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EC number: 203-691-9 | CAS number: 109-65-9
- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Nanomaterial pour density
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- 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
Carcinogenicity
Administrative data
Description of key information
Carcinogenicity and chronic toxicity examined by inhalation exposure using groups of F344/DuCrlCrlj (Fischer) rats.
There was no evidence of carcinogenic activity of 1-bromobutane in male or female rats.
Carcinogenicity and chronic toxicity examined by inhalation exposure using groups of B6D2F1/Crlj mice.
There was clear evidence of carcinogenic activity of 1-bromobutane in male mice. There was no evidence of carcinogenic activity of 1-bromobutane in females.
Key value for chemical safety assessment
Carcinogenicity: via inhalation route
Link to relevant study records
- Endpoint:
- carcinogenicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is in accordance with GLP and OECD test guidelines, however, the information is not a full study report and is available in the public domain
- Remarks:
- The available report is appended below for clarity.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- No further details specified in the study report
- Species:
- rat
- Strain:
- other: F344
- Details on species / strain selection:
- Not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No further details specified in the study report.
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- Not specified
- Details on exposure:
- Stainless-steel inhalation exposure chambers (volume: 8500 L) were used throughout the 2-year exposure period. 1-Bromobutane vapor-air mixtures were generated by bubbling clean air through 1-bromobutane liquid and the mixtures supplied to the inhalation exposure chambers.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The identity of the 1-Bromobutane used in these experiments was confirmed by both infrared spectrometry and mass spectrometry, and it was analyzed by gas chromatography before and after its use to affirm its stability.
Air concentrations of 1-bromobutane vapor in the inhalation exposure chambers were monitored at 15 min intervals by gas chromatography. - Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- 6 hours/day, 5 days/week
- Post exposure period:
- Not specified
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 125 ppm (nominal)
- Dose / conc.:
- 250 ppm (nominal)
- Dose / conc.:
- 500 ppm (nominal)
- No. of animals per sex per dose:
- Each group of test animals consisted of either 50 male or 50 female rats.
Both sexes were exposed to each concentration of 1-bromobutane vapor. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- The highest dose level was chosen so as not to exceed the maximum tolerated dose (MTD), based on both growth rate and toxicity in the previous 13-week toxicity study.
- Positive control:
- Not required
- Observations and examinations performed and frequency:
- The animals were observed daily for clinical signs and mortality. Body weight and food consumption were measured once a week for the first 14 weeks and every 4 weeks thereafter.
Urinalysis was performed near the end of the exposure period. For hematology and blood biochemistry at the terminal necropsy, surviving animals were fasted overnight and bled under deep ether anesthesia. - Sacrifice and pathology:
- All animals, including those found dead or in a moribund state as well as those surviving to the end of the 2-year exposure period, underwent complete necropsy.
Organs and tissues were removed, weighed and examined for macroscopic lesions at necropsy. The organs and tissues were then fixed and embedded in paraffin. Five μm thick tissue sections were prepared and stained with hematoxylin and eosin and examined microscopically. - Statistics:
- Incidences of neoplastic lesions were statistically analyzed by Fisher’s exact test. Any positive dose-response trends of 1-Bromobutane induction of neoplastic lesions were analyzed by Peto’s test. Incidences of non-neoplastic lesions and urinalysis were analyzed by the Chi-square test. Changes in body weight, food consumption, hematological and blood biochemical parameters, and organ weights were analyzed by Dunnett’s test.
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The body weights of the highest exposure groups, 500 ppm-exposed males and females, were slightly decreased: terminal body weights of the 500 ppm-exposed males and females were suppressed to 83% and 90% of their respective controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Description (incidence and severity):
- An increase in the incidence of eosinophilic change in the respiratory epithelium in males exposed to 500 ppm 1-bromobutane and an increase in the severity of eosinophilic change in the olfactory epithelium of males exposed to 250 ppm and 500 ppm 1-bromobutane.
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
- Details on results:
- The body weights of the highest exposure groups, 500 ppm-exposed males and females, were slightly decreased: terminal body weights of the 500 ppm-exposed males and females were suppressed to 83% and 90% of their respective controls. No other significant differences in survival rate or clinical symptoms were found between the 1-bromobutane-exposed groups of either sex and their controls.
