Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: See discussion below
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
DNEL value:
122 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
No interspecies factor is required because this is an inhalation study
AF for other interspecies differences:
1
Justification:
No additional factor deemed necessary. See attachment to this record in IUCLID dossier
AF for intraspecies differences:
3
Justification:
See attachment to this record in IUCLID dossier
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: See discussion below
Explanation for the modification of the dose descriptor starting point:
There is no repeat dose dermal study available for this substance. A chronic study is available by the inhalation route . See justification below for details extrapolation from the inhalation to the dermal DNEL.
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:
DNEL (Derived No Effect Level)
Value:
12.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: See discussion below
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
DNEL value:
122 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
No interspecies factor is required because this is an inhalation study
AF for other interspecies differences:
1
Justification:
No additional factor deemed necessary. See attachment to this record in IUCLID dossier
AF for intraspecies differences:
5
Justification:
See attachment to this record in IUCLID dossier
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Explanation for the modification of the dose descriptor starting point:
There is no repeat dose dermal study available for this substance. A chronic study is available by the inhalation route. See justification below for details of extrapolation from the inhalation to the dermal DNEL.
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:
DNEL (Derived No Effect Level)
Value:
0.16 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: See justification below
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Default for extrapolation from sub-acute to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default for extrapolation from rats to humans
AF for other interspecies differences:
1
Justification:
No additional factor deemed necessary. See attachment to this record in IUCLID dossier
AF for intraspecies differences:
5
Justification:
See attachment to this record in IUCLID dossier
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

Note that derivation of consumer DNELs is somewhat academic as there are no consumer uses for this substance.