Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 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):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
51.1 mg/m³
Explanation for the modification of the dose descriptor starting point:
route-to- route extrapolation oral to inhalation
AF for dose response relationship:
1
Justification:
Guidance R8
AF for differences in duration of exposure:
1
Justification:
based on a 2 year chronic study (carcinogen read-across with cycloate)
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling no used for inhalation
AF for other interspecies differences:
2.5
Justification:
Guidance R8
AF for intraspecies differences:
5
Justification:
worker
AF for the quality of the whole database:
1
Justification:
Guidance R8
AF for remaining uncertainties:
1
Justification:
Guidance R8
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
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:
1.16 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):
50
Modified dose descriptor starting point:
NOAEL
Value:
58 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
route-to- route extrapolation oral to dermal
AF for dose response relationship:
1
Justification:
Guidance R8
AF for differences in duration of exposure:
1
Justification:
2 year chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
Guidance R8
AF for intraspecies differences:
5
Justification:
worker
AF for the quality of the whole database:
1
Justification:
Guidance R8
AF for remaining uncertainties:
1
Justification:
Guidance R8
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)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

H 319

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 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:
25 mg/m³
Explanation for the modification of the dose descriptor starting point:
route-to-route extrapolation from oral to inhalation
AF for dose response relationship:
1
Justification:
Guidance R8
AF for differences in duration of exposure:
1
Justification:
based on a 2 year chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling not used for inhalation
AF for other interspecies differences:
2.5
Justification:
Guidance R8
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
Guidance R8
AF for remaining uncertainties:
1
Justification:
Guidance R8
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.58 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:
58 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
route-toroute extrapolation from oral to dermal
AF for dose response relationship:
1
Justification:
Guidance R8
AF for differences in duration of exposure:
1
Justification:
based on a 2 year chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
Guidance R8
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
Guidance R8
AF for remaining uncertainties:
1
Justification:
Guidance R8
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Most sensitive endpoint:
acute toxicity
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)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.58 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:
58 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no need route-to route extrapolation from oral to oral
AF for dose response relationship:
1
Justification:
Guidance R8
AF for differences in duration of exposure:
1
Justification:
2 year chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
Guidance R8
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
Guidance R8
AF for remaining uncertainties:
1
Justification:
Guidance R8
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Value:
760 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population