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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 212-828-1 | CAS number: 872-50-4
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.4 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 360 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 180 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEC has to be corrected for the differences in respiratory volume of animal and worker (6.7/10) and for the duration of daily exposure (6/8) of workers according to 'Reach guidance on information requirements and chemical safety assessment, Chapter R.8, November 2012'.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation is required for developmental toxicity as increasing exposure duration does not increase the incidence or severity of adverse effects.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The AF has already been handled within the correction of the modification of the dose descriptor.
Therefore, no additional factor has to be applied. - AF for other interspecies differences:
- 2.5
- Justification:
- The default AF for other interspecies differences, i.e. toxicokinetic/-dynamic differences is used.
- AF for intraspecies differences:
- 5
- Justification:
- The default factor of 5 for workers is set in line with the REACH guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 40 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: The health-based occupational exposure limit (OEL, 8-hour TWA) provided in: "Recommendation from the Scientific Committee on Occupational Exposure Limits for N-Methyl-2 -Pyrrolidone" (SCOEL, 2007) is used as worker DNEL for long-term inhalation exposure.
- Overall assessment factor (AF):
- 2
- Dose descriptor:
- NOAEC
- Value:
- 80 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2
- Justification:
- SCOEL describes an AF of 2 as adequate to account for identified and remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.8 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 237 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 237 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation is necessary since a developmental toxicity study via dermal route is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation is required for developmental toxicity as increasing exposure duration does not increase the incidence or severity of adverse effects.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The default AF for other interspecies differences, i.e. toxicokinetic/-dynamic differences is used.
- AF for intraspecies differences:
- 5
- Justification:
- The default factor of 5 for workers is set in line with the REACH guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Acute/short-term and long-term exposure - systemic effects
NMP has a low acute toxicity by all relevant routes of exposure as
indicated by the LD50/LC50 values of 4150 mg/kg bw, > 5000 mg/kg bw and
> 5100 mg/m³ determined in rats for oral, dermal and inhalation
exposure, respectively. Therefore, NMP is not subject to classification
and labelling.
Inhalation exposure:
The RAC value of 14.4 mg/m³ is considered to represent the appropriate worker DNEL (long-term inhalation exposure).
NMP is considered to be an inducer of developmental toxicity / teratogenicity (Category 1B, H361).
There are no relevant effects/hazards reported for an acute/short-term inhalation exposure.
Dermal exposure:
The RAC value of 4.8 mg/kg is considered to represent the appropriate worker DNEL (systemic effects from combined exposure).
Apart from accident reports under occupational conditions, there are no relevant effects/hazards reported for an acute/short-term dermal exposure.
NMP is considered to be an inducer of developmental toxicity / teratogenicity (Category 1B, H361).
Acute/short-term and long-term exposure -
local effects
Inhalation exposure:
The SCOEL 8 -hour TWA value of 40 mg/m³ (10 ppm) is considered to represent the appropriate worker DNEL (long-term inhalation exposure).
[For comparison: Considering the NOAEC from
the key repeated dose inhalation toxicity study (BASF SE, 1994) in the
rat as relevant dose descriptor and taking the starting point
modification and assessment factors into account, the worker DNEL can be
calculated as follows:
Relevant dose descriptor (NOAEC): 125 ppm (0.5 mg/L/ 500 mg/m3)
Modification of the starting point factor (to light work): not necessary
as a dose response is not considered for the effect
Exposure duration factor (sub-chronic to chronic): 2
Interspecies factor (rat-to-worker): 5
Intraspecies factor (no toxicokinetic/-dynamic differences expected due
to local irritational effects): 1
Extrapolation factor (NOAEC): 1
Quality of database factor: 1
worker DNEL (long-term inhalation exposure) = 500 mg/m3 /(2 × 5) = 50
mg/m3 (12 ppm)]
The SCOEL STEL value of 80 mg/m³ (20 ppm) is considered to represent the appropriate worker DNEL (acute/short-term inhalation exposure).
Skin irritation/corrosion:
NMP is irritating to skin (Category 2,
H315). Dermal irritation is not reliably quantifiable based on the
available dataset. Accordingly, no worker DNEL for skin irritation is
derived.
Eye irritation:
NMP is a mild eye irritant (Category 2,
H319). A quantitative assessment of eye irritation is not possible
because only qualitative data from the relevant studies are available.
