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Diss Factsheets
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EC number: 202-849-4 | CAS number: 100-41-4
- 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
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Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: other: NTP protocol
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- Ethylbenzene
- EC Number:
- 202-849-4
- EC Name:
- Ethylbenzene
- Cas Number:
- 100-41-4
- Molecular formula:
- C8H10
- IUPAC Name:
- ethylbenzene
- Details on test material:
- as prescribed by 1.1 - 1.4
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Species/strain: Mouse BCC3F1
- Number of animals: 50M+50F/dose level
- Source: Simonsen Laboratories, Inc., Gilroy, CA
- Age at study initiation: 6 weeks at start of study
- Weight at study initiation: M 22.3-23.0 g; F 18.0-18.6 g g (Range of average weights reported for week 1)
- Housing: individually housed in stainless steel cages
- Diet: NIH-07 open formula pelleted diet (Zeigler Brothers Inc., Gardners, PA), ad libitum except during exposure
- Water: untreated course-filtered City of Chicago water, ad libitum except during exposure
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- other: air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE/CHAMBER DESCRIPTION
- Chambers: Stainless steel chambers
- Exposure apparatus: Flash evaporator units
- Chamber concentrations: Actual mean exposure concentrations achieved in the chambers throughout the study were 75.2, 248 and 748 ppm ethylbenzene.
TEST SUBSTANCE
Ethylbenzene was used from two lots: A060989 and A051890; A060989 had an overall purity > 99% and contained 62 +/- 3.1 ppm cumene; lot A051890 also had an overall purity of > 99%. Concentration of peroxide ranged from 1.12 to 10.7 ppm
TEST ATMOSPHERE
- Concentration: monitored by an automatic sampling system coupled to a gas chromatograph equipped with a flame ionization detector. Each study chamber atmosphere was analyzed hourly during the 6 hour exposure. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week
- Duration of test:
- 104 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
75 ppm (325 mg/m3)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
250 ppm (1084 mg/m3)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
750 ppm (3251 mg/m3)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 50M+50F/dose level
- Control animals:
- yes
- Details on study design:
- 50M+50F/dose level
Post exposure period:None - Statistics:
- Statistical analyses for possible dose-related effects on survival used Cox's method for testing two groups for equality and Tarone's life table test to identify dose-related trends. The incidences of neoplasms and nonneoplastic lesions were calculated as were the survival-adjusted neoplasm rate for each group and each site-specific neoplasm. The majority of the neoplasms in these studies were considered incidental to the cause of death or not rapidly lethal. Thus the primary statistical method used was logistic regression analysis, which assumed that the diagnosed neoplasm were discovered as the result of death from an unrelated cause and thus did not affect the risk of death. Neoplastic prevalence was modeled as a logistic function of chemical exposure and time. The neoplasm incidences of exposed and control groups were compared on the basis of the likelihood score test for the regression coefficient of dose. In addition to logistic regression other methods employed were the life table test appropriate for rapidly lethal neoplasms, and the Fisher exact test and the Cochran-Armitage trend test, procedures based on the overall proportion of neoplasm-bearing animals. Tests of significance included pair wise comparisons of each exposed group with controls and a test for an overall dose related trend. For the analysis of nonneoplastic lesions, the primary statistical analysis used was a logistic regression analysis in which nonneoplastic lesion prevalence was modeled as a logistic function of chemical exposure and time. Average severity values were analyzed for significance with the Mann-Whitney test.
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 750 ppm
- Sex:
- male/female
- Basis for effect level:
- other: Overall effects
Observed effects
Survival of exposed groups of male and female mice was similar to that of the chamber controls. No clinical findings were attributed to ethylbenzene exposure. Mean survival for male mice was 636 days in controls, 684, 692 and 665 days for 75, 250 and 750 ppm groups respectively. In females the mean survial was 689, 700, 701 and 692 days for 75, 250 and 750 ppm groups respectively.
BODY WEIGHTS: Mean body weights of female mice exposed to 75 ppm, were greater (about 6%) than those of the chamber controls from week 72 until the end of the study. Mean body weights of 750 ppm females were generally less than those of the chamber controls from week 24 through week 68 but were similar to those of the chamber control from week 72 until the end of the study. Mean body weights of male mice were similar to controls throughout the study
CLINICAL FINDINGS: No clinical findings were attributed to ethylbenzene exposure.
HISTOPATHOLOGY: Test article-related organ pathology was present in the lung, liver, thyroid gland and pituitary gland of ethylbenzene exposed mice. There were no treatment related effects on the reproductive organs
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Ethylbenzene at atmosphric concentrations up to 750 ppm for 2 years had no adverse effect on the reproductive organs of male or female mice as determined by histopathological examination.
- Executive summary:
Refer to section 7.5.2. Repeated dose toxicity: inhalation: KS_NTP_1999_104 Week Inhalation Mice
Ethylbenzene at atmosphric concentrations up to 750 ppm for 2 years had no adverse effect on the reproductive organs of male or female mice as determined by histopathological examination.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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