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EC number: 201-143-3 | CAS number: 78-79-5
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, published in peer reviewed literature, no restrictions, fully adequate for assessment.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Reference Type:
- publication
- Title:
- Inhalation developmental toxicity of isoprene in mice and rats.
- Author:
- Mast TJ et al
- Year:
- 1 990
- Bibliographic source:
- Toxicologist 10(1):42 (abstract)
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Isoprene
- EC Number:
- 201-143-3
- EC Name:
- Isoprene
- Cas Number:
- 78-79-5
- Molecular formula:
- C5H8
- IUPAC Name:
- 2-methylbuta-1,3-diene
- Details on test material:
- - Name of test material (as cited in study report): isoprene
- Analytical purity: >99.7%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Portage, MI, USA
- Age at study initiation: 12 week
- Housing: Virgin females individually caged 8 days prior to exposure, mated females individually caged on 0 dg
- Diet: pelleted NIH-07 diet (Ziegler Bros ., Inc ., Gardner, PA, USA) ad libitum (except during exposure)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 75±3°F
- Humidity: 55±15%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark /12 hrs light
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- other: air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 2 .3 m3 stainless-steel chamber (1 .7 m3 active mixing volume) contained 3 levels of caging, each of which was split into 2 offset tiers. The cage units accommodated individual animal cages, feed troughs and automatic water dispensers. Stainless-steel catch pans designed to aid in maintaining a uniform concentration of vapour throughout the chamber, as well as for the collection of urine and faeces, were suspended below each cage unit.
- Rate of air: 15 ft3/min. The uniform mixture was diverted along the inner surfaces of the chamber and the catch pans created mixing eddies
- Method of conditioning air: HEPA- and charcoal-filtered.
- Isoprene vapour was generated by a rotary evaporation system which assured uniformity of chemical-laden atmosphere within the chamber.
- Temperature and humidity in air chamber: 75±3°F, 55±15%
- Air flow rate: 12 to 18 CFM
TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentrations of isoprene vapour in the chambers were monitored at 20-30 min intervals by gas chromatography (minimum detectable limit = 0.04 ppm isoprene). The grand means of chamber concentrations for all exposure levels were 100% of the target with relative SDs of 2 to 6%. At least 99% of all individual concentration measurements were within ±10% of the specified operating limits for the exposure target level. There was no measurable concentration in the control and holding chambers. The maximum concentration observed in the room was 0 .8 ppm.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 2-3 females/male
- Length of cohabitation: overnight
- Further matings: none
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal plug referred to as day 0 of gestation (0dg) - Duration of treatment / exposure:
- 12 consecutive days. gestation days 6-17
- Frequency of treatment:
- 6 hours/day
- Duration of test:
- days 0-18 of gestation
- No. of animals per sex per dose:
- 10 virgin females/group and 33 positively mated females /group.
- Control animals:
- yes, sham-exposed
- Details on study design:
- Virgin mice were exposed for 12 consecutive days concurrently with mated animals and were killed 1 day after their last exposure day.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Mated mice 0, 6, 9, 12, 15 and 18 dg. Virgin mice 3 days prior to exposure and on exposure days 1, 5, 10 and at termination.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 18 mated mice, 1 day after final exposure virgin mice
- Organs weighed: liver and kidneys
- Organs examined: ovaries, uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: No data (ovaries examined at another laboratory and results not included in this publication)
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - Live foetuses were weighed examined for gross defects, and their sex was determined by internal examination of the gonads
- External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [half per litter plus any with gross external abnormalities]
- Skeletal examinations: Yes: [all per litter]
- Head examinations: Yes: [half per litter] - Statistics:
- All means and SDs for animal data were calculated with SAS statistical software. Mean body weights (as a mean of litter means for foetal data) were analyzed with an analysis of variance (ANOVA) model for unbalanced data. Response variables, either body weight or the arcsin transformations of proportional incidence data, were analyzed against the class variable, "treatment", in a one-way ANOVA model. A Tukey's t-test (two-tailed) was used to assess statistically significant differences between control and exposed groups. If appropriate, the dose-response relationship was determined by means of an orthogonal trend test. In the case of proportional data the t-tests and trend analyses were performed on transformed variables. The litter was used as the basis for analysis of foetal variables.
- Historical control data:
- reported
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
There were statistically significant reductions in maternal body weight and body weight gain and, in uterine weight at the highest dose. Liver to body weight ratios for pregnant dams were significantly increased in the 1400 and 7000 ppm groups compared to the control group, and kidney to body weight ratios were significantly increased in the 7000 ppm group.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- 3 900 mg/m³ air (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
There was an exposure-correlated reduction in foetal body weight (statistically significant for females only at 780 mg/m3, for males only at 3900 mg/m3 and for males and females at 19,503 mg/m3). There was no increase in the incidence of foetal malformations although two foetuses with cleft palate were found, one in each of the two highest exposure groups (1400 and 7000 ppm). An increased incidence of supernumerary ribs was observed in the exposed groups. This skeletal variation is generally considered to be a secondary effect of maternal toxicity or stress and its significance is unclear. The incidence of supernumerary ribs (percent of foetuses examined) was 20.1, 23.8, 33.6, and 40.3% at 0, 780, 3900, and 19,503 mg/m3.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 19 503 mg/m³ air (nominal)
- Basis for effect level:
- other: teratogenicity
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- 780 mg/m³ air (nominal)
- Basis for effect level:
- other: Developmental Toxicity. statistically significant differences in foetal weight in the absence of maternal toxicity; no NOAEC
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEC for maternal toxicity was 3900 mg/m3 (1400ppm). The NOAEC for teratogenicity was 19,503 mg/m3 (7000 ppm). The NOAEC for developmental toxicity based on foetal weight effect was not established and is therefore <780 mg/m3 (<280 ppm).
- Executive summary:
Exposure of Swiss (CD-1) mice to 0, 780, 3900 or 19,503 mg/m3 (0, 280, 1400 or 7000 ppm) isoprene resulted in significant reductions in maternal body weight and uterine weight at the highest exposure. There was no NOAEC for developmental toxicity, which was evident as an exposure-correlated reduction in foetal body weight (statistically significant for females only at 780 mg/m3 , for males only at 3900 mg/m3 and for males and females at 19,503 mg/m3). The incidence of foetuses with supernumerary ribs was statistically significant at 3900 mg/m3. There was no significant increase in the incidence of malformations. Two foetuses with cleft palate were observed, one in each of the two highest exposure groups. This low incidence of a relatively common finding in mice, is considered not to be indicative of teratogenicity / developmental toxicity.
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