Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.53 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
88.158 mg/m³
Explanation for the modification of the dose descriptor starting point:
Corrected inhalatory NAEC = Oral NOAEL x 1/sRVrat x Abs(oral, rat)/Abs(inhal, human) x sRV human/wRV for workers [with 100% abs. inhalation vs. 50% abs. oral]
AF for dose response relationship:
1
Justification:
NOAEL used as a starting point
AF for differences in duration of exposure:
2
Justification:
subchronic (OECD 408 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling because route-to-route extrapolation
AF for other interspecies differences:
2.5
Justification:
standard factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Standard factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not appplicable
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
In the absence of data on absorption via the dermal route, a default factor of 1 is applied as recommended by ECHA R8 guidance (dermal absorption is assumed not to be higher than oral absorption).
AF for dose response relationship:
1
Justification:
NOAEL used as a starting point
AF for differences in duration of exposure:
2
Justification:
subchronic (OECD 408 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor for rat to human extrapolation
AF for other interspecies differences:
2.5
Justification:
standard factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Standard factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation 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
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

The general population is not expected to be exposed to the registered substance. Indeed, the monomer is only used as an intermediate in industrial setting and is chemically transformed when used in polymer synthesis. Only traces amount are expected to be present as an impurity in the end-products.