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EC number: 209-795-0 | CAS number: 593-51-1
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from U.S. Environmental Protection Agency report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422 guideline (combined repeat dose study with a reproductive/developmental screen)
- Principles of method if other than guideline:
- Combined repeated dose repro-devp. Screen of Methylamine hydrochloride in rat
- GLP compliance:
- not specified
- Limit test:
- no
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:
- methanamine
- Reference substance name:
- Methylamine hydrochloride
- IUPAC Name:
- Methylamine hydrochloride
- Details on test material:
- - Name of test material: Methylamine hydrochloride
- Molecular formula: - CH5N.ClH
Molecular weight: 67.5184 g/mol
- Smiles notation: C[NH3+].[ClH-]
- InChl: 1S/CH5N.ClH/c1-2;/h2H2,1H3;1H
- Substance type: Organic
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material: Methylamine hydrochloride (MAH)
- IUPAC name: Methanaminium chloride
- Molecular formula: CH5NCl H
- Molecular weight: 67.5184 g/mole
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Sex: Male and female
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Methylamine hydrochloride was dissolved in water to give a dose of 0, 250, 500 and 1000 mg/Kg bw
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Water
- Concentration in vehicle: 0, 250, 500, or 1000 mg/kg/day
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Length of cohabitation: 2 weeks
- Duration of treatment / exposure:
- Total:110
Premating period -71 days
Mating period-14 days
Gestation period-21 days
Postpartum day -4. - Frequency of treatment:
- Daily
- Duration of test:
- 110
Doses / concentrations
- Remarks:
- 0, 250, 500 and 1000 mg/kg/day
- No. of animals per sex per dose:
- Total no of animals-96
0 mg/kg/day - 12 male and 12 female
250 mg/kg/day- 12 male and 12 female
500 mg/kg/day- 12 male and 12 female
1000 mg/kg/day- 12 male and 12 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
Examinations
- Maternal examinations:
- Body weight and food consumption, gross pathology and histopathology was observed.
- Ovaries and uterine content:
- Implantation sites and ovarian corpora lutea also examined.
- Fetal examinations:
- Pup viability, individual pup weights, litter sizes.and clinical signs were observed at birth and on lactation day 4.
- Statistics:
- No data available
- Indices:
- Mean Number of Pups/Litter and Offspring viability indices was observed on day 0 and 4 of lactation were examined.
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Body weight: Significant reductions in body weight in P1 animals were observed at 1000 mg/kg/day. Weight gain of pregnant females was less at 1000 mg /kg/day from gestational day 1 to day 7 (87.5% of control) but similar to the other groups at intervals after gestational day 7.
Food consumption: Significant reductions in food consumption were observed in P1 male and female rats.
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- effects observed, treatment-related
- Total litter losses by resorption:
- effects observed, treatment-related
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Reproductive function: estrous cycle: Significant decrease in corpora lutea counts and subsequently lower implantation site counts and litter sizes were observed at 1000 mg/kg/day treated female rat.
Reproductive performance: No effect on Number of Pups/Litter were observed in treated female rats.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- pre and post implantation loss
- other: No adverse effect
Results (fetuses)
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Viability: No effect on viability of treated pups were observed till day 4 of lactation as compared to control.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect on Number of Pups/Litter and viability
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- no
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
MATBRNAL GROUP: |
II-0 |
IV-0 |
VI-0 |
VIII-0 |
DOSAGB{MG/KG/DAY): |
0 |
250 |
500 |
1000 |
CORPORA LUTEA COUNTS |
14.8 |
14.5 |
15.1 |
11.4* |
Standard Deviation(No. in group) |
2.3(12) |
2.1(11) |
1.8 (12) |
3.3(10) |
MEAN NUMBER OF PUPS/LITTER |
|
|
|
|
Born |
12.8 |
13.2 |
13.9 |
9.8 |
Born Alive |
12.8 |
13.0 |
13.9 |
9.8 |
Day 4 |
12.8 |
12.0 |
13.9 |
9.7 |
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 500 mg/kg bw/day for P1 generation and 1000 mg/kg bw/day for F1 generation when male and female rats were treated with Methylamine hydrochloride (Methanaminium chloride) orally by gavage for 110 days.
- Executive summary:
In a repeated dose reproduction –development toxicity study, male and female rats were treated with Methylamine hydrochloride (Methanaminium chloride) in the concentration of0, 250, 500 and 1000 mg/kg/day orally by gavage in water. Test was conducted as per OECD 422. Significant decrease in body weight of P1 animals were observed at 1000 mg/kg/day. Weight gain of pregnant females was less at 1000 mg /kg/day from gestational day 1 to day 7 (87.5% of control) but similar to the other groups at intervals after gestational day 7. Significant reductions in food consumption were observed in P1 male and female rats. Similarly, significant decrease in corpora lutea counts and subsequently lower implantation site counts and litter sizes were observed at 1000 mg/kg/day treated female rat. But, No effect on Number of Pups/Litter were observed in treated female rats. In addition, No effect develpmental toxicity was observed in treated pups such as on viability till day 4 of lactation as compared to control at 250, 500 and 1000 mg/kg bw/day. Therefore, NOAEL was considered to be 500 mg/kg bw/day for P1 generation and 1000 mg/kg bw/day for F1 generation whenmale and female rats were treated withMethylaminehydrochloride (Methanaminium chloride) orally by gavage for 110 days.
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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