Respiratory irritation:
NMP is irritating to the respiratory system
(Category 3, H335). Based on the lack of dose-response information, no
DNEL is derived for this endpoint. However, the health-based
occupational exposure limits of 80 mg/m³ (20 ppm; 15-min STEL) and 40
mg/m³ (10 ppm; 8-hour TWA) provided in the "Recommendation from the
Scientific Committee on Occupational Exposure Limits for
N-Methyl-2-Pyrrolidone" (SCOEL) are considered to adequately protect
against respiratory irritation following acute / short-term and long
term exposure, respectively.
Skin sensitisation:
NMP is not considered to be a skin
sensitising substance and no DNEL for a possible skin sensitising
potential has to be established.
This is in line with ECHA guidance on information requirements and
chemical safety assessment, Chapter R.8 (2012).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.6 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 360 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 90 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEC has to be corrected for the differences of the experimental exposure conditions compared to the duration of exposure for the population:
(animal study: 6h/d, 7d/w general population: 24 h/d, 7d/w) = (6/24)*(7/7)
according to ‘Reach guidance on information requirements and chemical safety assessment, Chapter R.8, November 2012’.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation is required for developmental toxicity as increasing exposure duration does not increase the incidence or severity of adverse effects.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No route to route extrapolation is needed and the dose of the animal study is assumed to be already scaled according to the allometric principle, since ventilation rate (dose expressed as concentration: mg/m3) directly depend on the basal metabolic rate.
- AF for other interspecies differences:
- 2.5
- Justification:
- The default AF for other interspecies differences, i.e. toxicokinetic/-dynamic differences is used.
- AF for intraspecies differences:
- 10
- Justification:
- The default factor of 10 for the general population is set in line with the REACH guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.5 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Dose descriptor:
- NOAEC
- Value:
- 500 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The standard factor for local tissue damage in the respiratory tract to correct for differences in the experimental exposure duration and the duration of exposure for the population and scenario under consideration for a sub-chronic study is used.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Local effects are independent of the basal metabolic rate and allometric scaling is not applied.
- AF for other interspecies differences:
- 1
- Justification:
- It is assumed that in terms of dynamics that animals and humans will respond to the insult in the same way. The default factor for remaining uncertainties of 2.5 is reduced to 1.
- AF for intraspecies differences:
- 10
- Justification:
- The default factor of 10 for the general population is set in line with the REACH guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.4 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 237 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 237 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation is necessary since a developmental toxicity study via dermal route is available.
The pregnant animals were exposed 8 h/d, hence an assessment for experimental exposure conditions does not need to be performed.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- No time extrapolation is required for developmental toxicity as increasing exposure duration does not increase the incidence or severity of adverse effects.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The default AF for other interspecies differences, i.e. toxicokinetic/-dynamic differences is used.
- AF for intraspecies differences:
- 10
- Justification:
- The default factor of 10 for the general population is set in line with the REACH guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.85 mg/kg bw/day
- Most sensitive endpoint:
- neurotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 169 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 169 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL (and the doses fed in th study) are given as ppm/animal in the original study. The most relevant effect with a conservative NOAEL was 3000 ppm observed in male rats and calculated by the study authors to equal 169 mg/kg bw/male rat.
No route to route extrapolation is necessary since an oral feedind study is available.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The standard factor for differences in the experimental exposure duration and the duration of exposure for the population and scenario under consideration for a sub-chronic study is used.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The default AF for other interspecies differences, i.e. toxicokinetic/-dynamic differences is used.
- AF for intraspecies differences:
- 10
- Justification:
- The default factor of 10 for the general population is set in line with the REACH guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Acute/short-term and long-term exposure - systemic effects
NMP has a low acute toxicity by all relevant routes of exposure as
indicated by the LD50/LC50 values of 4150 mg/kg bw, > 5000 mg/kg bw and
> 5100 mg/m³ determined in rats for oral, dermal and inhalation
exposure, respectively. Therefore, NMP is not subject to classification
and labelling.
Acute/short-term and long-term exposure -
local effects
Inhalation exposure:
The derived DNEL for local effects after long term exposure of 4.5 mg/m3 is considered to represent the appropriate general population DNEL.
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