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EC number: 608-174-5 | CAS number: 28183-82-6
- 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:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Mice to gestation day 18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Study was performed to mainly examine developmental toxicity.
Fertility indices were examined, but dosing did not start until mating.
Data source
Reference
- Reference Type:
- publication
- Title:
- Anticonvulsant and reproductive toxicological studies of the imidazole-based histamine H3R antagonist 2-18 in mice
- Author:
- Salim M Bastaki et al
- Year:
- 2 017
- Bibliographic source:
- Dove Press, 19 January 2018 Volume 2018:12 Pages 179—194
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male and female mice were allowed to mate and following succesful mating, females were dosed by intraperitoneal injection.
Treatment continued to Gestation Day 18 and animals examined
Although primarily performed as a developmental toxicity study, the study looked at implantation rates and fertility indices - GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- Primary medical research
Test material
- Reference substance name:
- 3-(1H-imidazol-4-yl)propyl pent-4-en-1-ylcarbamate
- Molecular formula:
- C12 H19 N3 O2
- IUPAC Name:
- 3-(1H-imidazol-4-yl)propyl pent-4-en-1-ylcarbamate
impurity 1
- Specific details on test material used for the study:
- Source Department of Technology and Biotechnology of Drugs (Kraków, Poland)
Test animals
- Species:
- mouse
- Strain:
- other: TO, Harlan Research
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Group housed on a 12-h light/dark cycle.
Food and water were available ad libitum.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- other: Isotonic saline
- Details on exposure:
- Administered at a volume of 1 mL/kg
Doses per animal were 7.5, 15, 30, and 60 mg/kg - Details on mating procedure:
- Adult female mice, about 30 g in weight and about 6 weeks of age, were mated with males in the evening, and vaginal plugs identified in the following morning were taken to indicate successful mating.
Plug positive day was regarded as day 0 of gestation. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Treatment took place on days 8 and 13 with termination on Day 18
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 7.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Dose / conc.:
- 60 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Not specific; approximately 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- Yes
- Oestrous cyclicity (parental animals):
- No
- Sperm parameters (parental animals):
- No
- Litter observations:
- No (terminated before birth)
- Postmortem examinations (parental animals):
- No
- Postmortem examinations (offspring):
- No
- Reproductive indices:
- Yes (implantation sites)
- Offspring viability indices:
- No
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 60 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 60 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The study was performed on a related polyamide to those substances formed in the reaction process and provides an indicator for possible biological effects.
This type of polyamide is closely related to many types of amine / amide found naturally in plants and animals and has bio-pharmacological effect as a metabolite in normal cells.
There was no indication of reduction in viability of young mice and no evidence of resorptions following IP administration.
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