Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.78 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):
100
Modified dose descriptor starting point:
NOAEC
DNEL value:
77.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
2
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor (rat to human), in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
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:
8.79 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
DNEL value:
879 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
2
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor (rat to human), in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
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

DNEL derivation for each of the relevant endpoints was based on the most conservative value obtained from available animal toxicity studies and the application of relevant assessment factors.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.38 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):
200
Modified dose descriptor starting point:
NOAEC
DNEL value:
76.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
2
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor (rat to human), in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
10
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
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:
4.4 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):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
879 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
2
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor (rat to human), in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
10
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
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:
0.44 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):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
87.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Undertakn as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
2
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor (rat to human), in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
10
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
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

DNEL derivation for each of the relevant endpoints was based on the most conservative value obtained from available animal toxicity studies and the application of relevant assessment factors.