Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.97 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEL
DNEL value:
120 mg/kg bw/day
Modified dose descriptor starting point:
other: NOAEL
DNEL value:
148 mg/m³
Explanation for the modification of the dose descriptor starting point:

Extrapolation from oral toxicity data to inhalation route.

DNEL = 120 mg/kg/bw * ((6.7/10) * (0.5) * (7/5) * (1/0.38)) = (148 mg/m3/ 75) = 1.97 mg/m3

AF for dose response relationship:
1
Justification:
ECHA R.8 guidance (route to route ABS included in dose descriptor)
AF for differences in duration of exposure:
6
Justification:
ECHA R.8 guidance (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA R.8 guidance (allometric scaling not required)
AF for other interspecies differences:
2.5
Justification:
ECHA R.8 guidance (interspecies rat to human)
AF for intraspecies differences:
5
Justification:
ECHA R.8 guidance (intraspecies worker)
AF for the quality of the whole database:
1
Justification:
Reliable OECD 421 study available.
AF for remaining uncertainties:
1
Justification:
No remaining 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:
DNEL (Derived No Effect Level)
Value:
0.56 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
DNEL value:
120 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
168 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification factor of 1.4 used to account for 7 days/week exposure in study to 5 days/week for worker conditions.

AF for dose response relationship:
1
Justification:
ECHA R.8 guidance (starting point a NOAEL; oral to dermal)
AF for differences in duration of exposure:
6
Justification:
ECHA R.8 guidance (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA R.8 guidance. Allometric scaling required (rat to humans)
AF for other interspecies differences:
2.5
Justification:
ECHA R.8 guidance (interspecies rat to human)
AF for intraspecies differences:
5
Justification:
ECHA R.8 guidance (intraspecies worker)
AF for the quality of the whole database:
1
Justification:
Reliable OECD 421 study available.
AF for remaining uncertainties:
1
Justification:
No remaining 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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

As the substance is imported into the EU/EEA as a monomer bound in polymer, there is no potential for exposure of the substance itself to the general population. Accordingly, no general population DNELs are calculated for this substance.