLINICAL SIGNS and OPHTHALMOSCOPY
No animal died during the study and no adverse clinical signs or ophthalmoscopic findings were noted.
FOOD and WATER CONSUMPTION
Food consumption was impaired in the high dose treatment in males (-4 to -10 %) and females (-5 to -12 %) with statistical significance on several days. In addition, water consumption was significantly impaired in the high dose treatment in males (-5 to -19 %) and females (-14 to -27 %) with statistical significance on several days.
BODY WEIGHT and BODY WEIGHT GAIN
Body weight was impaired statistically significant in males and females of the 15000 ppm treatment and on few days also in females of the 7200 ppm treatment. On day 91, the values were 9 % (15000 ppm males and females), and 6 % (7200 ppm females) below controls, respectively. Body weight change was impaired statistically significant in males and females of the 7200 and 15000 ppm treatment. On day 91, the values were 14 % (15000 ppm males), 20 % (7200 ppm females), 7 % (7200 ppm males) and 16 % (7200 ppm males) below controls, respectively.
INTAKE OF TS The approximate, mean daily intake of test substance in mg/kg body weight for the complete administration period is 33 -42 for the 600 ppm treatment, 184-230 for the 2400 ppm treatment, 529-643 for the 7200 ppm treatment and 1062-1189 for the 15000 ppm treatment.
CLINICAL CHEMISTRY, HEMATOLOGY and URINALYSES
Hematology: No substance-related changes were observed in the results of the hematology examinations of both sexes.
Clotting analyses: At the end of the study statistically significant prolonged prothrombin times were measured in the plasma of the high dose males. In the high dose females there was only a trend towards prolonged prothrombin times.
Enzymes: No substance-related changes were observed in the results of the serum enzyme examinations of both sexes.
Blood chemistry: After 3 months of test substance administration statistically significant decreased total protein and globulin concentrations were found in the serum of the male and female animals of the high dose treatment. Additionally, statistically significant decreased total protein levels were detected in the females of the 7200 ppm treatment. In the high dose males, triglyceride concentrations were statistically significant increased, whereas in the high dose females this finding was seen only as a trend. Moreover, statistically significant reduced creatinine levels were found in females of the two highest dosed treatments; in the males of the two highest dosed treatments only a trend towards decreased creatinine concentrations was observed.
Urinalyses: Increased specific gravity and reduced volume were found in the urine specimens of the male animals of the two highest dosed treatments. Furthermore, in most of the urine specimens of the males of the two highest dosed treatments a dark-yellow discoloration was noted. In the females no corresponding findings were observed.
OTHER DEVIATIONS
There are some further statistically significant inter-group differences in the results of the clinical pathology testing. These deviations are marginal, sporadic or inconsistent, when compared with the other sex, or lack dosage-relationship. Accordingly, these changes are considered to be of no toxicological significance.
PATHOLOGY
Relative kidney weights were increased in males and females of the 15000 ppm treatment and in males of the 7200 ppm treatment. In females of all treatments with the TS an altered cellular composition of the thymic cortex was seen.
CONCLUSION
The kidney appears to be a target organ at dose levels of 7200 ppm (about 586 mg/kg) in the drinking water and above. The NOAEL is 2400 ppm in drinking water or about 207 mg/kg*bw*day. In all treated females an altered cellular composition of the thymic cortex was seen. This was assessed as being incidental, due to the following reasons: 1. there was no dose-response relationship 2. only females were affected 3. in randomly selected control groups of other subchronic studies the same finding was observed in several cases, also. - Dose descriptor:
- NOAEL
- Effect level:
- 207 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Effects on kidneys
- Critical effects observed:
- not specified
- Conclusions:
- The test material is of low systemic toxicity if administered in repeated manner.
- Executive summary:
2 -pyrrolidone was tested for its subchronic toxicity in a 3-month drinking water study. The study was conducted in compliance with the OECD Guideline 408 and the GLP.
The purpose of this study was an assessment of the systemic toxicity after repeated exposures to the test material. Wistar rats received 0, 37, 207, 586 and 1125 mg/kg/d 2-Pyrrolidone (corresponding to 600, 2400, 7200 and 15000 ppm) in the drinking water, respectively during 90 days.
All animals were subjected daily to clinical examinations. Food consumption, water consumption and body weight were determined each week. Urinalysis, clinicochemical and hematological examinations were carried out towards the end of the administration period. All animals were subjected to gross-pathological assessment, followed by histopathological examination.
No substance related effects were seen in the two lowest dose groups. In the mid-dose group all parameters checked were slightly adverse. In the high dose group, effects were dose-dependently more severe. The kidneys were the most affected organs.
Due to adverse effects on the renal system, the NOAEL is considered to be 207 mg/kg b.w. for male and female rats.
Reference
Mean test material consumption in mg/kg*day
were:
- males: 33, 184, 529 and 1062 mg/kg
- females 42, 230, 643 and 1189 mglkg
MORTALITY, CLINICAL SIGNS and OPHTHALMOSCOPY
No animal died during the study and no adverse clinical signs or
ophthalmoscopic findings were noted.
FOOD and WATER CONSUMPTION
Food consumption was impaired in the high dose treatment in males (-4 to
-10 %) and females (-5 to -12 %) with statistical significance on
several days. In addition, water consumption was significantly impaired
in the high dose treatment in males (-5 to -19 %) and females (-14 to
-27 %) with statistical significance on several days.
BODY WEIGHT and BODY WEIGHT GAIN
Body weight was impaired statistically significant in males and females
of the 15000 ppm treatment and on few days also in females of the 7200
ppm treatment. On day 91, the values were 9 % (15000 ppm males and
females), and 6 % (7200 ppm females) below controls, respectively.
