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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study, published in peer reviewed literature, fully adequate for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
- Reference Type:
- publication
- Title:
- Isoprene, An Endogenous Hydrocarbon And Industrial Chemical, Induces Multiple Organ Neoplasia In Rodents After 26 Weeks Of Inhalation Exposure
- Author:
- Melnick RL et al
- Year:
- 1 994
- Bibliographic source:
- Cancer Res., Vol. 54, pp. 5333-5339.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- GLP compliance:
- yes
- 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:
- purity > 99%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, NY, USA
- Age at study initiation: At least 6 weeks
- Housing: Individually in wire mesh cages
- Diet: NIH-07 diet ad libitum except during the exposure periods
- Water ad libitum
- Acclimation period: 11-13 days
ENVIRONMENTAL CONDITIONS
- Temperature: 75±3°C
- Humidity: 55 ± 15%
- Air changes: 15 per hr
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Stainless steel Hazelton 2000 chambers (total volume 2.3 m3)
- Exposure apparatus: Vapours were generated in a Buchi Rotavapor system at 50°C
- Chamber concentrations of isoprene were regulated by adjusting metering valves into the exposure chamber
- The daily mean concentrations of isoprene was 99-100% of target concentration - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentrations in the chambers were measured continuously during the exposures with a Hewlett-Packard gas chromatograph equipped with a flame ionization detector.
t90 (time to reach 90% of target concentration) was approximately 12 mins. - Duration of treatment / exposure:
- 6 hours/day for 13 weeks
- Frequency of treatment:
- 5 days/week for 13 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 70, 220, 700, 2200, or 7000 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 195, 613, 1950, 6129 and 19,503 mg/m3
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- Post-exposure period: not applicable
Examinations
- Observations and examinations performed and frequency:
- BODYWEIGHTS / CLINICAL OBSERVATIONS
- Weekly
HAEMATOLOGY: Yes, Blood samples were collected for clinical pathology evaluations on days 4, 24 and at study termination
- Blood samples collected from supraorbital sinus of CO2 anaesthetised animals
- The following parameters were measured:
erythrocyte, leukocyte, and platelet counts, haemoglobin concentration, haematocrit, reticulocyte count, mean cell volume, mean cell haemoglobin and leukocyte differential counts
CLINICAL CHEMISTRY: Yes, Blood samples were collected for clinical pathology evaluations on days 4, 24 and at study termination
- Blood samples collected from supraorbital sinus of CO2 anaesthetised animals
- The following parameters were measured:
urea nitrogen, creatinine, alanine aminotransferase, glutamate dehydrogenase and sorbitol dehydrogenase
URINALYSIS: Yes, All animals in study week 12
- Urinalysis of overnight urine samples. The following parameters were measured: glucose, creatinine, alkaline phosphatase and aspartate aminotransferase concentrations - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. Complete necropsies were performed on all animals.
ORGAN WEIGHTS: Yes. Brain, heart, right kidney, liver, lung, spleen, right testis, and thymus were weighed prior to fixation.
HISTOPATHOLOGY: Yes. Tissue samples, preserved in 10% neutral buffered formalin, were embedded in paraffin, sectioned, and stained with haematoxylin and eosin. -Tissues examined: gross lesions and tissue masses, adrenal glands, brain, oesophagus, femur and marrow, heart, small intestine, large intestine, kidneys, larynx, liver, lungs, lymph nodes (bronchial, mediastinal, mandibular, and mesenteric), mammary gland with adjacent skin, nasal cavity and turbinates, ovaries, pancreas, parathyroid glands, pituitary gland, preputial gland, prostate gland, salivary glands, spinal cord, and sciatic nerve, spleen, forestomach, glandular stomach, testes with epididymis and seminal vesicle, thymus, thyroid gland, trachea, urinary bladder, and uterus. - Statistics:
- Analysis of survival and incidence of neoplastic and nonneoplastic lesions was performed. Clinical chemistry, haematology, and urine data were analyzed by nonparametric methods (Shirley (1977) or Dunn (1964)).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Following 13 week inhalation exposure to 7000 ppm (19,503 mg/mg3) isoprene, no treatment-related effects were observed in rats.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 19 503 mg/m³ air (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Based on lack of toxicological effects in rats exposed up to 7000 ppm (19,503 mg/m3) isoprene for 13 weeks.
- Dose descriptor:
- LOAEC
- Effect level:
- > 19 503 mg/m³ air (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Based on lack of toxicological effects in rats exposed up to 7000 ppm (19,503 mg/m3) isoprene for 13 weeks.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No toxicological effects were evident in rats exposed up to 7000 ppm (19,503 mg/m3) isoprene for 13 weeks.
- Executive summary:
In a sub-chronic inhalation toxicity study, Fischer 344 rats (10/sex/concentration) were exposed via whole body inhalation to vapours of isoprene at concentrations of 0, 70, 220, 700, 2200, or 7000 ppm (0, 195, 613, 1950, 6129 and 19,503 mg/m3) 6 hours/day, 5 days per week for a period of 13 weeks.
No toxicological effects were evident in rats exposed up to 7000 ppm (19,503 mg/m3) isoprene for 13 weeks.
The NOAEC was determined to be 19,503 mg/m3.
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