Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.8 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):
114
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for differences in duration of exposure:
2
Justification:
exposure duration default, sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling from rat to human
AF for other interspecies differences:
2.5
Justification:
inter-specific correction
AF for remaining uncertainties:
0.57
Justification:
difference in respiratory volumes
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.08 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
57
Dose descriptor starting point:
other: acute toxicity study
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
AF for interspecies differences (allometric scaling):
2.5
Justification:
inter-specific correction for meatabolic rate
AF for intraspecies differences:
5
Justification:
for worker
AF for remaining uncertainties:
0.57
Justification:
difference in respiratory volumes

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:
10 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
AF for differences in duration of exposure:
2
Justification:
exposure duration default, sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling from rat to human
AF for other interspecies differences:
2.5
Justification:
inter-specific correction for meataboli rate
AF for intraspecies differences:
5
Justification:
intra-species, worker
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
170 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
other: Acute toxicity study LD50
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
other: LD50
AF for other interspecies differences:
2.5
Justification:
default value for inter-specific effects
AF for intraspecies differences:
5
Justification:
intra-specific for worker
AF for the quality of the whole database:
1

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:
DNEL (Derived No Effect Level)
Value:
8.69 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):
115
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling from rat to human
AF for other interspecies differences:
2.5
Justification:
correction for metabolic rate
AF for intraspecies differences:
10
Justification:
inter-species, general population
AF for remaining uncertainties:
1.15
Justification:
difference in respiratory volume
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.7 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):
230
Dose descriptor starting point:
other: Acute toxicity LD50
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
AF for interspecies differences (allometric scaling):
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
intra-specific for general population

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:
2.5 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):
400
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
10
Justification:
inter-species, general population
AF for other interspecies differences:
4
Justification:
allometric scaling from rat to human
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
80 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
other: Acute toxicity LD50
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
other: acute study
AF for other interspecies differences:
2.5
Justification:
remaining inter-specific differences
AF for intraspecies differences:
10
Justification:
intra-specific for general population

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:
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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for other interspecies differences:
10
Justification:
inter-species, general population
AF for remaining uncertainties:
2.5
Justification:
correction for metabolic rate
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
80 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
other: acute study
Value:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
AF for other interspecies differences:
2.5
Justification:
remaining inter-specific differences
AF for intraspecies differences:
10
Justification:
intra-specific for general population

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population