Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 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
Modified dose descriptor starting point:
NOAEC
DNEL value:
2.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
1.5 mg/kg x [1/0.38 x 100/100 x 6.7/10] = 2.6 mg/m3
AF for dose response relationship:
1
Justification:
None required. A clear NOAEL was derived.
AF for differences in duration of exposure:
1
Justification:
None required. The study may be considered a chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required after correcting starting point from oral to inhalation .
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences.
AF for intraspecies differences:
5
Justification:
Default factor for workers.
AF for the quality of the whole database:
2
Justification:
The full complement of reprotoxicity and genotoxicity studies needs to be completed.
AF for remaining uncertainties:
1
Justification:
None required. There were no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:
DNEL extrapolated from long-term DNEL

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:
0.06 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:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
1.5 mg/kg bw/day x [ 100/25] = 6 mg/kg bw/day
AF for dose response relationship:
1
Justification:
None required. A clear NOAEL was derived.
AF for differences in duration of exposure:
1
Justification:
None required. The study may be considered a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default extrapolation factor from rat to man.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
2
Justification:
The full complement of reprotoxicity and genotoxicity studies needs to be completed.
AF for remaining uncertainties:
1
Justification:
None required. There were no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.8 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
Explanation for the modification of the dose descriptor starting point:
DNEL extrapolated from long-term DNEL

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

An acute oral toxicity study, a chronic toxicity study and genotoxicity data are available. The material is acutely toxic (200< LD50 < 2000 mg/kg bw). A conservative chronic NOAEL was derivable from the 2 year rat study at 1.5 mg/kg bw/day. The material was not genotoxic in an in vitro chromosome aberration assay.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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