Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.14 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):
10
Dose descriptor starting point:
NOAEL
Value:
24.3 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
21.4 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)=24.3*(1/0.38)*(0.5/1)*(6.7/10) = 21.4 mg/m3, taking into account worst case factors (absorption oral rat of 50% and absorption inhalation human of 100%) and a NOAEL(oral) of 24.3 mg/kg bw/d.

AF for dose response relationship:
1
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
2
Justification:
NOAEL based on read-accross
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.14 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):
10
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEL
Value:
24.3 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
21.4 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)= 24.3*(1/0.38)*(0.5/1)*(6.7/10) = 21.4 mg/m3, taking into account worst case factors (absorption oral rat of 50% and absorption inhalation human of 100%) and a NOAEL(oral) of 24.3 mg/kg bw/d.

AF for dose response relationship:
1
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
2
Justification:
NOAEL based on read-accross

Local effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (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:
0.6 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
Dose descriptor starting point:
NOAEL
Value:
24.3 mg/kg bw/day
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) = 24.3 * (1/1) = 24.3 mg/kg bw/d, taking into account worst case factors (absorption oral rat = absorption dermal human) and a NOAEL(oral) of 24.3 mg/kg bw/d.

AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
4
Justification:
NOAEL obtained in a study carried out on rats
AF for intraspecies differences:
5
Justification:
worker population
AF for the quality of the whole database:
2
Justification:
NOAEL based on read-accross
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
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:
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:
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