Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.92 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
62.5
Modified dose descriptor starting point:
NOAEC
DNEL value:
120 mg/m³
Explanation for the modification of the dose descriptor starting point:
See ECHA Guidance
AF for differences in duration of exposure:
5
Justification:
45d study
AF for interspecies differences (allometric scaling):
1
Justification:
not relevant for inhalation
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
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:
0.544 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
250
Modified dose descriptor starting point:
NOAEL
DNEL value:
136 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See ECHA Guidance
AF for differences in duration of exposure:
5
Justification:
45d study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
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:
0.473 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
125
Modified dose descriptor starting point:
NOAEC
DNEL value:
59 mg/m³
Explanation for the modification of the dose descriptor starting point:
See ECHA Guidance
AF for differences in duration of exposure:
5
Justification:
45d
AF for interspecies differences (allometric scaling):
1
Justification:
not used for inhalation
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
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:
0.272 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
500
Modified dose descriptor starting point:
NOAEL
DNEL value:
136 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See ECHA Guidance
AF for differences in duration of exposure:
5
Justification:
45d
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
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:
0.272 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):
500
Modified dose descriptor starting point:
NOAEL
DNEL value:
136 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See ECHA Guidance
AF for differences in duration of exposure:
5
Justification:
45d
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
general population
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

The long-term DNELs (systemic effects) for the general population are

DNEL oral                     0.272 mg/kg/day

DNEL dermal                 0.272 mg/kg/day

DNEL inhalation              0.473 mg/m3

The long-term DNELs (systemic effects) for workers are

DNEL dermal                      0.544 mg/kg/day

DNEL inhalation                1.92 mg/m3