Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.549 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
41.2 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAEC corr = inhalatory NOAEC * (6h per day / 8h per day) * (6.7 m3 (8h) /10m3 (8h)) (cf. ECHA guidance R8.4.2). => NOAEC corr = 82 * (6/8) * (6.7/10) = 41.2 mg/m3
AF for dose response relationship:
1
Justification:
NOAEC used a starting point
AF for differences in duration of exposure:
6
Justification:
Subacute (OECD 412 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling used in derivation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Standard factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.36 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
225
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
LOAEC used a starting point
AF for differences in duration of exposure:
6
Justification:
Subacute (OECD 412 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling used in derivation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Standard factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
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:
1.057 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
317.05 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
In the absence of data on absorption via the dermal route, a default factor of 1 is applied as recommended by ECHA R8 guidance (dermal absorption is assumed not to be higher than oral absorption).
AF for dose response relationship:
1
Justification:
NOAEL used as starting point
AF for differences in duration of exposure:
6
Justification:
Subacute (equivalent to OECD 407 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor for rat to human extrapolation
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
Standard factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
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:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.137 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Value:
20.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAEC corr = inhalatory NOAEC*(6h perday /24 h per day) (cf. ECHA guidance R8.4.2). => NOAEC corr = 82 * (6/24) = 20.5 mg/m3
AF for dose response relationship:
1
Justification:
NOAEC used a starting point
AF for differences in duration of exposure:
6
Justification:
Subacute (OECD 412 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling used in derivation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
Standard factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.18 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
450
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
LOAEC used a starting point
AF for differences in duration of exposure:
6
Justification:
Subacute (OECD 412 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling used in derivation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
Standard factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
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:
0.528 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
317.05 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
In the absence of data on absorption via the dermal route, a default factor of 1 is applied as recommended by ECHA R8 guidance (dermal absorption is assumed not to be higher than oral absorption).
AF for dose response relationship:
1
Justification:
NOAEL used as starting point
AF for differences in duration of exposure:
6
Justification:
Subacute (equivalent to OECD 407 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor for rat to human extrapolation
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
Standard factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
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:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.528 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
317.05 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor is needed since it was determined in an oral toxicity study.
AF for dose response relationship:
1
Justification:
NOAEL used as starting point
AF for differences in duration of exposure:
6
Justification:
Subacute (equivalent to OECD 407 study) to chronic duration extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor for rat to human extrapolation
AF for other interspecies differences:
2.5
Justification:
Standard factor for remaining interspecies differences
AF for intraspecies differences:
10
Justification:
Standard factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population