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EC number: 240-347-7 | CAS number: 16219-75-3
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Study conducted in an established laboratory according to the Rodent Dominant Lethal Assay Guideleines of the U.S. EPA (1982) and in full compliance with GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Absence of dominant lethal effects in male CD® rats exposed to 5-ethylidene-2-norbornene vapor.
- Author:
- Neeper-Bradley, T. and Ballantyne, B.
- Year:
- 1 996
- Bibliographic source:
- Toxic Substance Mechanisms 15, 389-404.
Materials and methods
- Principles of method if other than guideline:
- This study design was based on guidelines supplied by the United States EPA for the "Rodent Dominant Lethal Assay" (1982). Other sources examined for development of the study design included Green et al (1976; 1985) and Ehling et a1. (1978).
- GLP compliance:
- yes
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- 5-ethylidene-8,9,10-trinorborn-2-ene
- EC Number:
- 240-347-7
- EC Name:
- 5-ethylidene-8,9,10-trinorborn-2-ene
- Cas Number:
- 16219-75-3
- Molecular formula:
- C9H12
- IUPAC Name:
- 5-ethylidenebicyclo[2.2.1]hept-2-ene
- Details on test material:
- Test substance: 5-Ethylidene-2-norbornene (CAS No. 16219-75-3)
Reference no 1-SCD-113.
Purity: 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- All animals were assigned a unique number and identified by cage tags.
TEST ANIMALS
- Source: Charles River Laboratories, Inc. (Portage, MI)
- Age at study initiation: 70 days of age
- Housing: During the acclimation period and prior to mating, animals were housed separated by sex, 1 male or 2 females to a cage, in stainless steel wire-mesh cages. After the exposure period, the males were housed in stainless steel wire-mesh cages with 2 females weekly, for mating. After successful mating, the females were housed individually.
- Diet: Ground, certified Rodent Diet (RMH 3200, Agway, Inc.) was available ad libitum, except during exposures.
- Water: Tap water was available ad libitum, except during exposures.
- Acclimation period: The acclimation period for each shipment of animals was approximately 2 weeks. During this period, the animals were weighed at least 2 times at scheduled intervals.
ENVIRONMENTAL CONDITIONS
- Temperature: 66-75°F.
- Humidity: 40-70%
- Photoperiod: 12-hour photoperiod (approximately 0500 to 1700 hours for the light phase).
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- No
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Exposure cages were stainless steel with glass windows for observation and were approximately 1330 liters
- System of generating particulates/aerosols: Liquid ENB was metered from a piston or syringe pump into a heated glass evaporator (55-66 Celsius) similar in design to that described by Snellings and Dodd (1990). The resulting ENB vapor was carried into the exposure chamber by a countercurrent air stream that entered the bottom of the evaporator and flowed into the chamber from the top of the evaporator.
- Temperature: 21.8-22.6 Celsius.
- Humidity: 55.1-61.4%,
- Air flow rate: approximately 300 liters/minute
- Air change rate: 13 air changes each hour - Duration of treatment / exposure:
- 6 hours/day for 5 days
- Frequency of treatment:
- 5 consecutive days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 ppm (analytical)
- Dose / conc.:
- 52 ppm (analytical)
- Dose / conc.:
- 254 ppm (analytical)
- No. of animals per sex per dose:
- 20 exposed males per group
40 untreated females per group were used for each mating week - Control animals:
- other: Yes, exposed to filtered air. Following the final exposure to filtered air, positive control males received a single intraperitoneal injection of 0.5 mg TEM/kg body weight.
- Positive control(s):
- Triethylenemelamine
Examinations
- Evaluation criteria:
- Reproductive/gestational parameters examined included: No. impregnated females/no. females paired (mating index, females):
No. impregnating males/no. males paired (mating index, males):
No. pregnant females/no. females impregnated (fertility index, females):
No. males producing pregnant females/no. males impregnating (fertility index, males):
No. corpora lutea/pregnant female:
No. total implantations/pregnant female:
Preimplantation loss/pregnant female (%):
No. nonviable implantations (early and late resorptions and
dead fetuses)/pregnant female:
Postimplantation loss/pregnant female (%):
No. females with 1 or more dead implantations (%):
No. females with 2 or more dead implantations (%):
Ratio of nonviable implantations/total implantations:
FL% (the dominant lethal factor) =[ 1 - live implantations/female of test group ] X 100 / live implantations/female of control group - Statistics:
- The unit of comparison was the male or the pregnant female (Weil, 1970). Results of the quantitative continuous variables (for example, male body weights) were intercompared for the 3 ENB-treated groups and vehicle control group by use of Levene's test for equal variances (Levene, 1960), analysis of variance (ANOVA), and t-tests. The t-tests were used when the F value from the ANOVA was significant. When Levene's test indicated homogeneous variances, and the ANOVA was significant, the pooled t-test was used. When Levene's test indicated heterogeneous variances, all groups were compared by an ANOVA for unequal variances (Brown and Forsythe, 1970) followed, when necessary, by the separate variance t-test. The positive control group was compared to the vehicle control group using the previously described set of statistics.
Nonparametric data were examined statistically using the Kruskal-Wallis test (Sokal and Rohlf, 1969) followed by the Mann-Whitney U test (Sokal and Rohlf, 1969) when appropriate. Frequency data were compared using the Fisher's Exact Test (Sokal and Rohlf, 1969). For all statistical tests, the probability value of < 0.05 (two-tailed) was used as the critical level of significance.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- slight transient body weight effects at high dose
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
ENB did not produce evidence of dominant lethality in rats using a standard protocol (Neeper-Bradley and Ballantyne, 1996). Male rats exposed to analytically measured ENB vapor concentrations of 0, 5, 52, or 254 ppm for 6 hr/day for 5 consecutive days were mated with unexposed females.
Reproductive factors, including the number of fertile males and the number of gravid females with viable implants, were unaffected by exposure to ENB vapor. No significant preimplantation loss or dominant lethal effects were observed in females mated to ENB-exposed males during the 10-week breeding period. Males exposed to 254 ppm had slightly reduced body weight gains after the 5-day treatment period, but body weights and body weight gains were comparable to the controls thereafter. Triethylenemelamine (0.5 mg/kg, single dose on day 5 as a positive control) produced clear dominant lethal effects.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The ENB-exposed males showed no clinical signs of toxicity. The only objective finding was slight decrease in body weight gain at 254 ppm over the exposure period, but which resolved by the end of the first postexposure week. No reproductive or gestational effects, including dominant lethality, were noted in the ENB-treated groups during the 10 wk of postexposure mating. This finding confirms the absence of testicular toxicity in the rat from repeated exposure to high concentrations of ENB vapor. - Executive summary:
Neeper-Bradley and Ballantyne (1996) reported that ENB did not induce dominant lethal mutations in rats exposed to concentrations up to 254 ppm for 5 consecutive days (6 hr/day). The NOEC for toxicity (body weight gain) was 52 ppm. The NOEC for dominant lethality was greater than 254 ppm.
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