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EC number: 236-102-9 | CAS number: 13162-05-5
- 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
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:
- 1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
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:
- 1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Acute/short-term exposure:
N-Vinylformamide is harmful by ingestion (DSD: R22, EU GHS: Acute oral toxicity Cat. 4). However, this is not a relevant exposure route for workers and a DNEL has therefore not been derived.
Dermal - local and systemic effects: Not quantifiable, since no acute hazard has been identified for this route (data available).
Inhalation - local and systemic effects: Not quantifiable, since no acute hazard has been identified for this route (data available).
N-Vinylformamide may cause severe damage to the eye. However, this is no threshold effect and a DNEL is therefore not quantifiable. The wearing of tightly fitting safety goggles which is a highly accepted risk management measure is considered sufficient to ensure the safety of workers.
Long-term exposure:
Inhalation - local and systemic effects:
The DNEL for long-term exposure following vapour inhalation was derived based on the NOAEC value from a subchronic repeated dose inhalation study with rats (BASF AG, 1995). The respective NOAEC for local and systemic effects was 50 mg/m³ (= 17 ppm). Local effects at the next dose level of 250 mg/m³ (86 ppm) were some clinical irritation of the upper respiratory tract with mild changes in the nasal cavity as histopathological correlate. Regarding systemic effects at 250 mg/m³, the liver was identified as the main target organ (increased liver weights including histopathologically detectable liver changes), and the kidney also represented a target organ (increased urinary volume, decreased specific gravity of urine as well as decreased blood levels of sodium and chloride, increased absolute kidney weights in females, although without histopathological correlate).
The NOAEC of 50 mg/m³ which was taken as relevant dose descriptor for long-term toxicity had to be modified in order to get the correct starting point for DNEL derivation:
According to the Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, May 2008, Figure R.8-2, p. 27), the inhalatory rat NOAEC was converted into the NAEC corrected for human worker exposure conditions (8h exposure per day, respiratory volume adapted for a worker with light activity) by multiplying with the corresponding factors (x 0.75, x 0.67). The resulting corrected NAEC for local and systemic effects is equal to 25.1 mg/m³ (= 8.5 ppm).
Interspecies variation:
Concerning inhalation, rodents like the rat are in general more sensitive compared to human as the rat's ventilation frequency is higher. Also anatomical differences as well as air flow patterns between rodents and humans are to be taken into account (e.g. in case of effects at the olfactory epithelium, see Frederick et al. 1998, Harkema 1991). Furthermore, there is no evidence for differences in the general mode of action or kinetics of N-Vinylformamide in humans compared to rats. Thus, no allometric assessment factors were applied and the interspecies factor for remaining differences was set to be 2.5.
Intraspecies variation:
The intraspecies variation among human workers was recognised by an assessment factor of 5 by default.
Exposure duration:
An assessment factor of 2 was used for extrapolation of exposure duration from sub-chronic (90-day inhalation study) to chronic by default.
Dose-response:
An assessment factor of 1 was used by default.
Quality of whole database:
An assessment factor of 1 was used by default.
Accordingly, an overall assessment factor of 25 was calculated based on the recommendations given in the Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, May 2008, Figure R.8-6, p. 38) and based on the above mentioned arguments. Thus, the DNEL for long-term exposure was calculated as follows:
DNEL long-term exposure local and systemic = NAEC corrected / Overall AF = 25.1 mg/m³ / 25 = 1 mg/m³ (= 0.34 ppm).
Dermal - systemic effects:
The DNEL for systemic effects after long-term dermal exposure was derived based on the NOAEL value from a subchronic repeated dose inhalation study with rats (BASF AG, 1995). The respective NOAEL for local and systemic effects was 50 mg/m³ (= 17 ppm). Local effects at the next dose level of 250 mg/m³ (86 ppm) were some clinical irritation of the upper respiratory tract with mild changes in the nasal cavity as histopathological correlate. Regarding systemic effects at 250 mg/m³, the liver was identified as the main target organ (increased liver weights including histopathologically detectable liver changes), and the kidney also represented a target organ (increased urinary volume, decreased specific gravity of urine as well as decreased blood levels of sodium and chloride, increased absolute kidney weights in females, although without histopathological correlate).
