Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 302-639-3 | CAS number: 94114-03-1 A distillation fraction from the hydrogenation of pyrolysis gasoline boiling in the range of approximately 20°C to 200°C (68°F to 392°F).
- 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:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP status unknown, near guideline study, published in peer reviewed literature, adequate for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Chronic inhalation oncogenicity study of isoprene in B6C3F1 mice
- Author:
- Placke M, Griffis L, Bird M, Bus J, Persing R and Cox L Jr.
- Year:
- 1 996
- Bibliographic source:
- Toxicology, Vol. 113, pp. 253-262
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Isoprene
- EC Number:
- 201-143-3
- EC Name:
- Isoprene
- Cas Number:
- 78-79-5
- Molecular formula:
- C5H8
- IUPAC Name:
- isoprene
- Details on test material:
- - Name of test material (as cited in study report): isoprene
- Source: Goodyear Tire & Rubber Company, Beaumont, Texas, USA
- Analytical purity: >99%
- The test material contained less than one percent limonene (a degradation product)
- Tert-butyl catechol (TBC) was added by the supplier as a stabilizer at a target concentration of 50 ppm. TBC in each cylinder was measured and did not exceed 100 ppm for the initial cylinder analyses, with a measured range of between 4.1-95.3 ppm.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River's Portage Laboratory
- Age at study initiation: no older than 10 weeks
- Housing: individually housed in stainless steel wire-mesh inhalation cages that fitted into the exposure chambers
- Diet: Certified Purina Rodent Chow in pellet form ad libitum except during exposure
- Water: ad libitum except during exposure
- Acclimation period: 25 days
- Prior to the study, sera were collected from at least 5 mice/sex and were found free of antibody titers to common murine pathogens.
ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C (chamber)
- Humidity: 40-70% (chamber)
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exposure chambers (Hazelton H1000 or H2000, 1000 or 2000 L in volume)
- Method of holding animals in test chamber: stainless steel wire-mesh cages
- Test atmospheres were generated from the liquid as an aerosol by ultrasonic nebulization followed by evaporation in a stainless steel aging plenum
- Filtered compressed air was supplied to the ultrasonic spray nozzle. Isoprene was fed to the spray nozzle from the storage cylinder which was pressurized with N2 at 5 psig.
- Room air was drawn into the aging plenum through charcoal and high efficiency particulate air (HEPA) filters and carried isoprene vapour to the exposure chambers through a common distribution manifold with subsequent dilution at each chamber to the target concentrations.
- Temperature: 22±2°C (range:22.1 to 22.7°C); humidity 40-70% (range: 52.3 to 55.0%)
- Chamber flow was a nominal 15 air changes per h
- Chamber pressure and flowrate were monitored continuously during exposures.
TEST ATMOSPHERE
- Brief description of analytical method used: A Miran-980 infrared spectrometer (IR) was used to measure isoprene concentrations in the chambers and exposure room.
- An hourly sampling sequence was used to minimize the step change in concentration among chambers.
- Some chamber samples were also analyzed with a gas chromatograph with a Flame Ionization Detector, primarily to determine the concentrations of limonene (isoprene dimer).
- Uniformity within the exposure chambers was verified by measuring the isoprene concentration at the front, middle, and back of each chamber level.
- Samples taken from breathing zone: yes - Duration of treatment / exposure:
- 20, 40 or 80 weeks
- Frequency of treatment:
- 4 or 8 hrs/day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 70, 140, 280, 700, 2200 ppm/ 4 or 8 hours/day, 5
Basis:
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
- Positive control(s):
- none
Examinations
- Tissues and cell types examined:
- Micronucleated polychromatophilic or orthochromophilic erythrocytes
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES:
- Evaluations of peripheral blood were performed on 10 animals per exposure group using samples obtained the day after the last exposure for those groups ending exposure after 40 and 80 weeks.
- Ten controls were also sampled when an exposed group was.
DETAILS OF SLIDE PREPARATION:
- A slightly modified method (micronucleated polychromatophilic or orthoch-romophilic erythrocytes were counted) as de-scribed by Miller (1973) was used.
- A total of 2000 erythrocytes from each animal were evaluated. - Statistics:
- Results from the micronucleus evaluation were analyzed using one way analysis of variance or a nonparametric test (Kruskal-Wallis and Dunn's summed rank).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- positive
- Toxicity:
- no effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
Any other information on results incl. tables
After 40 weeks of exposure, controls, 70 ppm and 140 ppm groups had similar group mean values. 2200 ppm animals had micronucleus counts that were significantly increased (147%) compared to controls. After 80 weeks of exposure, controls, 10 ppm and 70 ppm animals had similar values. All mice exposed to higher concentrations of isoprene (≥280 ppm) had significantly greater micronuclei values compared to controls. 280 ppm, 700 ppm, 2200 ppm/4 h and 2200 ppm animals were 92, 133, 167, and 125% higher, respectively, than the controls.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
Exposure to isoprene resulted in genotoxic effects with the mean incidence of micronuclei in peripheral blood significantly (p≤0.05) greater at 700 ppm or higher after 80 weeks. - Executive summary:
The mean incidence of micronuclei in peripheral blood was significantly increased at 700 ppm and higher after 80 weeks. Similar effects were observed after 40 weeks, although only the 2200 ppm animals had significant elevations of micronuclei compared to the control, 70 and 140 ppm groups. (The 280 and 700 ppm groups were not sampled at 40 weeks). There was no apparent relationship to exposure duration or cumulative exposure on the incidence of micronuclei.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.