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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.02.-23.06.2008.
- 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.31 (Prenatal Developmental Toxicity Study)
- 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 (outbred SPF quality)
- Details on test animals or test system and environmental conditions:
- SPF - Specified Pathogen Free
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: water for injection
- Duration of treatment / exposure:
- 7 days/ week
- Duration of test:
- 3 weeks
- No. of animals per sex per dose:
- Number of Dams Dose or Conc (mg/kg)
19 0
20 80
19 200
21 500 - Control animals:
- yes
Examinations
- Maternal examinations:
-
CLINICAL OBSERVATIONS OF FEMALES: Yes
- Time schedule: daily during the administration period.
BODY WEIGHT: Yes
- Time schedule for examinations: on the 1st, 5th, 8th, 11th, 14th, 17th and 20th day of pregnancy
FOOD CONSUMPTION:
- Food consumption was measured on 5th, 8th, 11th, 14th, 17th and 20th day of pregnancy. In the given day the remainder of pellets of each cage was weighed, the new food was weighed out and the food consumption for one female and one day was computed (average value for each cage).
MORTALITY CONTROL, HEALTH CONDITION CONTROL : yes
- Time schedule: daily during the acclimatization, mating and pregnancy period. - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: Yes: all per litter
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No death during the study.
Administration of the substance affected clinical status, macroscopic structure of organs and fetal skeleton in treated maternal animals. These
effects manifested in results of health condition controls and clinical observations (watery excrements, flabby body, secretion from nostrils and eyes, piloerrections, apathy) during maternal animal necropcies (findings in stomach and duodenum) and examinations of ossification and structure of
fetal skeleton (decreased extent of skeletal ossification, higher occurence of skeletal variance) especially at the highest dose level. Changes of
maternal anymal clinical status at the middle dose level had only mild intensity and other signifficant adverse effects were not diagnosed at maternal animals and their foetuses of this dose level. Either at the lowest dose level no adverse effects in maternal animals and foetuses were detected.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day
- Basis for effect level:
- other: other:
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Effects on foetus (gross);
No statistically significant differences were detected in comparision with control group.
During examination the symmetry of fore and hind limbs, number of fingers, closing or opening of eye fissures and external auditory canal, symmetry of head, integrity of superior palatum, status of umbilicus and genital papilla no serious alteration were often observed.
Effects on foetus (soft tissue):
No serious alterations were observed.
In foetuses of females from the lowest and the highest dose level small punctiform haemorrhages on arachnopia were sporadic.
Effects on foetus (skeletal):
During examination of foetal cranium dalayed ossification of supraoccipital bone was observed in 5 foetuses of females of the lowest dose level and in 2 foetuses of females of the highest dose level.
Incomlete ossification of sternum was recorded in foetuses of all groups. Percentual portion of foetuses with this variation was mildly increased in trated groups compared with control and this difference was dependent on dose level. The highest percentual portion of litters with affected foetuses was at the highest dose level.
Anomaly of ribs - undulation along the length of a rib was detected only in foetuses of the highest dose level. More than 30% of examined foetuses at this dose level were affected and this finding occured in more than 60% of litters.
Effect levels (fetuses)
- Dose descriptor:
- other: dose or conc
- Effect level:
- >= 80 - <= 500 mg/kg bw/day
- Basis for effect level:
- other: incomplete ossification of sternum
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Administration of the test substance affected clinical status, macroscopic structure of organs and fetal sketeton in treated maternal animals. These effects manifested in results of health condition controls and clinical observations, during maternal animal necropsies and examinations of ossification and structure of fetal skeleton especially at the highest dose level. Changes of maternal animal clinical status at the middle dose level had only mild intensity and other significant adverse effects were not diagnosed at maternal animals and their foetuses of this dose level. Either at the lowest dose level no adverse effects in maternal animals and foetuses were detected.
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