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EC number: 203-786-5 | CAS number: 110-63-4
Toxicological information
Repeated dose toxicity: inhalation
Currently viewing:
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-07-25 to 1983-08-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Inhalation toxicology of 1,4-butanediol
- Author:
- Kinney, L.A., Burgess, B.A., Stula, E.:F., Kennedy, G.L.
- Year:
- 1 991
- Bibliographic source:
- Inhalation Toxicology 3, 379 - 388
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Butane-1,4-diol
- EC Number:
- 203-786-5
- EC Name:
- Butane-1,4-diol
- Cas Number:
- 110-63-4
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,4-diol
- Details on test material:
- - Physical state:
- Analytical purity: 99.7%
- Impurities (identity and concentrations): 1,4-dihydroxybutane, 1,4-tetramethylene glycol, 1,4- butylene glycol, 4G.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: Mass Mean Diameter of respirable particulte (% respirable; <10µm):
- 2.8µm to 2.9µm at 0.20 mg/L concentration (97% respirable)
- 2.3µm to 2.8µm at 1.1 mg/L concentration (94 to 98% respirable)
- 3.6µm 5.1 mg/L concentration (74 to 92% respirable) - Details on inhalation exposure:
- DeVilbiss or Solosphere was used for generation of aerosols. Rats were restrained in perforated, stainless steel cylinders with conical nose pieces. Animals were exposed nose only 6 h/day, 5 days /wk for 2 weeks to design concentrations of 0.20, 1.0, or 5 mg/L of 1,4-butanediol in air. Control group was exposed simultaneously to air only.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Every 30 min samples were collected from each exposure chamber. Atmospheric concentration was determined from filter weight differential before and after sampling.
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- 6 h/day, 5 days/wk
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.20, 1.0, or 5 mg/L
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 male only
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Doses were selected based on the earlier acute LC50 study. The study was designed to determine the effects of repeated inhalation of sublethal concentrations of 1,4-butanediol.
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- Rats were weighed and observed daily throughout the exposure and recovery periods, weekends excluded.
- Sacrifice and pathology:
- 5 rats per group were sacrificed after 10th exposure, and 5 rats per group were sacrificed after recovery period of 14 days post exposure.
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Body weights, organ weights, clinical chemistry
- Statistics:
- Clinical results were statistically analyzed by one-way analysis of variance. Comparison of test rats with controls by least significant differences and Dunnett tests was considered valid only when the ratio of variance (F) indicated a significant among -to-within group variation. Significance was judged at 0.05 probability level.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- slight red nasal discharge in some animals. Effects were absent in animals allowed to recover for 14 days.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- slight red nasal discharge in some animals. Effects were absent in animals allowed to recover for 14 days.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced body weights at high dose from day 3 to 4 days post exposure
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose animals had significantly increased hematocrits and erythrocyte counts. Effects were absent in animals allowed to recover for 14 days.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose animals had significantly decreased serum cholesterol concentrations. Effects were absent in animals allowed to recover for 14 days.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose animals had decreased osmolality and pH. Not present in animals allowed to recover for 14 days.
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose animals had decreased mean heart weights. Not present in animals allowed to recover for 14 days.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- High dose animals had slight atrophy of lympoid cells in the thymus. Not present in animals allowed to recover for 14 days.
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
Some rats from all groups including control group had slight red nasal discharge during exposure. No other adverse clinical signs were seen.
BODY WEIGHT AND WEIGHT GAIN:
No treatment related effects were observed that were biologically significant for 0.2 and 1.1 mg/L.
For 5.2 mg/L group had significantly lower body weights than control.
FOOD CONSUMPTION
No data
FOOD EFFICIENCY
No data
WATER CONSUMPTION
No data
OPHTHALMOSCOPIC EXAMINATION
No data
HAEMATOLOGY
No treatment related effects were observed that were biologically significant for 0.2 and 1.1 mg/L.
For 5.2 mg/L group had significantly increased hematocrits and erythrocyte counts after 10 exposures
CLINICAL CHEMISTRY
No treatment related effects were observed that were biologically significant for 0.2 and 1.1 mg/L.
For 5.2 mg/L group had significantly decreased serum cholesterol after 10 exposures
URINALYSIS
Yes- once after 9th exposure. An overnight sample was collected to measure volume, osmololity, and pH. Presence of blood, sugar, protein, bilirubin, urobilinogen and ketone was analysed. Appearance of the specimen was recorded and sediment was examined microscopically.
NEUROBEHAVIOUR
No data
ORGAN WEIGHTS
No treatment related effects were observed that were biologically significant for 0.2 and 1.1 mg/L.
In rats exposed to 5.2 mg/L significantly decreased heart weight was observed after 10 exposures. This change was not significant on an organ-to-body weight basis. No significant organ weight changes were observed after 14 days recovery period.
GROSS PATHOLOGY
yes-No treatment related effects were observed that were biologically significant for all groups
HISTOPATHOLOGY: NON-NEOPLASTIC
yes - No treatment related effects were observed that were biologically significant for 0.2 and 1.1 mg/L.
Rats exposed to 5.2 mg/L had significantly decreased mean body weights from the third exposure day to 4 days post exposure.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
None noted.
HISTORICAL CONTROL DATA (if applicable)
OTHER FINDINGS
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOEC
- Effect level:
- 1 mg/L air
- Sex:
- male
- Basis for effect level:
- other: No treatment related effects were observed that were biologically significant.
- Key result
- Dose descriptor:
- LOEC
- Effect level:
- 5 mg/L air
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- haematology
- histopathology: non-neoplastic
- other: see 'Remark'
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No significant effects were noted for rats exposed to 0.2 and 1.0 mg/L.
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