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EC number: 600-775-0 | CAS number: 1067676-04-3
- 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:
- Mouse, 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 examine developmental toxicity with examination of embryos.
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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- Male and female mice were allowed to mate and following successful mating, females were dosed by intraperitoneal injection.
Treatment continued to Gestation Day 18 and animals examined
- GLP compliance:
- not specified
- Limit test:
- no
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)
This is reported as a potential drug for use in as a histamine antagonist
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.
Test animals
- Species:
- mouse
- Strain:
- other: TO, Harlan Research
- 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: Saline
- Details on exposure:
- Administered at a volume of 1 mL/kg
Doses per animal were 7.5, 15, 30, and 60 mg/kg - Analytical verification of doses or concentrations:
- not specified
- 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 - Duration of treatment / exposure:
- Treatment took place on days 8 and 13 with termination on Day 18
- Duration of test:
- To GD 18
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- 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:
- Approximately 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Yes
- Ovaries and uterine content:
- Yes
- Fetal examinations:
- Yes; full
- Statistics:
- Software package SPSS 24.0 (IBM Middle East, Dubai, UAE) was used.
All data were expressed as means ± standard error of mean
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- 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
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- Total number of embryos unchanged between groups
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- No difference between groups and controls
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Terminated before full-term
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 60 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- not examined
- Description (incidence and severity):
- Study terminated prior to birth
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- Description (incidence and severity):
- Study terminated prior to birth
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- No adverse effects
Effect levels (fetuses)
- 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
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental 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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