Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.8 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

- standard respiratory volume (rat) = 0.38 m³/kg/8h

- standard respiratory volume (human) = 6.7 m³/8h

- worker respiratory volume = 10 m³/8h

- absorption (oral, rat) = 50 % (default)

- absorption (inhalative, human) = 100 % (default)

--> modified dose descriptor (corrected inhalatory NOAEC) = oral NOAEL/0.38 x (50/100) x (6.7/10)

AF for dose response relationship:
1
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for differences in duration of exposure:
6
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for interspecies differences (allometric scaling):
1
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for other interspecies differences:
2.5
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for intraspecies differences:
5
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for the quality of the whole database:
1
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for remaining uncertainties:
1
Justification:
according to ECHA 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:
3.3 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:
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:

- route-to-route-extrapolation: factor 1

AF for dose response relationship:
1
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for differences in duration of exposure:
6
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for interspecies differences (allometric scaling):
4
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for other interspecies differences:
2.5
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for intraspecies differences:
5
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for the quality of the whole database:
1
Justification:
according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for remaining uncertainties:
1
Justification:
according to ECHA 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

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:
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

General Population - Hazard via dermal 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:
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

General Population - Hazard via oral 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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population