Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.76 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
Dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
44 mg/m³
Explanation for the modification of the dose descriptor starting point:

Standard guidance calculations were employed.

AF for dose response relationship:
1
Justification:
ECHA default; a clear dose response was observed for the key findings.
AF for differences in duration of exposure:
2
Justification:
Extrapolation from a mid-term study period to a chronic study period. In the 2011 pulication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for OXEMA indicates it is metabolised well and does not have the potential to bioaccumulate. Consequently a lower factor of 2 is considered appropriate for the duration extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
route to route extrapolation addresses allometric scaling
AF for other interspecies differences:
2.5
Justification:
ECHA guidance
AF for intraspecies differences:
5
Justification:
ECHA guidance
AF for the quality of the whole database:
1
Justification:
Reliable well performed studies form the basis of the DNEL derivation
AF for remaining uncertainties:
1
Justification:
ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL extrapolated from long term DNEL

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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
Dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
AF for dose response relationship:
1
Justification:
ECHA guidance
AF for differences in duration of exposure:
2
Justification:
ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default factor used
AF for other interspecies differences:
2.5
Justification:
ECHA default factor used
AF for intraspecies differences:
5
Justification:
ECHA default factor used
AF for the quality of the whole database:
1
Justification:
ECHA default factor used
AF for remaining uncertainties:
1
Justification:
ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

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
DNEL related information
Justification:
ECHA guidance
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

There are no general population and consumer uses for the registered substance.