No significant increase in the incidence of neoplastic lesions was found in any of the 1-bromobutane-exposed groups of either sex compared with their controls. There was, however, an increase in the incidence of eosinophilic change in the respiratory epithelium in males exposed to 500 ppm 1-bromobutane and an increase in the severity of eosinophilic change in the olfactory epithelium of males exposed to 250 ppm and 500 ppm 1-bromobutane. - Relevance of carcinogenic effects / potential:
- There was no evidence of carcinogenic activity of 1-bromobutane in male or female rats.
- Key result
- Dose descriptor:
- dose level:
- Effect level:
- 500 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant effects noted in the parameters examined
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 500 ppm
- Conclusions:
- There was no evidence of carcinogenic activity of 1-bromobutane in male or female rats.
- Executive summary:
The carcinogenicity and chronic toxicity of 1-bromobutane (greater than 99.7% pure) were examined by inhalation exposure using groups of F344/DuCrlCrlj (Fischer) rats.
The studies were conducted in accordance with the Organisation for Economic Co-operation and Development (OECD) Good Laboratory Practice and with reference to the OECD Guideline for Testing of Chemicals 451 “Carcinogenicity Studies”.
Each group of test animals consisted of either 50 male or 50 female rats. Test animals were exposed to 1-bromobutane vapor at target concentrations of 0 (clean air), 125, 250 or 500 ppm (v/v) for 6 hours/day, 5 days/week for 2 years (104 weeks). Both sexes were exposed to each concentration of 1-bromobutane vapor.
Stainless-steel inhalation exposure chambers (volume: 8500 L) were used throughout the 2-year exposure period. 1-Bromobutane vapor-air mixtures were generated by bubbling clean air through 1-bromobutane liquid and the mixtures supplied to the inhalation exposure chambers. Air concentrations of 1-bromobutane vapor in the inhalation exposure chambers were monitored at 15 min intervals by gas chromatography.
The animals were observed daily for clinical signs and mortality. Body weight and food consumption were measured once a week for the first 14 weeks and every 4 weeks thereafter.
All animals, including those found dead or in a moribund state as well as those surviving to the end of the 2-year exposure period, underwent complete necropsy. Urinalysis was performed near the end of the exposure period. For hematology and blood biochemistry at the terminal necropsy, surviving animals were fasted overnight and bled under deep ether anesthesia. Organs and tissues were removed, weighed and examined for macroscopic lesions at necropsy. The organs and tissues were then fixed and embedded in paraffin. Five μm thick tissue sections were prepared and stained with hematoxylin and eosin and examined microscopically.
Results
The body weights of the highest exposure groups, 500 ppm-exposed males and females, were slightly decreased: terminal body weights of the 500 ppm-exposed males and females were suppressed to 83% and 90% of their respective controls. No other significant differences in survival rate or clinical symptoms were found between the 1-bromobutane-exposed groups of either sex and their controls.
No significant increase in the incidence of neoplastic lesions was found in any of the 1-bromobutane-exposed groups of either sex compared with their controls. There was, however, an increase in the incidence of eosinophilic change in the respiratory epithelium in males exposed to 500 ppm 1-bromobutane and an increase in the severity of eosinophilic change in the olfactory epithelium of males exposed to 250 ppm and 500 ppm 1-bromobutane.
Conclusions
There was no evidence of carcinogenic activity of 1-bromobutane in male or female rats.
- Endpoint:
- carcinogenicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is in accordance with GLP and OECD test guidelines, however, the information is not a full study report and is available in the public domain
- Remarks:
- The available report is appended below for clarity.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- not specified
- GLP compliance:
- yes
- Specific details on test material used for the study:
- No further details specified in the study report
- Species:
- mouse
- Strain:
- other: B6D2F1/Crlj
- Details on species / strain selection:
- Not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No further details specified in the study report.
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- Not specified
- Details on exposure:
- Stainless-steel inhalation exposure chambers (volume: 3900 L) were used throughout the 2-year exposure period. 1-Bromobutane vapor-air mixtures were generated by bubbling clean air through 1-bromobutane liquid and the mixtures supplied to the inhalation exposure chambers.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The identity of the 1-Bromobutane used in these experiments was confirmed by both infrared spectrometry and mass spectrometry, and it was analyzed by gas chromatography before and after its use to affirm its stability.
Air concentrations of 1-bromobutane vapor in the inhalation exposure chambers were monitored at 15 min intervals by gas chromatography. - Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- 6 hours/day, 5 days/week
- Post exposure period:
- Not specified
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 20 ppm (nominal)
- Dose / conc.:
- 50 ppm (nominal)
- Dose / conc.:
- 125 ppm (nominal)
- No. of animals per sex per dose:
- Each group of test animals consisted of either 50 male or 50 female mice.
