Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.75 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
881.72 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
1
Justification:
AF is not used for inhalation route
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

DN(M)EL-Worker

From the available studies, a NOAEL for sub-acute repeated dose toxicity study ( (Method B7 of directive 92/69/EEC) is used as the starting point for DNEL calculations.

Dermal DN(M)EL

Starting point: NOAEL 1000 mg/kg bw/day from sub-acute repeated dose toxicity study

Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1

Corrected NOAEL: 1000mg/kg bw/day

Interspecies differences: Allometric scaling: 4

Remaining interspecies differences: 2.5

Intraspecies differences: 5

Differences in duration of exposure (sub-acute to chronic): 6

Dose response and endpoint specific/severity issues: 1

Quality of database: 1

Overall factor (product of individual factors): 300

=>Worker DNEL long-term for dermal route-systemic: 3.33mg/kg bw/day

Inhalation DN(M)EL

Starting point: NOAEL 1000 mg/kg bw/day from sub-acute repeated dose toxicity study

Respiratory volume rat (sRV) (worker (8 h): 1/0.38): 2.632

Differences in respiratory volume (default factor "light activity worker"): 0.67

Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5

=>Corrected NOAEC: 881.72 mg/m3

Interspecies differences: Allometric scaling: 1

Remaining interspecies differences: 2.5

Intraspecies differences: 5

Differences in duration of exposure (sub-acute to chronic): 6

Dose response and endpoint specific/severity issues: 1

Quality of database: 1

Overall factor (product of individual factors): 75

=>Worker DNEL long-term for inhalation route-systemic: 11.75 mg/m3

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.89 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Value:
434.8 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
1
Justification:
AF is not used for inhalation route
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
1.66 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
1.66 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

DNEL General Population                                                                               

From the available studies, a NOAEL for sub-acute repeated dose toxicity study (Method B7 of directive 92/69/EEC) is used as the starting point for DNEL calculations.

Oral DNEL

Starting point: NOAEL 1000mg/kg bw/day from sub-acute repeated dose toxicity study

Interspecies differences: Allometric scaling: 4

Remaining interspecies differences: 2.5

Intraspecies differences: 10

Differences in duration of exposure (sub-acute to chronic): 6

Dose response and endpoint specific/severity issues: 1

Quality of database: 1

Overall factor (product of individual factors): 600

=>General population DNEL long-term for oral route-systemic: 1.66 mg/kg bw/day

Dermal DNEL

Starting point: NOAEL 1000 mg/kg bw/day from oral route

Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1

Corrected NOAEL: 1000 mg/kg bw/day

Interspecies differences: Allometric scaling: 4

Remaining interspecies differences: 2.5

Intraspecies differences: 10

Differences in duration of exposure (sub-acute to chronic): 6

Dose response and endpoint specific/severity issues: 1

Quality of database: 1

Overall factor (product of individual factors): 600

=> General population DNEL long-term for dermal route-systemic: 1.66 mg/kg bw/day

Inhalation DN(M)EL

Starting point: NOAEL 1000mg/kg bw/day from oral route

Respiratory volume rat (sRV) (general population (24 h): 1/1.15): 0.8696

Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5

=>Corrected NOAEC: 434.8 mg/m3

Interspecies differences: Allometric scaling: 1

Remaining interspecies differences: 2.5

Intraspecies differences: 10

Differences in duration of exposure (sub-acute to chronic): 6

Dose response and endpoint specific/severity issues: 1

Quality of database: 1

Overall factor (product of individual factors): 150

=>General population DNEL long-term for inhalation route-systemic: 2.89 mg/m3