Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
19 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):
300
Modified dose descriptor starting point:
LOAEC
DNEL value:
5 730 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalative study available, according to Guidance on information requirements and chemical safety assessment Chapter R.8 route-to-route extrapolation is possible.
AF for dose response relationship:
6
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6 and page 29. An AF of 6 is chosen due to the fact that limited information on the dose-response curve is available (this fact increases the AF) and due to the low severity of effects (as significant effects reduced body weight) (this fact is decreasing the AF).
AF for differences in duration of exposure:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-3
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for intraspecies differences:
5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.08 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:
LOAEL
DNEL value:
325 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No long-term dermal exposure study available, according to Guidance on information requirements and chemical safety assessment Chapter R.8 route-to-route extrapolation is possible. The dermal absorption is not expected to be higher than oral absorption, therefore no AF for route-to-route Extrapolation is needed.
AF for dose response relationship:
6
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6 and page 29
AF for differences in duration of exposure:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-3
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for intraspecies differences:
5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

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:
9.55 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):
600
Modified dose descriptor starting point:
LOAEC
DNEL value:
5 730 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalative study available, according to Guidance on information requirements and chemical safety assessment Chapter R.8 route-to-route extrapolation is possible.
AF for dose response relationship:
6
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6 and page 29. An AF of 6 is chosen due to the fact that limited information on the dose-response curve is available (this fact increases the AF) and due to the low severity of effects (as significant effects reduced body weight) (this fact is decreasing the AF).
AF for differences in duration of exposure:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-3
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for intraspecies differences:
10
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.54 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:
LOAEL
DNEL value:
325 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No long-term dermal exposure study available, according to Guidance on information requirements and chemical safety assessment Chapter R.8 route-to-route extrapolation is possible. The dermal absorption is not expected to be higher than oral absorption, therefore no AF for route-to-route Extrapolation is needed.
AF for dose response relationship:
6
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6 and page 29. An AF of 6 is chosen due to the fact that limited information on the dose-response curve is available (this fact increases the AF) and due to the low severity of effects (as significant effects reduced body weight) (this fact is decreasing the AF).
AF for differences in duration of exposure:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-3
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for intraspecies differences:
10
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.54 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:
LOAEL
DNEL value:
325 mg/kg bw/day
AF for dose response relationship:
6
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6 and page 29. An AF of 6 is chosen due to the fact that limited information on the dose-response curve is available (this fact increases the AF) and due to the low severity of effects (as significant effects reduced body weight) (this fact is decreasing the AF).
AF for differences in duration of exposure:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-3
AF for other interspecies differences:
2.5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for intraspecies differences:
10
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for the quality of the whole database:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
AF for remaining uncertainties:
1
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8: Table R.8-6
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.54 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population