Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
19.5 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):
8
Modified dose descriptor starting point:
NOAEC
Value:
2.44 mg/m³
Explanation for the modification of the dose descriptor starting point:
chronic dose oral
AF for dose response relationship:
1
Justification:
oral to inhalation
AF for differences in duration of exposure:
1
Justification:
chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
0.7
Justification:
5/7 days
AF for intraspecies differences:
3
Justification:
worker
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Justification:
not taken into account: granulometry with only<4 % inhalable, in ordre not to add further exposure to the natural exposure to salicylates trough Food which was estimated to a range from about 10 mg to 200 mg/day salicylate in Western diets (Swain et al., 1985, Research, 85, 950-960)
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:
4.9 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):
12
Modified dose descriptor starting point:
NOAEL
Value:
59.2 mg/kg bw/day
AF for differences in duration of exposure:
1
Justification:
chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
3
Justification:
workers also 5/7 days
AF for the quality of the whole database:
1
Justification:
human drug use
AF for remaining uncertainties:
1
Justification:
not taken into account low dermal penetration ( < 2%) in ordre not to add further exposure to the natural exposure to salicylates trough Food which was estimated to a range from about 10 mg to 200 mg/day salicylate in Western diets (Swain et al., 1985, Research, 85, 950-960)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Value:
1 180 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
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:
DNEL (Derived No Effect Level)
Value:
0.475 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
chronic
AF for differences in duration of exposure:
1
Justification:
also drug use
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
10
Justification:
human general population
AF for the quality of the whole database:
1
Justification:
human use as drug
AF for remaining uncertainties:
1
Justification:
granulometry not taken into account; only few % inhalable
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:
1.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
10
Justification:
human general population
AF for the quality of the whole database:
1
Justification:
human experience
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:
1.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
human experience: drug use
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.275 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):
40
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEL
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for intraspecies differences:
10
Justification:
general population

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Population not exposed to dust, only pills.