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EC number: 200-820-0 | CAS number: 74-89-5
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The route of exposure (i.p.) is not standard. Beside that an acceptable, well-documented publication which meets basic scientific principles, test substance used is methylamine hydrochloride
Data source
Reference
- Reference Type:
- publication
- Title:
- Developmental toxicity of methylamines in mice
- Author:
- Guest, I. and Varma, D.
- Year:
- 1 991
- Bibliographic source:
- Journal of Toxicology and Environmental Health 32: 319-330
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Exploration if chronic administration of methylamines can cause reproductive toxicity using pregnant CD-1mice and mouse embryos in culture as experimental models.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Methylammonium chloride
- EC Number:
- 209-795-0
- EC Name:
- Methylammonium chloride
- Cas Number:
- 593-51-1
- Molecular formula:
- CH5N.ClH
- IUPAC Name:
- methanaminium chloride
- Details on test material:
- CAS 593-51-1 (methylamine hydrochloride), purity not specified
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, St. Constant, Quebec
- Weight at study initiation: 20-25 g
- Housing: Plexiglas cages with heat-treated wood chip bedding
- Diet (e.g. ad libitum): laboratory mouse chow pellets ad libitum
-Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25°C
- Humidity (%):50-70%
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- other: 0.9% saline
- Details on exposure:
- intraperitoneal injections, once daily between 08:00 and 09:00 a.m.
- Details on analytical verification of doses or concentrations:
- no data
- Details on mating procedure:
- mice bought already mated
- Duration of treatment / exposure:
- day 1-17 of gestation
- Frequency of treatment:
- daily
- Duration of test:
- until day 18 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 8 mg/kg bw/day (nominal)
- Remarks:
- = 0.25 mmol/kg bw
- Dose / conc.:
- 31 mg/kg bw/day (nominal)
- Remarks:
- = 1 mmol/kg bw
- Dose / conc.:
- 78 mg/kg bw/day (nominal)
- Remarks:
- = 2.5 mmol/kg bw
- Dose / conc.:
- 155 mg/kg bw/day (nominal)
- Remarks:
- = 5.0 mmol/kg bw
- No. of animals per sex per dose:
- 5 - 11
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Six to eight pregnant mice were admininstered 0, 8, 31, 78, and 155 mg/kg bw methylamine by ip injection from day 1 to 17 after mating
- Results of untreated controls of three parallel experiments (n=29) were pooled
Examinations
- Maternal examinations:
- - Maternal and fetal body weight, mortality, resorptions, litter size, and placental weight were recorded in the in-vivo part of the study
- Ovaries and uterine content:
- - Examination of uterine content: placental weight, resorptions, litter size
- Examination for obvious sign of implantations (uteri were stained in 10 % ammonium sulfide solution to identify implantation sites) - Fetal examinations:
- - Examination of fetuses: viability, body weight, visceral and skeletal examination
pubs weight for each female were calculated by dividing the sum of body weights of all live pups in a litter by the number of live pubs in the litter
mean pub weight for each treatment group was based on sum of mean pup weight for each female divided by the number of females in the group
fetuses were randomly placed either in Bouin solution for visceral examination by the freehand razor sectioning technique or in 95 % ethanol for the skeletal examination by an alizarin red S staining technique. - Statistics:
- - Statistical evaluation employed Student's t-test and Bonferroni test (multiple means)
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
- Methylamine hydrochloride did not produce maternal toxicity at concentrations up to 2.5 mmol/kg
- For evaluation the results of untreated controls of three parallel experiments (n=29) were pooled
- No dam died from methylamine hydrochloride treatment and maternal body weight development was within the range if the untreated control group
- No significant differences between control and treated animals were observed concerning fetal body weight, mortality, resorptions , litter size, or placental weight
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 155 mg/kg bw/day
- Basis for effect level:
- other: no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
- Methylamine hydrochloride did not have any significant effect on pregnancy outcome.
- Number of resorbed and dead fetuses were equally distributed across all doses of MMA hydrochloride.
- none of the amines (MMA, DMA, TMA) caused a significant increase in external, internal organ, or skeletal abnormalities.
- all three methylamines possess teratogenic potential in varying degrees.
- decrease of DNA, RNA, and protein after treatment of embryos with methylamines.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 155 mg/kg bw/day
- Basis for effect level:
- other: no effects observed
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
In vitro studies: all three methylamines produced concentration-dependent decreases in yolk-sac diameter, crown-rump length, head length, and fetal survival; developmental score and somite number also exhibited a similar concentration-dependent decrease.
The effect of all the three methylamines was more marked on the head length than on crown-rump length and yolk-sac diameter.
the external appearance of embryos was not affected by low concentrations of methylamines. At higher concentrations (> 0.5 mM), there appeared to be a dispropotionate retardation in forelimb and branchial bar development relative to the development of other organs. All embryos were dorsally convex at 1 mM MMA HCl or DMA HCl.
The development of hearts was unaffected at concentrations up to 1 mM of all 3 methylamines and neuropores closed well up to concentrations of 0.75 mM.
All three methylamines produced concentration-dependent decreases in embryo RNA, DNA and proteins; the realtive order of toxicity was the same as in vivo, namely TMA> DMA > MMA.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for maternal and developmental toxicity, including teratogenicity, was 155 mg/kg bw Methylammonium chloride based on the absence of any adverse findings at this dose.
- Executive summary:
Reproductive toxicity
In a toxicity study in mice no effect of intraperitoneal monomethylamine hydrochloride administration (from day 1 to 17 of gestation) on body weights and food consumption of the females and on organ weights were observed up to 155 mg/kg bw. From the above, it was considered that reproductive/developmental toxicity NOEL is 155 mg/kg bw/day for Methylammonium chloride for female mice.
Developmental toxicity
A study performed by Guest et al. in 1991, dealt with the investigation of maternal or fetal effects after administration of Methylammonium chloride via intraperitoneal injection. The numbers of resorbed and dead fetuses were equally distributed across all doses of Methylammonium chloride, and, therefore, are considered not to be treatment related. None of the amines (MMA, DMA, TMA) caused a significant increase in external, internal organ, or skeletal abnormalities, but all three possess a teratogenic potential in varying degrees in in vitro experiments on mouse embryos. Monomethylamine hydrochloride did not exert any fetal effects at the highest dose level tested. In vitro, all three methylamines produced concentration-dependent decreases in yolk-sac diameter, crown-rump length, head length, and fetal survival; developmental score and somite number also exhibited a similar concentration-dependent decrease. The external appearance of the embryos was not affected by low concentrations of methylamines, but at higher concentrations (> 0,5 mM), there appeared a disproportionate retardation in the forelimb and branchial bar development relative to the development of other organs. So, Methylammonium chloride inhibits the development of mouse embryos in culture.
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