Body weight change was impaired statistically significant in males and
females of the 7200 and 15000 ppm treatment. On day 91, the values were
14 % (15000 ppm males), 20 % (7200 ppm females), 7 % (7200 ppm males)
and 16 % (7200 ppm males) below controls, respectively.
INTAKE OF TS
The approximate, mean daily intake of test substance in mg/kg body
weight for the complete administration period is 33 -42 for the 600 ppm
treatment, 184-230 for the 2400 ppm treatment, 529-643 for the 7200 ppm
treatment and 1062-1189 for the 15000 ppm treatment.
CLINICAL CHEMISTRY, HEMATOLOGY and URINALYSES
Hematology: No substance-related changes were observed in the results of
the hematology examinations of both sexes.
Clotting analyses: At the end of the study statistically significant
prolonged prothrombin times were measured in the plasma of the high dose
males. In the high dose females there was only a trend towards prolonged
prothrombin times.
Enzymes: No substance-related changes were observed in the results of
the serum enzyme examinations of both sexes.
Blood chemistry: After 3 months of test substance administration
statistically significant decreased total protein and globulin
concentrations were found in the serum of the male and female animals of
the high dose treatment.
Additionally, statistically significant decreased total protein levels
were detected in the females of the 7200 ppm treatment. In the high dose
males, triglyceride concentrations were statistically significant
increased, whereas in the high dose females this finding was seen only
as a trend. Moreover, statistically significant reduced creatinine
levels were found in females of the two highest dosed treatments; in the
males of the two highest dosed treatments only a trend towards decreased
creatinine concentrations was observed.
Urinalyses: Increased specific gravity and reduced volume were found in
the urine specimens of the male animals of the two highest dosed
treatments. Furthermore, in most of the urine specimens of the males of
the two highest dosed treatments a dark-yellow discoloration was noted.
In the females no corresponding findings were observed.
OTHER DEVIATIONS
There are some further statistically significant inter-group differences
in the results of the clinical pathology testing. These deviations are
marginal, sporadic or inconsistent, when compared with the other sex, or
lack dosage-relationship. Accordingly, these changes are considered to
be of no toxicological significance.
PATHOLOGY
Relative kidney weights were increased in males and females of the 15000
ppm treatment and in males of the 7200 ppm treatment. In females of all
treatments with the TS an altered cellular composition of the thymic
cortex was seen.
CONCLUSION
The kidney appears to be a target organ at dose levels of 7200 ppm
(about 586 mg/kg) in the drinking water and above. The NOAEL is 2400 ppm
in drinking water or about 207 mg/kg*bw*day.
In all treated females an altered cellular composition of the thymic
cortex was seen. This was assessed as being incidental, due to the
following reasons:
1. there was no dose-response relationship
2. only females were affected
3. in randomly selected control groups of other subchronic studies the
same finding was observed in several cases, also.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 207 mg/kg bw/day
- Study duration:
- subchronic
- Experimental exposure time per week (hours/week):
- 168
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity:oral
A 90 day sub-chronic study was conducted according to the GLP requirements with Wistar rats which received 0, 37, 207, 586 and 1125 mg/kg/d 2-Pyrrolidone (corresponding to 600, 2400, 7200 and 15000 ppm) in the drinking water, respectively (BASF AG, 1998). Food consumption, water consumption and body weight were determined each week. The animal’s state of health was checked each day. When the animals were weighed they were subjected to an additional comprehensive clinical examination. Ophthalmological examinations were carried out in the animals of the control group and highest dose group prior to the start and towards the end of the administration period. Urinalysis, clinicochemical and haematological examinations were carried out towards the end of the administration period. All animals were subjected to gross-pathological assessment, followed by histopathological examination.
No substance related effects were seen in the two lowest dose groups. In the 586 mg/kg treatment, slight decrease of food consumption in female animals, slight decrease of water consumption in both sexes, slightly decreased body weights in females, resulting in reduced values of 6 % an day 91, decreased body weight changes resulting in reduced values of 7 % (males) and 16 % (females) an day 91, decrease in creatinine in both sexes, decrease in total protein in the females, increased urinary specific gravity in the males, reduced urinary volume in the males, dark yellow discoloration of urine specimens in the males and increase in the mean relative kidney weights in males were observed. In the high dose group, effects were dose-dependently more severe (decreased food and water consumption in both sexes, decreased body weights resulting in reduced values of 9 % (males) and 8 % (females) on day 91, decreased body weight changes resulting in reduced values of 14 % (males) and 20 % (females) on day 91, prolonged prothrombin times in both sexes, decrease in total protein, globulins, triglycerides and creatinine in both sexes, increased urinary specific gravity in the males, reduced urinary volume in the males, dark yellow discoloration of urine specimens in the males and increase in the mean relative kidney weights in males and females).
Due to adverse effects on the renal system, the NOAEL is considered to be 207 mg/kg b.w. for male and female rats.
In this study, an altered cellular composition of the thymic cortex was seen in females of all treatment groups. This was assessed as being incidental, due to the following reasons: there was no dose-response relationship, only females were affected and in randomly selected control groups of other subchronic studies the same finding was observed in several cases, also.
Another GLP conform subchronic drinking water study was performed with only female Wistar rats to clarify this thymus findings (BASF AG 1998 b). Here, 5 females received 0, 5 and 1339 mg/kg b.w., respectively (corresponding to 0, 50, 15000 ppm) for 90 days, satellite groups of the control and the high dose group recovered for additional 28 days. Results indicate that the formerly described thymic alterations were not test substance-related. The oestrous cycle determinations and haematological examinations did not reveal a hormonal or immunotoxic potential of the test substance. Deviations in the weight parameters were regarded as incidental.
Justification for classification or non-classification
Classification is not warranted according to the criteria of EU Classification, Labelling 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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