Both sexes were exposed to each concentration of 1-bromobutane vapor. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- The highest dose level was chosen so as not to exceed the maximum tolerated dose (MTD), based on both growth rate and toxicity in the previous 13-week toxicity study.
- Positive control:
- Not required
- Observations and examinations performed and frequency:
- The animals were observed daily for clinical signs and mortality. Body weight and food consumption were measured once a week for the first 14 weeks and every 4 weeks thereafter.
Urinalysis was performed near the end of the exposure period. For hematology and blood biochemistry at the terminal necropsy, surviving animals were fasted overnight and bled under deep ether anesthesia. - Sacrifice and pathology:
- All animals, including those found dead or in a moribund state as well as those surviving to the end of the 2-year exposure period, underwent complete necropsy.
Organs and tissues were removed, weighed and examined for macroscopic lesions at necropsy. The organs and tissues were then fixed and embedded in paraffin. Five μm thick tissue sections were prepared and stained with hematoxylin and eosin and examined microscopically. - Statistics:
- Incidences of neoplastic lesions were statistically analyzed by Fisher’s exact test. Any positive dose-response trends of 1-Bromobutane induction of neoplastic lesions were analyzed by Peto’s test. Incidences of non-neoplastic lesions and urinalysis were analyzed by the Chi-square test. Changes in body weight, food consumption, hematological and blood biochemical parameters, and organ weights were analyzed by Dunnett’s test.
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- The incidence of bronchiolar-alveolar carcinomas in the lung was increased in males exposed to 50 ppm and 125 ppm 1-bromobutane. No significant increases in the incidence of neoplastic lesions was found in any of the 1-bromobutane-exposed female groups. There was, however, an increase in the incidence of eosinophilic change in the olfactory epithelium of females exposed to 125 ppm 1-bromobutane.
- Other effects:
- not specified
- Relevance of carcinogenic effects / potential:
- There was clear evidence of carcinogenic activity of 1-bromobutane in male mice. There was no evidence of carcinogenic activity of 1-bromobutane in females.
- Key result
- Dose descriptor:
- dose level:
- Effect level:
- 50 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: neoplastic
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 50 ppm
- System:
- respiratory system: lower respiratory tract
- Organ:
- alveoli
- bronchi
- lungs
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- There was clear evidence of carcinogenic activity of 1-bromobutane in male mice. There was no evidence of carcinogenic activity of 1-bromobutane in females.
- Executive summary:
The carcinogenicity and chronic toxicity of 1-bromobutane (greater than 99.7% pure) were examined by inhalation exposure using groups of B6D2F1/Crlj mice.
The studies were conducted in accordance with the Organisation for Economic Co-operation and Development (OECD) Good Laboratory Practice and with reference to the OECD Guideline for Testing of Chemicals 451 “Carcinogenicity Studies”.
Each group of test animals consisted of either 50 male or 50 female mice. Test animals were exposed to 1-bromobutane vapor at a target concentration of 0 (clean air), 20, 50 or 125 ppm (v/v) for 6 hours/day, 5 days/week for 2 years (104 weeks). Both sexes were exposed to each concentration of 1-bromobutane vapor.
Stainless-steel inhalation exposure chambers (volume: 3900 L) were used throughout the 2-year exposure period. 1-Bromobutane vapor-air mixtures were generated by bubbling clean air through 1-bromobutane liquid and the mixtures supplied to the inhalation exposure chambers. Air concentrations of 1-bromobutane vapor in the inhalation exposure chambers were monitored at 15 min intervals by gas chromatography.
The animals were observed daily for clinical signs and mortality. Body weight and food consumption were measured once a week for the first 14 weeks and every 4 weeks thereafter.
All animals, including those found dead or in a moribund state as well as those surviving to the end of the 2-year exposure period, underwent complete necropsy. Urinalysis was performed near the end of the exposure period. For hematology and blood biochemistry at the terminal necropsy, surviving animals were fasted overnight and bled under deep ether anesthesia. Organs and tissues were removed, weighed and examined for macroscopic lesions at necropsy. The organs and tissues were then fixed and embedded in paraffin. Five μm thick tissue sections were prepared and stained with hematoxylin and eosin and examined microscopically.
Results
No significant difference in survival rate, clinical symptoms, body weight or food consumption was found between any 1-bromobutane-exposed group of either sex and their respective controls.
