Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70.53 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
Value:
1 763.16 mg/m³
Explanation for the modification of the dose descriptor starting point:
Exposure data only available from oral exposure.
AF for dose response relationship:
1
Justification:
Table R8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic. Table R8-6
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is accounted for in NOAEL extrapolation
AF for intraspecies differences:
5
Justification:
workers. Table R8-6
AF for the quality of the whole database:
1
Justification:
data reliable. Table R8-6
AF for remaining uncertainties:
2.5
Justification:
Table R8-6
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 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
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Exposure data only available from oral exposure.
AF for dose response relationship:
1
Justification:
Table R8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic. Table R8-6
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human. Table R8-3
AF for intraspecies differences:
5
Justification:
workers. Table R8-6
AF for the quality of the whole database:
1
Justification:
data reliable. Table R8-6
AF for remaining uncertainties:
2.5
Justification:
Table R8-6
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Dermal NOAEL

Corrected dermal (oral -> dermal)

Based on Appendix R. 8-2, Example B.5, as a worst case it is assumed that 100% adsorption orally to rats and by dermal adsorption to human are equivalent.

NOAEL (dermal) = oral NOAEL * ABS oral-rat/ABS derm-human

NOAEL (dermal) = 1000 * 100/100 = 1000

NOAEL (dermal) = 1000 mg/kg/day.

 

Inhalation NOAEL

Based on formulae in R. 8-3, as a worst case it is assumed 100% adsorption orally to rats and by inhalation to human are equivalent. The granulometry data for this substance indicates that the substance is not respirable by humans; the vapour pressure of the substance is extremely low indicating the substance is non-volatile. Target endpoints are also assumed to be equivalent.

 

For workers (8h exposure/d)

NOAEC (inhal) = oral NOAEL * 1/0.38m3/kg/d * ABS oral-rat/ABS inh-human * 6.7m3/10m3

NOAEC (inhal) = 1000 * 1/0.38 m3/kg/d * 100/100 * 6.7m3/10m3= 1763.16

NOAEC (inhal) = 1763.16 mg/m3

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.39 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):
50
Modified dose descriptor starting point:
NOAEC
Value:
869.57 mg/m³
Explanation for the modification of the dose descriptor starting point:
Exposure data only available from oral exposure
AF for dose response relationship:
1
Justification:
Table R8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic. Table R8-6
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is accounted for in NOAEL extrapolation
AF for intraspecies differences:
10
Justification:
general population. Table R8-6
AF for the quality of the whole database:
1
Justification:
data reliable. Table R8-6
AF for remaining uncertainties:
2.5
Justification:
Table R8-6
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:
5 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
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Exposure data only available from oral exposure.
AF for dose response relationship:
1
Justification:
Table R8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic. Table R8-6
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human. Table R8-3
AF for intraspecies differences:
10
Justification:
general population. Table R8-6
AF for the quality of the whole database:
1
Justification:
data reliable. Table R8-6
AF for remaining uncertainties:
2.5
Justification:
Table R8-6
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:
5 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Table R8-6
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic. Table R8-6
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human. Table R8-3
AF for intraspecies differences:
10
Justification:
general population. Table R8-6
AF for the quality of the whole database:
1
Justification:
data reliable. Table R8-6
AF for remaining uncertainties:
2.5
Justification:
Table R8-6
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

Dermal NOAEL

Corrected dermal (oral -> dermal)

Based on Appendix R. 8-2, Example B.5, as a worst case it is assumed that 100% adsorption orally to rats and by dermal adsorption to human are equivalent.

NOAEL (dermal) = oral NOAEL * ABS oral-rat/ABS derm-human

NOAEL (dermal) = 1000 * 100/100 = 1000

NOAEL (dermal) = 1000 mg/kg/day.

 

Inhalation NOAEL

Based on formulae in R. 8-3, as a worst case it is assumed 100% adsorption orally to rats and by inhalation to human are equivalent. The granulometry data for this substance indicates that the substance is not respirable by humans; the vapour pressure of the substance is extremely low indicating the substance is non-volatile. Target endpoints are also assumed to be equivalent.

 

For general population (24h exposure/d)

NOAEC (inhal) = oral NOAEL * 1/1.15m3/kg/d * ABS oral-rat/ABS inh-human

NOAEC (inhal) = 1000 * 1/1.15 m3/kg/d * 100/100 = 869.57

NOAEC (inhal) = 869.57 mg/m3