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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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13.02.-05.11.2008
- 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.34 (One-Generation Reproduction Toxicity Test)
- 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
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF (Specified Pathogen Free) breeding, VELAZ s.r.o., CZ
- Age at study initiation: males 5-6 weeks, females - 9 weeks
- Diet: complete peleted diet for rats and mice in SPF breeding (ST 1 BERGMAN) was used. Diet was sterilised before used.
- Housing: animals were housed in SPF animal room in plastic cages containing sterilised clean shavings of soft wood. During mating period, one
male with two females were housed together in one cage. Mated females were individually housed in labelled cages. Offspring was kept with mother
until weaning.
- Water (e.g. ad libitum): free access to drinking water (water ad libitum). Water was sterilised before using.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 degree of Celsius
- Humidity (%): 30-70 %
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/ 12 hour dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water for injection
- Details on mating procedure:
- - M/F ratio per cage: one male with two females
- Proof of pregnancy: by prescence of spermatozoa in vaginal smear was examinated daily during mating period
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged (how): mated females were individualy housed in labelled cages. - Duration of treatment / exposure:
- Dosing regime: males 7 days/ week, females 7 days/ week
- No. of animals per sex per dose:
- No of animals (males) Dose/ conc (mg/kg)
10 0
10 30
10 60
10 120
No of animals (females) Dose/ conc (mg/kg)
22 0
22 30
22 60
22 120 - Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- The administration of the test substance negatively influenced mortality of parental females, clinical status after application of parental males and
females, microscopical structure and biomery of reproductive organs in parental females and reproductive performance males and females.
This negative influence expressed especially at the highest dose level: previous euthanasia of one moribund pregnant female, impairment of clinical status after application in males and females (watery excrements and chromodacryorhea), increased number of microscopical findings in ovaries of females (proliferetion of stroma and degenerate follicles), slight decrease of absolute and reletive weights of reproductive organs in females,
decreased ability of males to impregnate females, decreased ability of females to achieve pregnancy and decreased total number of pups. - Postmortem examinations (parental animals):
- HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Tables 12-13 were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- Yes
- Reproductive indices:
- Effects on F1 generation: Decreased number of pups in females at the highestdose could relate with negative influence of the test substance on
early prenatal dvelopment of organism in uterus. - Offspring viability indices:
- At dose level 0 mg/kg from 164 born pups, live born are 161 pups. At dose level 30 mg/kg from 200 born pups, live born are 197 pups, a dose level 60 mg/kg from 188 born pups, live born are 188 pups. At dose level 120 mg/kg from 139 born pups, live born are 137 pups.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
females, microscopical structure and biomery of reproductive organs in parental females and reproductive performance males and females.
This negative influence expressed especially at the highest dose level: previous euthanasia of one moribund pregnant female, impairment of clinical status after application in males and females (watery excrements and chromodacryorhea), increased number of microscopical findings in ovaries of females (proliferetion of stroma and degenerate follicles), slight decrease of absolute and reletive weights of reproductive organs in females,
decreased ability of males to impregnate females, decreased ability of females to achieve pregnancy and decreased total number of pups.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Details on results (F1)
are 197 pups, a dose level 60 mg/kg from 188 born pups, live born are 188 pups. At dose level 120 mg/kg from 139 born pups, live born are 137
pups.
During observation of pups (the average number of live an dead pups in litter, sex, average weight of litter and pups, postnatal development and
occurrence of pathological macroscopic findings) negative influence of the test substance treatment was not detected.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 60 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test substance administration negatively influenced mortality of parental females, clinical status after application of parental males and females, microscopical structure and biometry of reproduction organs in parental females and reproduction performance in parental males and females.
The test substance administration did not affect offspring development after parturition. But it is not possible to exclude negative influence of the test substance on early prenatal development of organism in uterus at the highest dose level (significant decrease of total number of pups at a dose level 120 mg/kg/day.
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