Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
7.05 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):
25
Modified dose descriptor starting point:
NOAEC
176.3 mg/m³
Explanation for the modification of the dose descriptor starting point:
Dose descriptor is a NOAEL of 200 mg/kg bw/day from an oral, sub-chronic, repeated-dose toxicity study. The dose descriptor is converted to a corrected inhalation dose descriptor starting point by taking into account a factor of 0.38 for conversion of an oral dose descriptor to a worker 8 h inhalation exposure, differences in absorption rate (0.5 oral to 1 inhalation), and differences in the respiratory volume of human at rest (6.7 m³/person) compared to light activity for workers (10 m³/person) (corrected inhalation starting point = 200 / 0.38 x 0.5/1 x 6.7/10 = 176.3 mg/m³).
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic extrapolation factor
AF for interspecies differences (allometric scaling):
1
Justification:
alreqady included in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF for workers
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
2 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
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dose descriptor is a NOAEL of 200 mg/kg bw/day from an oral, sub-chronic, repeated-dose toxicity study. The oral dose descriptor is converted to a corrected dermal dose descriptor starting point without any modification required. As worst-case assumption, absorption is considered to be the same for both (oral and dermal) routes.
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic extrapolation factor
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor from rat to man
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF for worker
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

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:
no hazard identified
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:
no hazard identified
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population