Registration Dossier
Registration Dossier
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EC number: 295-405-4 | CAS number: 92045-23-3 A complex combination of hydrocarbons produced by the distillation of the products of a steam cracking process. It consists predominantly of hydrocarbons having a carbon number of C4, predominantly 1-butene and 2-butene, containing also butane and isobutene and boiling in the range of approximately minus 12°C to 5°C (10.4°F to 41°F).
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 2.21 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Cox regression (see endpoint summary for details)
- Overall assessment factor (AF):
- 1
- Explanation for the modification of the dose descriptor starting point:
- no route-to-route extrapolation necessary
- AF for dose response relationship:
- 1
- Justification:
- accounted for in the model
- AF for differences in duration of exposure:
- 1
- Justification:
- accounted for in the model
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- model derived from human epidemiology studies
- AF for other interspecies differences:
- 1
- Justification:
- model derived from human epidemiology studies
- AF for intraspecies differences:
- 1
- Justification:
- accounted for in the model
- AF for the quality of the whole database:
- 1
- Justification:
- database is robust
- AF for remaining uncertainties:
- 1
- Justification:
- no unremaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
A DN(M)EL for acute effects should be derived if an acute hazard leading to acute toxicity (eg. C&L) has been identified and there is a potential for high peak exposures. This is not the case with members of this category.
The marker substance with the highest relative hazard potential was selected. Long term systemic effects are therefore defined by the carcinogenicity of 1,3-butadiene in humans. The DMEL of 2.21 is equivalent to 1ppm.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 0.265 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Cox regression (see endpoint summary for details)
- Overall assessment factor (AF):
- 1
- Explanation for the modification of the dose descriptor starting point:
- no route-to-route extrapolation necessary
- AF for dose response relationship:
- 1
- Justification:
- accounted for in the model
- AF for differences in duration of exposure:
- 1
- Justification:
- accounted for in the model
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- model derived from human epidemiology studies
- AF for other interspecies differences:
- 1
- Justification:
- model derived from human epidemiology studies
- AF for intraspecies differences:
- 1
- Justification:
- accounted for in the model
- AF for the quality of the whole database:
- 1
- Justification:
- database is robust
- AF for remaining uncertainties:
- 1
- Justification:
- no unremaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
A DMEL for acute effects should be derived if an acute hazard leading to acute toxicity (eg. C&L) has been identified and there is a potential for high peak exposures. This is not the case with members of this category.
The marker substance with the lowest DMEL was selected for population effects as these are most protective. Long term systemic effects are therefore defined by the carcinogenicity of 1,3-butadiene in humans
The DMEL of 0.2652 mg/m3for carcinogenicity is equivalent to 120 ppb. No long-term local effects have been reported.
The main use of hydrocarbon streams are as intermediates and monomers, hence exposure of the general population is likely to be low.
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.
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