Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.3 mg/m³
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
other: NOAEL
DNEL value:
400 mg/m³
Explanation for the modification of the dose descriptor starting point:
The oral NOAEL = 450 mg/kg-day from the 28-oral toxicity (gavage) study with MV31 in male and female Wistar rats was used to derive the inhalation dose descriptor for MV31. This oral NOAEL was converted, using ECHA Guidance (specifically: Example B.3 of Appendix 8-2 of Chapter R.8., Version 2.1; November 2012). The inputs were as follows: sRV rat = 0.38 m3/kg-day (for 8-hours); ABS oral-rat = 50%; ABS inhalation-human = 100%; and sRVhuman/wRV = 0.67. This gave the corrected inhalation NOAEL = 400 mg/m3.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
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:
1.5 mg/kg bw/day
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
DNEL value:
450 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The oral NOAEL = 450 mg/kg-day from the 28-oral toxicity (gavage) study with MV31 in male and female Wistar rats was used to derive the inhalation dose descriptor for MV31. This oral NOAEL was converted, using ECHA Guidanc, to a corrected dermal NOAEL by multiplying by a default absorption factor = 1. Regarding the use of this default factor, ECHA (Chapter R.8) states that, “in general, dermal absorption will not be any higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral to dermal extrapolation.” Therefore, the oral NOAEL (450 mg/kg-day) was used as the corrected dermal NOAEL.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
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:
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