Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.5 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):
75
Modified dose descriptor starting point:
NOAEC
DNEL value:
1 763.16 mg/m³
Explanation for the modification of the dose descriptor starting point:
No data are available to evaluate the inhalation toxicity. According to column 2 part 8.5.2 "testing by the inhalation route is appropriate if exposure of humans via inhalation is likely to occur, taking into account the vapor pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The test substance is a liquid. Furthermore, based on ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.14: Occupational exposure estimation", Table R.14-4, the "medium vapor pressure" regarding fugacity and dustiness is being defined as the vapor pressure range 0.5 to 10 kPa. The vapor pressure value for carbohydrates and sugars, hexitols, anhydro was determined with the static method to be 1223.6 at 20°C. It is consider to be of medium fugacity according to ECHA guidance documents. According to oral and dermal acute toxicity data available a route to route extrapolation can be done in order to evaluate the acute inhalation toxicity of test substance and no toxic effect are expected.
AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
default value for extrapolation to inhalation route (example B3 of guidance R8)
AF for other interspecies differences:
2.5
Justification:
R8 ECHA guidance
AF for intraspecies differences:
5
Justification:
default value for workers
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
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:
13.3 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):
75
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The route extrapolation from oral to dermal with bioavailability is considered by default to be 100% for both routes.
AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
default value fro extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
extrapolation from oral to dermal route (example B3 of guidance R8)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value for worker
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
default value
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.79 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):
150
Modified dose descriptor starting point:
NOAEC
DNEL value:
869.56 mg/m³
Explanation for the modification of the dose descriptor starting point:
No data are available to evaluate the inhalation toxicity. According to column 2 part 8.5.2 "testing by the inhalation route is appropriate if exposure of humans via inhalation is likely to occur, taking into account the vapor pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The test substance is a liquid. Furthermore, based on ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.14: Occupational exposure estimation", Table R.14-4, the "medium vapor pressure" regarding fugacity and dustiness is being defined as the vapor pressure range 0.5 to 10 kPa. The vapor pressure value for carbohydrates and sugars, hexitols, anhydro was determined with the static method to be 1223.6 at 20°C. It is consider to be of medium fugacity according to ECHA guidance documents. According to oral and dermal acute toxicity data available a route to route extrapolation can be done in order to evaluate the acute inhalation toxicity of test substance and no toxic effect are expected.
AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
extrapolation from oral to inhalation route (example B3 of guidance R8)
AF for other interspecies differences:
2.5
Justification:
R8 ECHA guidance
AF for intraspecies differences:
10
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
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:
6.66 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):
150
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The route extrapolation from oral to dermal with bioavailability is considered by default to be 100% for both routes.
AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
default value for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
extrapolation from ral to dermal route (example B3 of guidance R8)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value general population
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
default value
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:
1.66 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
default value fro extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
extrapolation from oral to inhalation route (example B2 of guidance R8)
AF for other interspecies differences:
2.5
Justification:
R8 ECHA guidance
AF for intraspecies differences:
10
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
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