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EC number: 221-877-8 | CAS number: 3266-23-7
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented report, comparable to guideline/standards
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- publication
- Title:
- Respiratory tract lesions in F344/N rats and B6C3F1 mice after inhalation exposure to 1,2-epoxybutane.
- Author:
- Dunnick, J.K., Eustis, S.L., Piegorsch, W., Miller, A.
- Year:
- 1 988
- Bibliographic source:
- Toxicology 50, 69 - 82
Materials and methods
- Principles of method if other than guideline:
- according to internal NTP guidelines
- GLP compliance:
- yes
- Remarks:
- testing lab.
Test material
- Reference substance name:
- 1,2-epoxybutane
- EC Number:
- 203-438-2
- EC Name:
- 1,2-epoxybutane
- Cas Number:
- 106-88-7
- Molecular formula:
- C4H8O
- IUPAC Name:
- 2-ethyloxirane
- Details on test material:
- 1,2-epoxybutane - purity > 99%; impurity: 1,2-butanediol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female rats used in this study were produced under strict barrier conditions at Charles River Breeding Laboratories under a contract to the Carcinogenesis Program. Breeding stock for the foundation colonies at the production facility originated at the National Institutes of Health Repository. Animals shipped for study were progeny of defined microflora-associated parents that were transferred from isolators to barrier-maintained rooms. Animals were shipped to the study laboratory at 4-6 weeks of age and were quarantined for 3 weeks. Thereafter, a complete necropsy was performed on five animals of each sex and species to assess their health status. The ratss were placed on study at 7-9 weeks of age.
All animals were housed individually in Hazleton chambers throughout the study. Feed and water were available ad libitum except during exposure periods; water was available at all times.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- other: room air
- Duration of treatment / exposure:
- 103 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week
- Post exposure period:
- -
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200, 400 ppm (0.598, 1.197 mg/l)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Because of the lower body weight gain and nasal cavity inflammation at 800 ppm, 1,2-epoxybutane concentrations selected for rats for the 2-year studies were 200 and 400 ppm.
Examinations
- Observations and examinations performed and frequency:
- Body weights and clinical signs, survival, nasal cavity, lung, hematopoietic system, thyroid gland, anterior pituitary gland, preputial gland.
All animals were observed two times per day, and clinical signs were recorded once per month. Individual body weights were recorded once per week for the first 13 weeks of the studies and once per month thereafter. Mean body weights were calculated for each group. Animals found moribund and those surviving to the end of the studies were humanely killed. - Sacrifice and pathology:
- A necropsy was performed on all animals including those found dead, unless they were excessively autolyzed or cannibalized, missexed, or found missing. Thus, the number of animals from which particular organs or tissues were examined microscopically varies and is not necessarily equal to the number of animals that were placed on study.
During necropsy, all organs and tissues were examined for grossly visible lesions. Tissues were preserved in 10% neutral buffered formalin, embedded in paraffin, sectioned, and stained with hematoxylin and eosin.
Necropsy and histologic examination performed on all animals; the following tissues examined: adrenal glands, brain, clitoral or preputial gland, colon, esophagus, gross lesions and tissue masses, heart, kidneys, lungs and mainstem bronchi, mammary gland, mandibular lymph nodes, nasal cavity and nasal turbinates, pancreas, parathyroids, pituitary gland, prostate, testes, epididymis or ovaries/uterus, rectum, regional lymph nodes, salivary glands, skin. small intestine, spleen, sternebrae including marrow, stomach. thymus, thyroid gland, trachea, tracheobronchial lymph nodes, and urinary bladder. - Statistics:
- Differences in survival were analyzed by life-table methods. Tumor incidence data were analyzed by survival-adjusted methods and by Fisher's exact tests and Cochran-Armitage trend tests based on the overall proportion of tumor-bearing animals. Non-neoplasatic incidence data were analyzed by Fisher's exact test.
Results and discussion
Results of examinations
- Details on results:
- Body Weights and Clinical Signs: Mean body weights of exposed and control male rats were similar until week 86; thereafter, mean body weights of high dose male rats were 4%-8% lower than those of the controls. Mean body weights of high dose female rats were 5%-10% lower than those of the controls after week 22. No compound-related clinical signs were observed in either males or females.
Survival: The survival of the low dose groups of both male (after week 101) and female (after week 90) rats was significantly lower than that of the control groups.