The incidence of bronchiolar-alveolar carcinomas in the lung was increased in males exposed to 50 ppm and 125 ppm 1-bromobutane. No significant increases in the incidence of neoplastic lesions was found in any of the 1-bromobutane-exposed female groups. There was, however, an increase in the incidence of eosinophilic change in the olfactory epithelium of females exposed to 125 ppm 1-bromobutane.
Conclusions
There was clear evidence of carcinogenic activity of 1-bromobutane in male mice. There was no evidence of carcinogenic activity of 1-bromobutane in females.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- 50 mg/m³
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- K2
- System:
- respiratory system: upper respiratory tract
- Organ:
- lungs
Justification for classification or non-classification
Additional information
Carcinogenicity and chronic toxicity of 1-bromobutane examined by inhalation exposure using groups of F344/DuCrlCrlj (Fischer) rats.
Each group of test animals consisted of either 50 male or 50 female rats. Test animals were exposed to 1-bromobutane vapor at target concentrations of 0 (clean air), 125, 250 or 500 ppm (v/v) for 6 hours/day, 5 days/week for 2 years (104 weeks). Both sexes were exposed to each concentration of 1-bromobutane vapor.
Stainless-steel inhalation exposure chambers (volume: 8500 L) were used throughout the 2-year exposure period. .
The animals were observed daily for clinical signs and mortality. Body weight and food consumption were measured once a week for the first 14 weeks and every 4 weeks thereafter.
All animals, including those found dead or in a moribund state as well as those surviving to the end of the 2-year exposure period, underwent complete necropsy. Urinalysis was performed near the end of the exposure period. For hematology and blood biochemistry at the terminal necropsy, surviving animals were fasted overnight and bled under deep ether anesthesia. Organs and tissues were removed, weighed and examined for macroscopic lesions at necropsy.
Results
The body weights of the highest exposure groups, 500 ppm-exposed males and females, were slightly decreased: terminal body weights of the 500 ppm-exposed males and females were suppressed to 83% and 90% of their respective controls. No other significant differences in survival rate or clinical symptoms were found between the 1-bromobutane-exposed groups of either sex and their controls.
No significant increase in the incidence of neoplastic lesions was found in any of the 1-bromobutane-exposed groups of either sex compared with their controls. There was, however, an increase in the incidence of eosinophilic change in the respiratory epithelium in males exposed to 500 ppm 1-bromobutane and an increase in the severity of eosinophilic change in the olfactory epithelium of males exposed to 250 ppm and 500 ppm 1-bromobutane.
Conclusions
There was no evidence of carcinogenic activity of 1-bromobutane in male or female rats.
Carcinogenicity and chronic toxicity of 1-bromobutane examined by inhalation exposure using groups of B6D2F1/Crlj mice.
Each group of test animals consisted of either 50 male or 50 female mice. Test animals were exposed to 1-bromobutane vapor at a target concentration of 0 (clean air), 20, 50 or 125 ppm (v/v) for 6 hours/day, 5 days/week for 2 years (104 weeks). Both sexes were exposed to each concentration of 1-bromobutane vapor.
Stainless-steel inhalation exposure chambers (volume: 3900 L) were used throughout the 2-year exposure period.
The animals were observed daily for clinical signs and mortality. Body weight and food consumption were measured once a week for the first 14 weeks and every 4 weeks thereafter.
All animals, including those found dead or in a moribund state as well as those surviving to the end of the 2-year exposure period, underwent complete necropsy. Urinalysis was performed near the end of the exposure period. For hematology and blood biochemistry at the terminal necropsy, surviving animals were fasted overnight and bled under deep ether anesthesia. Organs and tissues were removed, weighed and examined for macroscopic lesions at necropsy.
Results
No significant difference in survival rate, clinical symptoms, body weight or food consumption was found between any 1-bromobutane-exposed group of either sex and their respective controls.
The incidence of bronchiolar-alveolar carcinomas in the lung was increased in males exposed to 50 ppm and 125 ppm 1-bromobutane. No significant increases in the incidence of neoplastic lesions was found in any of the 1-bromobutane-exposed female groups. There was, however, an increase in the incidence of eosinophilic change in the olfactory epithelium of females exposed to 125 ppm 1-bromobutane.
Conclusions
There was clear evidence of carcinogenic activity of 1-bromobutane in male mice. There was no evidence of carcinogenic activity of 1-bromobutane in females.
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