Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.69 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):
30
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
Value:
440.79 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health), Appendix R-8 -2, example B.3, the corrected NOAEC (inhalation) can be calculated as follow:

For workers:

Corrected NOAEC (inhalation) = NOAEL(oral)*(1/sRVrat)*(absorption oral rat/absorption inhal human)*(sRVhuman/wRV)=NOAEL(oral)*(1/0.38)*(absorption oral rat/absorption inhalation human)*(6.7/10) = 500*(1/0.38)*(0.5/1)*(6.7/10) = 440.79 mg/m3, taking into account worst case factors (absorption oral rat of 50% and absorption inhalation human of 100%) and a NOAEL(oral) of 500 mg/kg bw/d.

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
88.16 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):
5
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
Value:
440.79 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health), Appendix R-8 -2, example B.3, the corrected NOAEC (inhalation) can be calculated as follow:

For workers:

Corrected NOAEC (inhalation) = NOAEL(oral)*(1/sRVrat)*(absorption oral rat/absorption inhal human)*(sRVhuman/wRV)=NOAEL(oral)*(1/0.38)*(absorption oral rat/absorption inhalation human)*(6.7/10) = 500*(1/0.38)*(0.5/1)*(6.7/10) = 440.79 mg/m3, taking into account worst case factors (absorption oral rat of 50% and absorption inhalation human of 100%) and a NOAEL(oral) of 500 mg/kg bw/d.

AF for dose response relationship:
1
AF for intraspecies differences:
5
AF for the quality of the whole database:
1

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
264 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor starting point:
LOAEC
Value:
3 960 mg/m³
AF for dose response relationship:
3
AF for intraspecies differences:
5
AF for the quality of the whole database:
1

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.17 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):
120
Dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health), Appendix R-8 -2, example B.5, the corrected NOAEL (dermal) can be calculated as follow:

Corrected NOAEL (dermal) = NOAEL(oral) * (absorption oral rat/absorption dermal human) = 500 mg/kg bw/d, taking into account worst case factors (absorption oral rat = absorption dermal human) and a NOAEL(oral) of 500 mg/kg bw/d.

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

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

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population