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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
421 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):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
5 263 mg/m³
Explanation for the modification of the dose descriptor starting point:
Used 1/0.38 for respiratory volume rat to humans (8 hr); 6.7/10 for respiratory volume standard human to worker (8 hr)
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Sub chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
See above
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
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:
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)
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
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:
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

1. Overview of typical dose descriptors for all endpoints

Repeated dose:  90 day dietary study in rats NOAEL > 4257 mg/kg/bw/day. No treatment related effects were seen at highest dose tested.(Sci Assoc. 1966a) Reproductive effects: OECD 422 (dietary) study in rats NOAEL of > 2000 mg /kg bw/day. No treatment related effects were seen at highest dose tested. Developmental effects: OECD 422 (dietary) study in rats NOAEL of > 2000 mg /kg bw/day. No treatment related effects were seen at highest dose tested.

Selection of study upon which to base the DNEL: OECD 422 dietary study in rats NOAEL of > 2000 mg/kg bw/day. No treatment related effects were seen at highest dose tested. 

DNEL (Worker) dermal > 40 mg/kg/day.

DNEL (Worker) Inhalation > 421 mg/m3

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
69.57 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):
25
Modified dose descriptor starting point:
NOAEC
Value:
1 739 mg/m³
Explanation for the modification of the dose descriptor starting point:
Used 1/1.15 for respiratory volume rat to humans (24 hr);
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
See above
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
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:
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:
DNEL (Derived No Effect Level)
Value:
20 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):
25
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
4
Justification:
default
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default
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:
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:
20 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):
25
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
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:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

1. Overview of typical dose descriptors for all endpoints

Repeated dose:  90 day dietary study in rats NOAEL > 4257 mg/kg/bw/day. No treatment related effects were seen at highest dose tested.(Sci Assoc. 1966a) Reproductive effects: OECD 422 (dietary) study in rats NOAEL of > 2000 mg /kg bw/day. No treatment related effects were seen at highest dose tested. Developmental effects:OECD 422 (dietary) study in rats NOAEL of > 2000 mg /kg bw/day. No treatment related effects were seen at highest dose tested.

Selection of study upon which to base the DNEL: OECD 422 dietarystudy in rats NOAEL of > 2000 mg/kg bw/day. No treatment related effects were seen at highest dose tested. 

DNEL (oral, consumer):> 20 mg/kg/day.

DNEL (dermal, consumer):> 20 mg/kg/day

DNEL (inhalation, consumer) > 69.57 mg/m3