Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-464-4 | CAS number: 107-12-0
- 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:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 December 1981 - 23 March 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male Sprague-Dawley rats were exposed by the inhalation route (6 hours/day, 5 days/week) to the substance at target exposure levels of 60, 120 and 210 ppm for 57 exposure days and mated to untreated females to assess male fertility.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Propiononitrile
- EC Number:
- 203-464-4
- EC Name:
- Propiononitrile
- Cas Number:
- 107-12-0
- Molecular formula:
- C3H5N
- IUPAC Name:
- propanenitrile
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity: 96%
Physical state: Liquid
Specific gravity: 0.78
Colour: Dark brown
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male rats were 28 days of age at receipt with body weights (measured on 10 males) ranging from 80-103g.
Female rats were 50 days of age at receipt with body weights (measured on 15 females) ranging from 155-181g.
Animals were quarantined for 7-10 days and examined for general health status.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Details on exposure:
- Exposures were conducted in 10m3 Rochester-style stainless steel and glass inhalation chambers for 6 hours per day, five days per week.
Deviation: Due to building equipment failures, two exposure days (xposure days 33 and 43) were only about 4 hours of exposure and one exposure day (day 32) was about 5 hours duration. These exposure days were counted.
The substance vapour was generated using bubbler systems. - Details on mating procedure:
- After sufficient time on study to cover the spermatogenesis cycle of the rat (46 exoosure days, 69 on study) males were mated consecutively to three females. Mated females were sacrificed at about mid-term (gestation days 13-15) and pregnancy status and pre- and post-implantation loss were determined.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical concentrations were recorded four times per chamber per day throughout the study with the exception of exposure day 43 when the exposure was limited to 4 hours. Additional concentrations were recorded three different times during the study period from 9 specified locations in each chamber to demonstrate the uniformity of distribution of hte substance vapour.
- Duration of treatment / exposure:
- 57 days
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 60 ppm (nominal)
- Dose / conc.:
- 120 ppm (nominal)
- Dose / conc.:
- 210 ppm (nominal)
- No. of animals per sex per dose:
- 15 animals per concentration.
- Control animals:
- yes, concurrent no treatment
Examinations
- Parental animals: Observations and examinations:
- Clinical analyses, body weights, physical examinations, mortality, gross necropsy.
- Postmortem examinations (parental animals):
- The tissues and organs of the thoracic, abdominal and scrotal cavities were examined and testes, epididymides, prostate glands ad seminal vesicles were removed and preserved in 10% neutral buffered formalin.
- Reproductive indices:
- Mating indices (copulations/mating opportunities), number and percent of mated animals determined to be pregnant, live implants, resorptions, and corpora lutea per dam, Percent pre- and post-implantation loss and number of females with post-implantation loss.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- High exposure level males exhibited a number of clinical signs including hypoactivity, signs of salivation, arched back and laboured breathing.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- One male of the high exposure level group died during the study after two exposure days. On the previous day this animal exhibited laboured breathing, hypoactivity, poor control of hind limbs, difficulty in standing, body tremours and involuntary movements. The study authors cautiously attribute the death to treatment, however, no unusual findings were observed at gross necropsy and no other males died prior to scheduled sacrifice.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The high exposure level produced some reduction in body weight gain. Body weights of the high exposure level group males were lower than controls by about 6-9% during most of the exposure period. This difference remained at the end of the exposure period, but the difference was not statistically significant.
Body weights of males in the low and mid exposure groups were not signifcantly different from control groups. - Ophthalmological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Infrequent signs of eye irritation was observed in about 25% of the animals of the high exposure group.
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 60 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 160 ppm
- System:
- other: Body weight gain, signs of clinical toxicity and mortality
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Results: F1 generation
Effect levels (F1)
- Key result
- Remarks on result:
- other: There was no F1 generation because the pregnant females were termainated mid gestation so that examination of live pups was not possible. However, foetuses were normal in regards to size and pre- and post-implantation losses.
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Male rats exposed to 0, 60, 120 or 210 ppm of the substance for 6 hours/day 5 days/week for 10 weeks via inhalation. These males were then mated with untreated females. Based on an evaluation of the resulting pregnancies exposure to the substance did not affect the fertility of the male rats in this study.
- Executive summary:
Male Sprague-Dawley rats were exposed to 0, 60, 120 or 210 ppm of the substance for 6 hours/day 5 days/week via whole body inhalation exposure. After 10 weeks of exposure these males were then mated with unexposed females. Females were sacrificed at mid gestation. The number of corpora lutea, implantation sites, resorptions and live implants were determined. No mortality was observed at 60 or 120 ppm. One male died in the group of rats exposed to 210 ppm. Males in this group had a reduced body weight gain and exhibited clinical signs of toxicity. These signs included hypoactivity, laboured breathing, signs of salivation and arched backs. A few of these signs were also seen in the mid dose group but there was no effect on body weight gain. None of these observations were reported in males from the low dose group. Females that mated with males exposed to the substance produced litters that were normal in regards to size and pre- and post-implantation losses. Based on an evaluation of the resulting pregnancies exposure to the substance did not affect the fertility of the male rats in this study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.