Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.99 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
78 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
137.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL(oral) was converted into a NOAEC(inhalation) using the equation described in Example R. 8 -2 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.8: Characterisation of dose [concentration]-response for human healthcare. Absorption via the oral route for rat is 100 % and via the inhalation route for humans is assumed to be 100 % as worse case.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Dose descriptor starting point is a chronic oral study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
3.12 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):
50
Dose descriptor starting point:
NOAEL
Value:
78 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
156 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal absorption estimated conservatively at 50%. Oral absorption is 100%.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Dose descriptor starting point is a chronic oral study
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
2.71 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):
25
Dose descriptor starting point:
NOAEL
Value:
78 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
67.83 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL(oral) was converted into a NOAEC(inhalation) using the equation described in Example R. 8-1 of the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.8: Characterisation of dose [concentration]-response for human healthcare. Absorption via the oral route for rat is 100 % and via the inhalation route for humans is assumed to be 100 % as worse case.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Dose descriptor starting point is a chronic oral study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
1.56 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
Dose descriptor starting point:
NOAEL
Value:
78 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
156 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal absorption estimated conservatively at 50%. Oral absorption is 100%.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Dose descriptor starting point is a chronic oral study
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
0.78 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
Dose descriptor starting point:
NOAEL
Value:
78 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
NOAEL from a chronic study
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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