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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.73 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):
300
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
220 mg/m³
Explanation for the modification of the dose descriptor starting point:

In according to ECHA Practical Guide 14: How to prepare toxicological summaries in IUCLID and how to derive DNELs:

Inhalatory N(L)OAEC= oral N(L)OAEL*(1/0.38 m3 /kg/d)*0.67*(ABSoral/ABSinh.)

In according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8

50% (instead of 100%) adsorption is assumed for oral absorption, and 100% for inhalation

.

AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
5
Justification:
CHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
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:
8.33 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
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Extrapolation route to route: the dermal absorption is negligible; the  absorption from the gastrointestinal tract occurs

AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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:
0.18 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):
600
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
108.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

In according to Echa Practical Guide 14: How to prepare toxicological summaries in IUCLID and how to derive DNELs:

Inhalation N(L)OAEC= oral N(L)OAEL*(1/1.15 m3/kg/d)*(ABSoral/ABSinh.)

In according to Echa Guidance on information requirements and chemical safety assessment Chapter R.850% (instead of 100%) adsorption is assumed for oral absorption, and 100% for inhalation

AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
10
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
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:
4.17 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
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Extrapolation route to route: the dermal absorption is negligible; the  absorption from the gastrointestinal tract occurs

AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
10
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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:
0.42 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
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
10
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
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