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EC number: 201-182-6 | CAS number: 79-16-3
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Only abstract available, no detailed documentation. Further restrictions: 15 rats per group at termination (20 recommended); no ophthalmological examination; no functional observations; dose-response data not clearly reported for all parameters.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Support: Letter from Dow Corning Corp to USEPA regarding studies or reports on N-Methyl Acetamide with Attachments, date 01/03/97
- Author:
- DOW Corning Corp.
- Year:
- 1 997
- Bibliographic source:
- NTIS/OTS 0537230-1
- Reference Type:
- publication
- Title:
- Letter submitting information on a ninety-day water feeding study with N-methylacetamide on rats
- Author:
- DOW Corning Corp.
- Year:
- 1 992
- Bibliographic source:
- NTIS/OTS 0537230
- Reference Type:
- publication
- Title:
- Letter from Dow Corning Corp. to US EPA submitting results of 90-day water feeding study with N-methylacetamide
- Author:
- DOW Corning Corp.
- Year:
- 1 990
- Bibliographic source:
- NTIS/OTS 0530468
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- N-methylacetamide
- EC Number:
- 201-182-6
- EC Name:
- N-methylacetamide
- Cas Number:
- 79-16-3
- Molecular formula:
- C3H7NO
- IUPAC Name:
- N-methylacetamide
- Details on test material:
- no details
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no details
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on oral exposure:
- Test substance in water to produce a nominal exposure of 0, 50, 400, or 1000 mg/kg bw/day;
no further details - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily ad libitum
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 400 or 1000 mg/kg bw/day
Basis:
nominal in water
- No. of animals per sex per dose:
- Initial: 20
30 days after initiation 5 rats per sex per dose were sacrificed for blood collection and analysis.
At termination: 15 - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: a satellite group (n=15 per sex) was started at the high dose level but no data were reported in the result section except mortality data.
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- Body weight, food consumption, water consumption, and clinical observations throughout the study (no further details).
At termination "clinical pathology" was made (presumably hematology and clinical chemistry; no details). - Sacrifice and pathology:
- At the termination of the study after 90 days, complete gross necropsy & histopathological evaluations.
No further details. - Other examinations:
- no
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 1000 mg/kg bw/day: in males and females increased mortality (50%)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: in males and females significantly reduced body weights
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: significantly reduced food consumption
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: in males and females significantly reduced water consumption.
400 mg/kg bw/day: in females significantly reduced water consumption. - Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- >=50 mg/kg bw/day: absolute and/or relative organ weights were significantly different compared to control for spleen, kidneys, adrenals, brain, testes, and liver (no details, especially on dose-response relationship).
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- >= 50 mg/kg bw/day: in males dose dependent tubular nephrosis (minimal at low dose levels)
1000 mg/kg bw/day: in females tubular nephrosis; in males and females the liver, bone marrow, lymph nodes, thymus, eyes and Harderian glands with histological changes (hypoplasia in bone marrow, lymph nodes and thymus; no further details); eye lesions considered to be related to an inflammatory condition observed in the Harderian glands. Hepatic changes are non-specific and composed of a variety of diagnoses. Many males of the high dose group had epididymal aspermia, seminiferous tubule atrophy, and reduced seminal vesicle secretory activity. No effects reported at lower dose levels. - Histopathological findings: neoplastic:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Dose descriptor:
- LOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: tubular nephrosis (toxicological relevance at this dose unclear)
- Dose descriptor:
- LOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: effects on organ weights; not clearly stated
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Clearly toxic effects in a subchronic drinking water study in rats at 1000 mg/kg bw; in males tubular nephrosis at >= 50 mg/kg bw/day but the toxicological relevance is unclear.
- Executive summary:
Comparable to guideline study with acceptable restrictions (only abstract available, no detailed documentation but sufficient for evaluation). Further restrictions: 15 rats per group at termination (20 recommended); no ophthalmological examination; no functional observations; dose-response data not clearly reported for all parameters.
In a drinking water study 20 rats per dose per sex were exposed to 0, 50, 400, 1000 mg/kg bw/day (nominal) for 90 days. After 30 days a subgroup of 5 rats per dose per sex were sacrificed for blood analysis. At 1000 mg/kg bw/day males and females revealed increased mortality (50%), significantly reduced body weights and significantly reduced food and water consumption; in females at 400 mg/kg bw/day also significantly reduced water consumption was measured. At >= 50 mg/kg bw/day absolute and/or relative organ weights were significantly different compared to control for spleen, kidneys, adrenals, brain, testes, and liver (no details, especially on dose-response relationship). Histopathology: at >= 50 mg/kg bw/day dose dependent tubular nephrosis (minimal at low dose levels) in males was found and at 1000 mg/kg bw/day also in females. At 1000 mg/kg bw/day the liver, bone marrow, lymph nodes, thymus, eyes and Harderian glands revealed in males and females histological changes (hypoplasia in bone marrow, lymph nodes and thymus; no further details); eye lesions considered to be related to an inflammatory condition observed in the Harderian glands. Hepatic changes are non-specific and composed of a variety of diagnoses. In males reproductive organs were affected at 1000 mg/kg bw/day: epididymal aspermia, seminiferous tubule atrophy, and reduced seminal vesicle secretory activity.
Conclusion: Clearly toxic effects in a subchronic drinking water study in rats at 1000 mg/kg bw; in males tubular nephrosis at >= 50 mg/kg bw/day but the toxicological relevance is unclear.
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