Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
LOAEC
Value:
105 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification to LOAEL workers: 6hr exposure rat vs 8 hr worker = 6/8 = 0.75 Respiratory volume rat vs human  = 6.7/10 = 0.67 Change ppm to mg/m3 = ppm x MW/24.45 = 50 x 102.13/24.45 = 209 mg/m3  Therefore modified LOAEL workers = 209 x 0.75 x 0.67 = 105 mg/m3

AF for dose response relationship:
3
Justification:
Using LOAEL instead of NOAEL (ECHA default)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
1
Justification:
Inhaled rat to inhaled human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
1 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL from repeat dose rat dermal 90-day study = 100 mg/kg/day

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
LOAEC
Value:
37 mg/m³
Explanation for the modification of the dose descriptor starting point:

Modification to LOAEL general population: 6 hr exposure rat vs 24 hr general population       = 4 5 day exposure rat vs 7 day general population       = 5/7 = 0.714 Change ppm to mg/m3 = ppm x MW/24.45 = 50 x 102.13/24.45 = 209 mg/m3  Therefore modified LOAEL general population = 209 x 0.714/4 = 37 mg/m3

AF for dose response relationship:
3
Justification:
Using LOAEL instead of NOAEL (ECHA default)
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
1
Justification:
Inhaled rat to inhaled human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.5 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL from repeat dose rat dermal 90-day study = 100 mg/kg/day

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
4
Justification:
Oral rat to dermal human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.175 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
35 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL from repeat dose rat oral 90-day study = 35 mg/kg/day

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA default)
AF for interspecies differences (allometric scaling):
4
Justification:
Oral rat to oral human (ECHA default)
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Similar to OECD design (ECHA default)
AF for remaining uncertainties:
1
Justification:
No remianing uncertainties (ECHA 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:
low hazard (no threshold derived)

Additional information - General Population