Registration Dossier
Registration Dossier
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EC number: 201-143-3 | CAS number: 78-79-5
Endpoint summary
Administrative data
Description of key information
Using a weight-of-evidence approach, isoprene appears to have a low potential for eye, skin and respiratory tract irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation
- Remarks:
- no data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Insufficient experimental detail to assess quality.
- Principles of method if other than guideline:
- No specific information on methodology
- Remarks on result:
- other: isoprene caused eye irritation, no further data given
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin Irritation
Non-human information
Details are only available for the study conducted by Bayer (1972) (cited in SIAR, 2005). In this skin irritation study, the skin of two New Zealand White rabbits was painted twice per day for 5 consecutive days with 100% isoprene. Reversible erythema was observed. Using a weight-of-evidence approach, the data suggest that isoprene has a low potential for skin irritation. The results from QSAR Toolbox show that skin irritation/corrosion inclusion rules by BfR are not met and skin irritation/corrosion exclusion rules by BfR are undefined. The QSAR results suggest that isoprene should be "not classified" for skin irritation and corrosion.
Human information
No relevant human information available.
Eye Irritation
Non-human information
Isoprene was reported to cause eye irritation in rats in a non-GLP study conducted by Mamedov (1979) (reliability unassignable due to lack of experimental details). The results from QSAR Toolbox show that eye irritation/corrosion inclusion rules by BfR are not met and eye irritation/corrosion exclusion rules by BfR are undefined. The QSAR results suggest that isoprene should be "not classified" for eye irritation and corrosion.
Human information
No relevant human information available.
Respiratory Tract Irritation
Non-human information
No indication of respiratory irritation was noted in male and female rats and female mice exposed to up to 7000 ppm (19,503mg/m3) isoprene for 6 hours/day, 5 days/week for 13 weeks (Melnick et al., 1994). In male mice, however, degeneration of the olfactory epithelium was observed at 7000 ppm, but not at lower concentrations. The NOAEC in this study was 2200 ppm (6129 mg/m3). Olfactory degeneration is not necessarily a result of respiratory irritation.
Human information
Slight irritation of the upper respiratory tract was reported in human volunteers exposed to 57 ppm or 160 mg/m3 (Gostinskii, 1965)
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Isoprene is not classified for skin, eye or respiratory tract irritancy under CLP and considering the weight of evidence, no classification is warranted under CLP.
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