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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
49 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
36
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:

The corrected inhalatory NOAEC is obtained by multiplying (allometric scaling) the NOAEL with 1/0.38 m³/kg/day * 6.7 m³ / 10 m³ as 1763 mg/m³ .

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
chronic to subacute extrabolation according to guidance
AF for interspecies differences (allometric scaling):
3
Justification:
based on ECETOC (2010) (Technical Report ‘Guidance on Assessment Factors to Derive DNELs’, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium, 2010)
AF for other interspecies differences:
1
Justification:
based on ECETOC (2010) (Technical Report ‘Guidance on Assessment Factors to Derive DNELs’, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium, 2010)
AF for intraspecies differences:
1
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2
Justification:
see explanation below
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
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:
42 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

see explanation below

AF for dose response relationship:
1
Justification:
see explanation below
AF for differences in duration of exposure:
2
Justification:
see explanation below
AF for interspecies differences (allometric scaling):
4
Justification:
see explanation below
AF for other interspecies differences:
1
Justification:
see explanation below1000
AF for intraspecies differences:
3
Justification:
see explanation below
AF for the quality of the whole database:
1
Justification:
see explanation below
AF for remaining uncertainties:
1
Justification:
see explanation below
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:
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:
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:
25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: based on ECETOC (2010) (Technical Report ‘Guidance on Assessment Factors to Derive DNELs’, European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC), Brussels, Belgium, 2010)
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
See explanation below
AF for differences in duration of exposure:
2
Justification:
See explanation below
AF for interspecies differences (allometric scaling):
4
Justification:
See explanation below
AF for other interspecies differences:
1
Justification:
See explanation below
AF for intraspecies differences:
5
Justification:
See explanation below
AF for the quality of the whole database:
1
Justification:
See explanation below
AF for remaining uncertainties:
1
Justification:
See explanation below
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:
25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: See explanation below
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
See explanation below
AF for differences in duration of exposure:
2
Justification:
See explanation below
AF for interspecies differences (allometric scaling):
4
Justification:
See explanation below
AF for other interspecies differences:
1
Justification:
See explanation below
AF for intraspecies differences:
5
Justification:
See explanation below
AF for the quality of the whole database:
1
Justification:
See explanation below
AF for remaining uncertainties:
1
Justification:
See explanation below
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

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