Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
19.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance & ECETOC T110 (2010)
Overall assessment factor (AF):
10.3
Modified dose descriptor starting point:
NOAEC
Value:
1 400 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAEL(oral) = 200 mg/kg bw/day; body weight: 70 kg; 10 m3 breathing volume/working day
AF for differences in duration of exposure:
6
Justification:
Sub acute – chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat - human
AF for intraspecies differences:
3
Justification:
workers (ECETOC)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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)
Value:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC T110 (2010)
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Value:
60 mg/kg bw/day
AF for differences in duration of exposure:
6
Justification:
subactue - chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat - human
AF for intraspecies differences:
3
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

to be filled in