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EC number: 203-700-6 | CAS number: 109-74-0
- 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in a GLP facility to OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- Butyronitrile
- EC Number:
- 203-700-6
- EC Name:
- Butyronitrile
- Cas Number:
- 109-74-0
- Molecular formula:
- C4H7N
- IUPAC Name:
- butanenitrile
- Details on test material:
- Sponsor's identification : N-butyronitrile
Description : clear colourless liquid
Batch number : TXTXOL
Purity : 99.891%
Date received : 30 September 2012
Expiry date : not supplied
Storage conditions : room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Wistar (RccHan™:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study and identified by a number written on a cage card. At the start of the study the animals were
eight to twelve weeks of age. The bodyweights fell within an interval of ±20% of the mean weight of any previously dosed animals.
The animals were individually housed in suspended solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories U.K. Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the
study. The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- For the purpose of the 1110 mg/kg dose level, the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. For the purpose of the 35, 111 and 350 mg/kg dose levels, the test item was freshly prepared, as required, as a solution at the appropriate concentration in distilled water. The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration. All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time (at least 48 hours) was allowed between each individual animal to confirm the outcome of the previously dosed animals.
- Doses:
- Using information available on the test item an estimate of the LD50 value was made. This value (111 mg/kg) was entered into the AOT425 Statistical Program with the slope of the dose-response curve set to the default value (sigma = 0.5). The statistical program gave a recommended dose progression of 1.11, 3.5, 11.1, 35, 111, 350, 1110 and 2000 mg/kg.
- No. of animals per sex per dose:
- 1 Animal per dose
- Control animals:
- no
- Details on study design:
Animal Dose Level
number mg/kg
Dose vol
1
35 0
2
111 0
3
350 0
4
1110 X*
5
350 X
6
111 0
7
350 0
8
1110 X
9
350 X
10
111 0
X* = animal humanely killed, X= animal died, 0= Animal survived- Statistics:
- The oral LD50 was calculated by the maximum likelihood method. Data evaluations also included the relationship, if any, between the exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects. Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was calculated by the statistical program
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- 350 mg/kg bw
- 95% CL:
- 174.2 - 885
- Mortality:
- 2/2 mortalities at 1110 mg/kg, 2/3 at 350 mg/kg, 0/3 at 111 mg/kg and 0/1 at 35 mg/kg
- Clinical signs:
- other: Signs of systemic toxicity noted were hunched posture, lethargy, ataxia, pilo-erection, ptosis, occasional body tremors, pallor of the extremities abdominal discomfort, increased salivation and splayed gait. Additional signs of systemic toxicity noted in
- Gross pathology:
- Abnormalities noted at necropsy of animals that died or were humanely killed during the study were patchy pallor or dark liver, dark or pale kidneys and haemorrhage and epithelial sloughing of the gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The acute oral median lethal dose (LD50) and 95% confidence limits of the test item in the female Wistar strain rat were calculated to be 350 (174.2 – 885.0) mg/kg bodyweight (based on an assumed sigma of 0.5).
- Executive summary:
A total of ten female animals were dosed individually in sequence with sufficient time (at least 48 hours) between each animal, at dose levels ranging from 35 mg/kg bodyweight to 1110 mg/kg bodyweight. The test item was administered orally undiluted at a concentration of 1110 mg/kg or as a solution in distilled water at concentrations of 35, 111 or 350 mg/kg. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. One day after dosing two animals treated at a dose level of 350 mg/kg and both animals treated at a dose level of 1110 mg/kg were found dead or killed for humane reasons due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. Signs of systemic toxicity noted were hunched posture, lethargy, ataxia, pilo-erection, ptosis, occasional body tremors, pallor of the extremities abdominal discomfort, increased salivation and splayed gait. Additional signs of systemic toxicity noted in the animal treated at a dose level of 1110 mg/kg, that was humanely killed were prostration, emaciation, hypothermia, laboured respiration and decreased respiratory rate. There were no signs of systemic toxicity noted in animals treated at dose levels of 35 and 111 mg/kg or one animal treated at a dose level of 350 mg/kg. Surviving animals showed expected gains in bodyweight over the study period, except for one animal treated at a dose level of 111 mg/kg which showed expected gain in bodyweight during the first week but slight bodyweight loss during the second week. Abnormalities noted at necropsy of animals that died or were humanely killed during the study were patchy pallor or dark liver, dark or pale kidneys and haemorrhage and epithelial sloughing of the gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study. The acute oral median lethal dose (LD50) and 95% confidence limits of the test item in the female Wistar strain rat were calculated to be 350 (174.2 – 885.0) mg/kg bodyweight (based on an assumed sigma of 0.5).
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