Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
235.09 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
17 631.58 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAECcorr=NOAELoral*(1/0.38 m³/kg/d)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 10000 mg/kg/d*(1/0.38 m³/kg/d)*(1/1)*0.67 = 17631.58 mg/m³. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
DNEL is based on an oral subacute (28-day) toxicity study
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling already included in ECHA starting point derivation method
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
33.33 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL=NOAELoral*( ABSoral-rat/ABSdermal-human) = (10000 mg/kg bw/day)*(1/1) = 10000 mg/kg bw/day. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
DNEL is based on an oral subacute (28-day) toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on a study in rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

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:
57.97 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
8 695.65 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAECcorr=NOAELoral*(1/1.15 m³/kg/d)*(ABSoral-rat/ABSinh-human) = 10000 mg/kg/d*(1/1.15 m³/kg/d)*(1/1) = 8695.65 mg/m³. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
DNEL is based on an oral subacute (28-day) toxicity study
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling already included in ECHA starting point derivation method; no further factor required.
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
for general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.67 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL=NOAELoral*( ABSoral-rat/ABSdermal-human) = (10000 mg/kg bw/day)*(1/1) = 10000 mg/kg bw/day. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
DNEL is based on an oral subacute (28-day) toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on a study in rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
for general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.67 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
10 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation needed
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
DNEL is based on an oral subacute (28-day) toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on a study in rat
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
for general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population