Registration Dossier
Registration Dossier
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EC number: 903-812-1 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 88 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Workers - Hazard for the eyes
Additional information - workers
This DMEL derivation is only valid if the substance contains > 0.1 % 1,3 -butadiene:
The DMEL for "Reaction mass of butane and butene" is based on the DMEL of 1,3 -butadiene which is present in the "Reaction mass of butane and butene" at concentrations above 0.1% and therefore triggers classification and labeling as carcinogen and mutagen. Limit values - eight hours for 1,3 -butadiene are as high as 10 ppm (= 22 mg/m3) in member states of the European Union. In the Reach dossier of 1,3 -butadiene a DMEL, inhalation (long-term exposure, systemic effects) of 1 ppm (=2.2 mg/m3) is suggested. This DMEL was modified due to the lower content of 1,3 -butadiene in "Reaction mass of butane and butene" and set at 40 ppm (= 88 mg/m3). This DMEL should sufficiently protect up to and including a maximum concentration of 2.5 % 1,3- butadien in "Reaction mass of butane and butene".
DNEL for Reaction mass of butane and butene with < 0.1 % 1,3-butadiene.
DNELs for the other substances in "Reaction mass of butane and butene" (Butene, 2 -methylpropene, butane and isobutane) are much higher than 40 ppm as indicated by EU limit values and the Reach dossiers of these substances. The lowest DNEL was 335 ppm (ca. 800 mg/m3) for butene and 2 -methylpropene. The eight hour limit values for butane and isobutane are set at 1000 ppm in Germany (2400 mg/m3).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Value:
- 2.64 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
Acute/short term exposure
- Hazard assessment conclusion:
- no data available: testing technically not feasible
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
This DMEL derivation is only valid if the substance contains > 0.1 % 1,3 -butadiene:
See also discussion section of the worker.
The consumer DMEL is based on the consumer DMEL of 1,3 -butadiene which was set at 30 ppb (= 0.0664 mg/m3).
This DMEL was modified due to the lower content of 1,3 -butadiene in "Reaction mass of butane and butene" and set at 1.2 ppm (= 2.64 mg/m3). This DMEL should sufficiently protect up to and including a maximum concentration of 2.5 % 1,3- butadien in "Reaction mass of butane and butene".
DNEL for Reaction mass of butane and butene with < 0.1 % 1,3-butadiene.
Consumer DNELs for Butene, 2 -methylpropene, butane and isobutane were at 71 ppm (ca. 170 mg/m3) or higher as indicated by the respective Reach dossiers.
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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