The NOAEL of 50 mg/m³ which was taken as relevant dose descriptor for long-term toxicity had to be modified in order to get the correct starting point for DNEL derivation:
According to the Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, May 2008, Figure R.8-2, p. 27), the inhalatory NOAEL was converted into the dermal NOAEL by route-to-route extrapolation assuming a 100% absorption of the test substance by inhalation in rats compared to a 50% absorption of the test substance by dermal contact in humans, and a standard respiratory volume (sRV) of the rat corresponding to the daily exposure of workers (8 h/day) of 0.38 m³/kg bodyweight. The resulting corrected dermal NOAEL for systemic effects is equal to 38 mg/kg bodyweight/day.
Interspecies variation:
There is no evidence for differences in the general mode of action or kinetics of N-Vinylformamide in humans compared to rats. Thus, no allometric assessment factors were applied and the interspecies factor for remaining differences was set to be 2.5.
Intraspecies variation:
The intraspecies variation among human workers was recognised by an assessment factor of 5 by default.
Exposure duration:
An assessment factor of 2 was used for extrapolation of exposure duration from sub-chronic (90-day inhalation study) to chronic by default.
Dose-response:
An assessment factor of 1 was used by default.
Quality of whole database:
An assessment factor of 1 was used by default.
Accordingly, an overall assessment factor of 25 was calculated based on the recommendations given in the Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, May 2008, Figure R.8-6, p. 38) and based on the above mentioned arguments. Thus, the DNEL for long-term exposure was calculated as follows:
DNEL long-term exposure local and systemic = NOAEC corrected / Overall AF = 38 mg/kg bw/day / 25 = 1.52 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.178 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
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:
- 0.178 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
N-Vinylformamide is manufactured and used as a monomer in the manufacture of polymers in industrial settings only. Resulting polymer products are marketed to industrial customers only. Therefore, consumer exposure is likely to be very low (if any exposure occurs at all, consumers are exposed to trace levels of the monomer N-Vinylformamide only).
The DNEL for long-term exposure following vapour inhalation was derived based on the NOAEC value from a subchronic repeated dose study with rats (BASF AG, 1995). The respective NOAEC for local and systemic effects was 50 mg/m³ (= 17 ppm). Local effects at the next dose level of 250 mg/m³ (86 ppm) were some clinical irritation of the upper respiratory tract with mild changes in the nasal cavity as histopathological correlate. Regarding systemic effects at 250 mg/m³, the liver was identified as the main target organ (increased liver weights including histopathologically detectable liver changes), and the kidney also represented a target organ (increased urinary volume, decreased specific gravity of urine as well as decreased blood levels of sodium and chloride, increased absolute kidney weights in females, although without histopathological correlate).
The NOAEC of 50 mg/m³ which was taken as relevant dose descriptor for long-term toxicity had to be modified in order to get the correct starting point for DNEL derivation:
According to the Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, May 2008, Figure R.8-2, p. 27), the inhalatory rat NOAEC was converted into the NAEC assuming the default consumer exposure conditions of 24 hours/day, 7 days/week instead of the exposure duration in the study (6 hours/day, 5 days/week) by multiplying with the corresponding factors (x 0.25, x 0.71). The resulting corrected NAEC for local and systemic effects was equal to 8.9 mg/m³ (= 3.0 ppm).
Interspecies variation:
Concerning inhalation, rodents like the rat are in general more sensitive compared to human as the rat’s ventilation frequency is higher. Also anatomical differences as well as air flow patterns between rodents and humans are to be taken into account (e.g. in case of effects at the olfactory epithelium, see Frederick et al. 1998, Harkema 1991). Furthermore, there is no evidence for differences in the general mode of action or kinetics of N-Vinylformamide in humans compared to rats. Thus, no allometric assessment factors were applied and the interspecies factor for remaining differences was set to be 2.5.
Intraspecies variation:
The intraspecies variation among the general population was recognised by an assessment factor of 10 by default.
Exposure duration:
An assessment factor of 2 was used for extrapolation of exposure duration from sub-chronic (90-day inhalation study) to chronic by default.
Accordingly, an overall assessment factor of 20 was calculated based on the recommendations given in the Guidance on information requirements and chemical safety assessment, Chapter R.8 (ECHA, May 2008, Figure R.8-6, p. 38) and based on the above mentioned arguments:
Assessment Factor for |
Local effects |
Interspecies |
2.5 |
Intraspecies |
10 |
Exposure duration (sub-chronic to chronic) |
2 (default) |
Dose-response |
1 (default) |
Quality of whole database |
1 (default) |
Overall AF |
50 |
Thus, the DNEL for long-term exposure was calculated as follows:
DNEL long-term exposure local and systemic = NAEC corrected / Overall AF = 8.9 mg/m³ / 50 = 0.178 mg/m³ (= 0.06 ppm).
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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