Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.