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EC number: 463-070-5 | CAS number: 106966-25-0
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.10.2007.- 23.04.2008.
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 463-070-5
- EC Name:
- -
- Cas Number:
- 106966-25-0
- Molecular formula:
- C7H17N2O2Br
- IUPAC Name:
- 2-(3-methoxy-3-oxopropyl)-1,1,1-trimethylhydrazinium bromide
Constituent 1
Test animals
- Species:
- other: Albino laboratory rat
- Strain:
- other: Wistar Han
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water for injection
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- All the time
- No. of animals per sex per dose:
- Number of animals (male) Dose (mg/kg) or concentration (mg/l)
5 0
5 50
5 150
5 300
5 0
5 300
Number of animals (female) Dose (mg/kg) or concentration (mg/l)
5 0
5 50
5 150
5 300
5 0
5 300
Examinations
- Observations and examinations performed and frequency:
- MORTALITY
No mortality occured during the study.
CLINICAL SIGNS
The negative effect of the test substance on clinical status
of animals was recorded at all dose levels. Soft stool or diarrhoea, chromodacryorrhea (it means excessive outpouring of the red secretion of the Harderian gland which may be provoked by non-specific stimuli such as stress) and flabby body were observed and frequency of incidence of these symptoms was dependent on dose level (occurence at the middle and the lowest dose level was sporadical). After ending of application of the test substance the symptoms faded away - effect had reversible character.
FUNCTIONAL OBSERVATIONAL BATTEARY
No important differences were recorded during functional observation of treated and control animals.
FOOD CONSUMPTION
No significant effects on food consumption were noted.
BODY WEIGHT
Growth of animals (body weight, weigh increments, food conversion) was not changed seriously.
WATER CONSUMPTION
The water consumption of males at the dose level 300 mg/kg/day was markedly increased compared to control - this effect was reversible. The water consumption of males of the lowest and the middle dose level was similar to control males.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Administration of the test substance 3-(2,2,2-Trimethylhydrazine)methylpropionate bromide had negative effect especially on clinical status of animals, metabolism of water and ions and probably it affected the function of liver. These effects demonstrated in results of clinical observations (soft stool or diarrhea, chromodacryorrhea, flabby body, slightly decreased activity), biochemical examination of blood (hyperchloraemia, hyponatraemia, decreased values of liver enzymes) and urinalysis (decreased volume of urine, increased value of specific gravity, increased value of pH, proteinuria, haematuria, leucocyturia) of treated males and females and high incidence of significant or statistically significant differences was recorded at the middle and especially at the highest dose level. Changes at the lowest dose level had only mild intensity and were not considered as adverse. Effect of the test substance on growth of animals and biometry of organs was not serious. In haematological (red blood component and blood coagulation) and histopathological examination (stomach, kidney) changes were diagnosed but they were not biologically significant. No sex differences in the reaction of animals to the treatment by the test substance have been detected.
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