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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
8.4 mg/m³
DNEL related information
DNEL derivation method:
other: based on MAK value
Overall assessment factor (AF):
1
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:
DNEL (Derived No Effect Level)
Value:
40 mg/kg bw/day
DNEL related information
DNEL derivation method:
other: based on MAK value
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
other:
Value:
40 mg/kg bw/day
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

The MAK derived a workplace exposure limit (MAK-Wert) of 8.4mg/m³ based on the external exposure concentration, over 8h/day for 40 years, that would not increase baseline blood concentrations (area under the curve) above that arising from endogenous formation of isoprene. Such a concentration is, therefore, considered to offer no appreciable cancer risk (MAK, 2009).

Because the MAK value is based on the endogenous formation of isoprene, assessment factors are not considered appropriate (overall AF=1).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 mg/m³
DNEL related information
DNEL derivation method:
other: based on MAK value
Overall assessment factor (AF):
1
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:
DNEL (Derived No Effect Level)
Value:
9.5 mg/kg bw/day
DNEL related information
DNEL derivation method:
other: based on MAK value
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
other:
Value:
9.5 mg/kg bw/day
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:
DNEL (Derived No Effect Level)
Value:
0.2 mg/kg bw/day
DNEL related information
DNEL derivation method:
other: based on MAK value
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
other:
Value:
0.2 mg/kg bw/day
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

The MAK derived a workplace exposure limit (MAK-Wert) of 8.4mg/m³ based on the external exposure concentration, over 8h/day for 40 years, that would not increase baseline blood concentrations (area under the curve) above that arising from endogenous formation of isoprene. Such a concentration is, therefore, considered to offer no appreciable cancer risk (MAK, 2009). This value is converted, as approprirate, to account for differences in exposure patterns between workers and the general population.

Because the MAK value is based on the endogenous formation of isoprene, assessment factors are not considered appropriate (overall AF=1).