Nasal Cavity: Suppurative and serous inflammation, hyperplasia of the respiratory epithelium, and squamous metaplasia were observed at increased incidences in exposed male and female rats. Suppurative inflammation was characterized by the presence of neutrophils within the nasal cavity and mucosa; serous inflammation consisted of an eosinophilic protein-aceous material containing few inflammatory cells within the lumen of the nasal cavity. Other inflammatory lesions with lymphocyte and macrophage infiltrates were diagnosed as unspecified inflammation. Epithelial hyperplasia consisted of diffuse crowding of epithelial cells and increased thickness of the respiratory epithelium. In focal areas, nodular proliferation of respiratory epithelium formed glandlike structures that were diagnosed as adenomatous hyperplasia. Squamous metaplasia was a focal or multifocal lesion that occurred frequently within the respiratory epithelium, especially in the anterior section of the nasal cavity. Atrophy of the olfactory sensory epithelium was observed at increased incidences in exposed male and female rats. Hyperostosis of the nasal turbinate bone, consisting of a periosteal cell proliferation and new bone formation, was observed at increased frequency in high dose male rats. The incidence of papillary adenomas in high dose male rats was significantly greater than that in the controls. These tumors were exophytic papillary growths of a cuboidal to columnar nonciliated epithelium which were attached to the underlying mucosa by thin stalks or broad bases. There was no evidence of local invasive growth by these adenomas. Papillary adenomas were observed in two high dose female rats.
Lung: Alveolar/bronchiolar carcinomas and alveolar/bronchiolar adenomas or carcinomas (combined) in male rats occurred with significant positive trends; the incidences in the high dose group were significantly greater than those in the controls. The incidences of adenomas or carcinomas (combined) in female rats were as follows: control 2/50, low dose 0/49, high dose 1/150.
Hematopoietic System: The incidence of mononuclear cell leukemia was significantly greater by the life table test (P=0.011) in low dose (but not in high dose) male rats than that in the controls (control, 25/50; low dose, 31/50; high dose, 22/50).
Thyroid Gland: Follicular cell adenomas or carcinomas (combined) in female rats occurred with a significant positive trend by the life table test (P=0.043) but not by the incidental tumor test (the more appropriate test for analysis of these nonfatal tumors); the incidences in the dosed groups were not significantly greater than that in the controls (control, 0/45; low dose, 1/48; high dose, 3/48). Follicular cell hyperplasia was not observed in either control or high dose rats.
Anterior Pituitary Gland: Adenomas in female rats occurred with a signficant positive trend, 1 and the incidence in the high dose group was significantly greater than that in the controls. The incidences of adenomas or carcinomas (combined) are significant by the life table test but not by the incidental tumor test (the latter test is considered more appropriate for analysis of nonfatal tumors).
Preputial Gland: The incidences of adenomas, carcinomas, or squamous cell carcinomas (combined) in male rats (control, 3/50; low dose, 3/50; high dose, 8/50) were marginally significant by the life table trend test (P= 0.050) but not by the incidental tumor trend test (the more appropriate test for analysis of these non-fatal tumors). The incidence in the high dose group was not signicantly greater than that in the controls.
Effect levels
open allclose all
- Dose descriptor:
- NOEC
- Effect level:
- 200 ppm
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Remarks on result:
- other: Effect type: toxicity (migrated information)
- Dose descriptor:
- LOEC
- Effect level:
- 400 ppm
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Remarks on result:
- other: Effect type: toxicity (migrated information)
Any other information on results incl. tables
Exposure-related non-neoplastic and neoplastic lesions in the nasal cavity and lung of rats exposed to 1.2-Epoxybutane for 2 years
Lesions | Incidence | |||||
Male rats | Female rats | |||||
0 ppm | 200 ppm | 400 ppm | 0 ppm | 200 ppm | 400 ppm | |
Nasal cavity | ||||||
- inflammation (unspecified) | 9 | 36 | 42 | 25 | 32 | 43 |
- serious inflammation | 2 | 28 | 36 | 0 | 18 | 31 |
- suppurative inflammation | 10 | 37 | 49 | 6 | 26 | 45 |
- hyperostosis | 0 | 2 | 11 | 0 | 2 | 16 |
- epithelial hyperplasia | 8 | 38 | 46 | 5 | 29 | 40 |
- adenomatous hyperplasia | 0 | 0 | 5 | 0 | 0 | 2 |
- squamous metaplasia | 4 | 22 | 40 | 1 | 14 | 36 |
- papillary adenoma | 0 | 0 | 7 | 0 | 0 | 2 |
Olfactory sensory epthelium | ||||||
- atrophy | 0 | 18 | 12 | 0 | 13 | 8 |
Lung (alveolar/bronchiolar) | ||||||
- epithelial hyperplasia | 5 | 5 | 8 | 2 | 6 | 7 |
- adenoma | 0 | 1 | 1 | 1 | 0 | 1 |
- carcinoma | 0 | 1 | 4 | 1 | 0 | 0 |
- adenoma or carcinoma | 0 | 2 | 5 | 2 | 0 | 1 |
Based on 50 animals examined in each group; lung tumor rates for males at 400 ppm based on 49 animals.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the 2-year inhalation study, there was clear evidence of carcinogenic activity of the test substance for male F344/N rats, as shown by an increased incidence of papillary adenomas of the nasal cavity, alveolar/bronchiolar carcinomas, and alveolar/bronchiolar adenomas or carcinomas (combined). There was equivocal evidence of carcinogenic activity for female F344/N rats, as shown by the presence of papillary adenomas of the nasal cavity.
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