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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
Value:
120 mg/kg bw/day
Modified dose descriptor starting point:
other: NOAEL
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
Value:
120 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
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

The Worker DNELs have been included in the REACH registration for completeness. No exposure assessment has been conducted as the substance is not present in concentrations which would lead to polymers being classified as hazardous under the CLP regulation.  No performance of the exposure assessment is further supported with 3 documents attached in Section 13.2 of this REACH registration.

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.

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