Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
73.44 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):
18
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 322 mg/m³
AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (subacute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) since this is already accounted for when obtaining the corrected NOEC
AF for other interspecies differences:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
3
Justification:
Intraspecies variation (workers). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
4.16 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation applied
AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
1
Justification:
Exposure duration (chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
3
Justification:
Intraspecies variation (workers). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality NTP study
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low 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:
21.73 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance and ECETOC Guidance
Overall assessment factor (AF):
30
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
652 mg/m³
Explanation for the modification of the dose descriptor starting point:
Oral systemic NOAEL from subacute repeated dose toxicity test in rat.
AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (subacute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) since this is already accounted for when obtaining the corrected NOEC
AF for other interspecies differences:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
5
Justification:
Intraspecies variation (general population). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality
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:
2.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: REACH Guidance and ECETOC Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
1
Justification:
Exposure duration (chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
5
Justification:
Intraspecies variation (general population). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: REACH Guidance and ECETOC Guidance
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Exposure duration (subacute to chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
1
Justification:
Any remaining differences are of intraspecies rather than interspecies variability. Based on this, the additional assessment factor of 2.5 for inter species variability will not be used.
AF for intraspecies differences:
5
Justification:
Intraspecies variation (general population). ECETOC proposed in 2003, based on the scientific evidence, that assessment factors of 3 for workers and 5 for the general population are sufficient for covering any intraspecies variability, which includes the remaining differences factor of 2.5.
AF for the quality of the whole database:
1
Justification:
Good quality study
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population