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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
Endpoint summary
Administrative data
Description of key information
The acute toxicity data on isoprene are limited. Using a weight-of-evidence approach, the available data suggest that isoprene has a low order of acute toxicity in animals by the oral, dermal and inhalation routes of exposure.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Predates GLP and OECD guidelines, but otherwise sufficient for assessment.
- Principles of method if other than guideline:
- 15 male Wistar rats were administered single doses of isoprene in oil by stomach tube. LD50 was calculated according to Litchfield & Wilcoxon (1949).
- GLP compliance:
- not specified
- Test type:
- other: unknown
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 160-210 g
- Route of administration:
- other: by stomach tube
- Vehicle:
- other: plant oil
- Doses:
- unknown
- No. of animals per sex per dose:
- 250, 500, 1000, 2000, 2150, 2250 and 2500 mg/kg
- Control animals:
- not specified
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 125 mg/kg bw
- Remarks on result:
- other: 2043 - 2210 mg/kg
- Mortality:
- There were no deaths up to and including 1000 mg/kg.
There were 4, 8, 11 and 15 mortalities at 2000, 2150, 2250 and 2500 mg/kg respectively, with first deaths reported after 1 day of exposure. - Clinical signs:
- other: At >= 500 mg/kg animals showed signs of sedation and had breathing difficulties after 1 hour's exposure. These observations were reported up to 7 days.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- 15 male Wistar rats were administered single doses of isoprene in oil by stomach tube. LD50 was concluded to be 2043 - 2210 mg/kg bw
- Executive summary:
In a Key pre-guideline study, 15 male Wistar rats were administered isoprene in oil by stomach tube at single doses of 250, 500, 1000, 2000, 2150, 2250 and 2500 mg/Kg.
No mortality was observed at doses up to and including 1000 mg/kg. There were 4, 8, 11, and 15 mortalities observed at 2000, 2150, 2250, and 2500 mg/Kg doses, respectively, with first deaths reported post day 1 of exposure. At =500 mg/Kg, animals showed signs of sedation and had breathing difficulties after 1 hour's exposure. These observations were reported up to 7 days.
The acute oral LD50 was concluded to be 2043 - 2210 mg/Kg bw in male Wistar rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Lethality study only; insufficient experimental detail to assess quality.
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Species:
- mouse
- Route of administration:
- inhalation
- Duration of exposure:
- 4 h
- Dose descriptor:
- LC50
- Effect level:
- 214 000 mg/m³ air
- Exp. duration:
- 4 h
- Clinical signs:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Insufficient experimental detail to assess quality.
- Principles of method if other than guideline:
- 5 rats received single application of 1 mL/kg isoprene each on their back skin (animals had been shaved the day before application). The substance was not removed for 7 days.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- weight 160-210 g
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 mL/kg bw
- Remarks on result:
- other: >679 mg/kg bw
- Interpretation of results:
- other: Not classified
- Conclusions:
- An acute dermal LD50 of >1 mL/kg bw was established.
- Executive summary:
5 rats received single application of 1 mL isoprene each on their back skin (animals had been shaved the day before application). The substance was not removed for 7 days.
An acute dermal LD50 of >1 mL/kg bw (>679 mg/Kg bw) was established.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
The oral LD50 of isoprene is reported as 2125 mg/kg (range of 2,043 to 2,210 mg/kg) and the 4-hour inhalation LC50 in rat is 180,000 mg/m3 and 2-hour LC50 in the mouse is 157,000 mg/m3.
The dermal LD50 of isoprene is >679 mg/kg (> 1mL/kg). Considering read-across from 2 -methyl-2 -butene (structurally similar to isoprene), it is considered that weight of evidence suggest an LD50 in excess of 2000 mg/kg.
Justification for classification or non-classification
No classification for acute toxicity is warranted under CLP since the oral and dermal LD50 values are >2000 mg/kg and the inhalation LC50 exceeds 20,000 mg/m3.
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