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EC number: 209-939-2 | CAS number: 598-55-0
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to method equivalent or similar to OECD Guideline 451.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- no
Test material
- Reference substance name:
- Methyl carbamate
- EC Number:
- 209-939-2
- EC Name:
- Methyl carbamate
- Cas Number:
- 598-55-0
- Molecular formula:
- C2H5NO2
- IUPAC Name:
- methyl carbamate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Duration of treatment / exposure:
- 103 weeks
- Frequency of treatment:
- once a day (5 days per week)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100 and 200 mg/kg bw/day; additional group:0 and 400 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 50/sex for 0, 100 and 200 mg/kg bw/day
Additional group: 30/sex for 0 and 400 mg/kg bw/day. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- 50 male and female rat were given test substance at dose level of 0, 100 and 200 mg/kg bw/day by oral gavage for 103 weeks (5 days per week). Additional groups of 30 rats of each sex were administered 0 or 1,000 mg/kg bw/day of test substance. 10 animals from each group were killed at 6, 12, or 18 months so that the progression of lesions could be followed.
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Additional groups dosed 0 and 400 mg/kg bw/day
6 months: All vehicle control and dosed (400 mg/kg bw/day) rats survived.
12 months: All vehicle control male and female rats and dosed female rats survived. One of 10 dosed male rats died.
18 months: 1/10 dosed male and 8/10 dosed female and all vehicle control rats survived.
2 year study groups
Survival of dosed and vehicle control rats was similar (male: vehicle control, 19/60; low dose, 26/50; high dose, 29/50; female: 29/50; 36/50; 35/50).
BODY WEIGHT AND WEIGHT GAIN
2 year study groups:
Mean body weights of high dose (200 mg/kg bw/day) male rats were generally 5-9% lower than those of the vehicle controls after week 20. Mean body weights of high dose female rats were 5-8% lower than those of the vehicle controls after week 56.
GROSS PATHOLOGY
Additional groups dosed 0 and 400 mg/kg bw/day
6 months: Cytologic alterations and atypical proliferative changes were observed in the liver of all dosed male and female rats, and neoplastic nodules of the liver were onserved in 6/10 dosed male and 5/10 dosed female rats.
12 months: Neoplastic nodules of the liver were observed in 7/10 dosed male and 9/10 dosed female rats, and hepatocellular carcinomas were observed in 8/10 dosed male and 6/10 dosed female rats.
18 months: Hepatocellular carcinomas were observed in 9/10 dosed male and 8/10 dosed female rats
2 year study:
Chronic focal inflammation and cytologic alteration of the liver were observed at increased incidences in high dose rats of each sex. Hyperplasia of hepatocytes was observed at increased incidences in dosed male and high dose female rats. Neoplastic nodules or hepatocellular carcinomas (combined) in female rats occurred with a significant positive trend (0/50; 0/60; 6/49; P<0.01); the incidence of neoplastic nodules or hepatocellular carcinomas (combined) in high dose female rats was greater (P < 0.03) than that in the vehicle controls. lncidences of liver neoplasms in dosed male rats were not significantly increased (4/50; 0/50; 7/49). lnflammation of the harderian gland was observed at increased incidences in dosed rats (male: 4/50; 11/50; 16/50; female: 7/50; 16/50; 30/50). The lesions were considered to be chemically related. In the 2-year studies in rats, significant decreases in tumor incidences included the following: leukemia (both sexes), pituitary gland (male), adrenal gland (male) and mammary gland (female).
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Neoplastic nodules, hepatocellular carcinomas and liver neoplasms were observed in 200 mg/kg bw/day dose level
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Incidence of inflammation of the harderian gland was increased at all dose levels (male: 4/50; 11/50; 16/50; female: 7/50; 16/50; 30/50).
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Applicant's summary and conclusion
- Conclusions:
- There was clear evidence of carcinogenic activity for male and female F344/N rats given as indicated by increased incidences of hepatocellular neoplastic nodules and hepatocellular carcinomas.
- Executive summary:
A study was conducted to study the carcinogenicity effects of test substance in male and female F344/N rats by method equivalent or similar to OECD Guideline 451. Animals were given test substance at dose levels of 0, 100 and 200 mg/kg bw/day by oral gavage for 103 weeks (5 days per week). Additional groups of 30 rats of each sex were administered 0 or 400 mg/kg bw/day of test substance. 10 animals from each group were killed at 6, 12, or 18 months so that the progression of lesions could be followed. After 6 months, all animals survived. However, cytologic alterations and atypical proliferative changes were observed in the liver of all treated rats, and neoplastic nodules of the liver were observed in some treated rats. After 12 month studies, one of 10 dosed male rats died. Neoplastic nodules of the liver and hepatocellular carcinomas were observed in animals. After 18-months, 9 male and 2 female rats died in treated groups. Hepatocellular carcinomas were observed. In 2 years study, mean body weights of high dose rats (200 mg/kg bw /day) were lower than those of the vehicle controls. Chronic focal inflammation, cytologic alteration of the liver and hyperplasia of hepatocytes were observed in high dose rats. The incidence of neoplastic nodules or hepatocellular carcinomas (combined) in high dose female rats was greater than that in the vehicle controls. However, it was not significantly increased in male rats. Test substance also induced inflammation of the harderian gland in male and female rats. In the 2-year studies in rats, significant decreases in tumor incidences included the following: leukemia (both sexes), pituitary gland (male), adrenal gland (male) and mammary gland (female). Under the study conditions, there was clear evidence of carcinogenic activity for male and female F344/N rats given as indicated by increased incidences of hepatocellular neoplastic nodules and hepatocellular carcinomas (NTP, 1987).
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