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EC number: 208-862-1 | CAS number: 544-16-1
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: Key study. Test method similar to OECD 401. The LD50 of the test item is 83 mg/kg body weight by oral route in the rat.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (no data on source of animals and environmental conditions; no data on observation period)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: COBS: CD, Charles River
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: average weight of 229.9 g (SD. 10.97; range 208-254)
- Fasting period before study: from afternoon preceding the day of dosing
- Housing: individually in suspended cages at 71ºF for several days.
- Diet (e.g. ad libitum): Ad libitum.
- Water (e.g. ad libitum): no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 71ºF
- Photoperiod (hrs dark / hrs light): 12h day-night cycle.
- Route of administration:
- oral: gavage
- Vehicle:
- ethanol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): 1 ml/kg bw
- Justification for choice of vehicle: Commercial products containing butyl nitrite may contain amounts of the aliphatic alcohols (e.g. butyl alcohol) from which they are synthesized and to which they degrade on standing. Butyl alcohol itself has an oral LD50 for the rat of 790 mg/kg, thus it is 17.2 times more toxic than ethanol (LDS0: 13.6 g/kg). Therefore, ethanol was used as a vehicle in order to determine the LD50 of butyl nitrite in the absence of significant vehicle effects.
- Purity: 95%
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A preliminary estimate of the LD50 was obtained by the Robbins-Monro procedure. An initial dose is given to 2 rats. If one of the two died, the dose was repeated. If both survived, the dose was increased; if both died, the dose was decreased. Eight pairs of animals were dosed in this manner, the next dose in the sequence being taken as the best estimate of the LD50. This dose was used to select three additional doses that were administered to an additional 28 rats (main study). These doses were selected to bracket the LD50, so that estimates of the slope of the function could be generated. - Doses:
- Preliminary study: initial dose of 100 mg/kg bw
Main study: 78, 88 and 100 mg/kg bw - No. of animals per sex per dose:
- Preliminary study: 2 males per dose (16 males in total)
Main study: 10, 9 and 9 males for doses of 78, 88 and 100 mg/kg bw respectively - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: not specified
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: not specified
- Other examinations performed: clinical signs - Statistics:
- Logit analysis
- Preliminary study:
- The Robbins-Monro procedure indicated the LD50 to be 80.75 mg/kg bw.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 82.99 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 79.49 - <= 86.49
- Key result
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- 76.44 mg/kg bw
- Based on:
- test mat.
- Mortality:
- the observed deaths were 1/10, 8/9 and 9/9 for de dosing levels of 78, 88 and 100 mg/kg bw respectively.
- Clinical signs:
- Death produced by butyl nitrite was preceded by a grey pallor of the extremities, labored breathing, ataxia, extensor rigidity and fasciculations. At higher doses, death occurred within 40 min; at doses very close to the LD50, death was delayed, in a few instances, to approximately three hours. If the animal recovered from this ataxic phase, survival was assured for two weeks.
- Body weight:
- changes in body weights not recorded.
- Gross pathology:
- not specified
- Interpretation of results:
- other: classified as acute toxicity cat. 3 (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The LD50 of the test item is 83 mg/kg body weight by oral route in the rat.
- Executive summary:
The acute oral toxicity of the test item was performed similarly to OECD Test Guideline 401. Male white rats (COBS : CD, Charles River) were used for this study. A preliminary estimate of LD50 was obtained by the Robbins-Monro procedure using 16 animals. Based on this result, the doses chosen for the main experiment were 78, 88 and 100 mg/kg bw administered by gavage on 10, 9 and 9 rats, respectively. The test item was dissolved in 95% ethanol which was used as vehicle due to its low toxicity. The proportions of deaths found in the main assay were 1/10, 8/9 and 9/9 for the doses of 78, 88 and 100 mg/kg bw, respectively. Deaths were preceded by a grey pallor of the extremities, labored breathing, ataxia, extensor rigidity and fasciculations. At doses of 76.44 mg kg bw and below, no fatalities were observed. The LD50 calculated by logit analyis was estimated to be 82.99 mg/kg bw (95% CL: 79.49-86.49).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 83 mg/kg bw
- Quality of whole database:
- Key study with Klimisch score = 2
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity: Key study: The acute oral toxicity of the test item was performed similarly to OECD Test Guideline 401. Male white rats (COBS : CD, Charles River) were used for this study. A preliminary estimate of LD50 was obtained by the Robbins-Monro procedure using 16 animals. Based on this result, the doses chosen for the main experiment were 78, 88 and 100 mg/kg bw administered by gavage on 10, 9 and 9 rats, respectively. The test item was dissolved in 95% ethanol which was used as vehicle due to its low toxicity. The proportions of deaths found in the main assay were 1/10, 8/9 and 9/9 for the doses of 78, 88 and 100 mg/kg bw, respectively. Deaths were preceded by a grey pallor of the extremities, labored breathing, ataxia, extensor rigidity and fasciculations. At doses of 76.44 mg kg bw and below, no fatalities were observed. The LD50 calculated by logit analyis was estimated to be 82.99 mg/kg bw (95% CL: 79.49-86.49).
Justification for classification or non-classification
Based on the available data, the substance is classified for acute toxicity cat. 3 according to CLP Regulation (EC) no. 1272/2008.
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