Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.001 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):
285
Modified dose descriptor starting point:
LOAEC
Value:
0.053 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation data
AF for differences in duration of exposure:
0.7
Justification:
Calorific demand during light activity, ECHA guidance
AF for interspecies differences (allometric scaling):
0.4
Justification:
Rat to human, ECHA guidance
AF for intraspecies differences:
5
Justification:
Variation between workers, ECHA guidance
AF for remaining uncertainties:
10
Justification:
Use of a LOAEL, ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.002 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
0.7 mg/kg bw/day
AF for differences in duration of exposure:
6
Justification:
use of sub-acute NOAEL
AF for other interspecies differences:
10
Justification:
ECHA guidance
AF for intraspecies differences:
5
Justification:
ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.001 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
NOAEL
Value:
0.7 mg/kg bw/day
AF for other interspecies differences:
10
Justification:
ECHA guidance
AF for intraspecies differences:
5
Justification:
ECHA guidance
AF for remaining uncertainties:
21
Justification:
To give one day response

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)

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 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
LOAEC
Value:
0.02 mg/m³
Explanation for the modification of the dose descriptor starting point:
Due to the absence of repeat-dose inhalation studies, route-to-route extrapolation using oral data have been applied, in accordance with ECHA guidance.
AF for interspecies differences (allometric scaling):
1.2
AF for intraspecies differences:
10
AF for remaining uncertainties:
10
Justification:
Use of a LOAEL
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:
0.001 mg/kg bw/day
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
0.7 mg/kg bw/day
AF for differences in duration of exposure:
6
AF for other interspecies differences:
10
AF for intraspecies differences:
10
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 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):
1 000
Modified dose descriptor starting point:
NOAEL
Value:
0.2 mg/kg bw/day
AF for other interspecies differences:
10
Justification:
ECHA guidance
AF for intraspecies differences:
10
Justification:
ECHA guidance
AF for remaining uncertainties:
10
Justification:
Use of a LOAEL, ECHA guidance
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