Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
158 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):
10
Modified dose descriptor starting point:
NOAEC
DNEL value:
1 586 mg/m³
Explanation for the modification of the dose descriptor starting point:
only study for oral route available
AF for dose response relationship:
1
Justification:
starting point NOAEC
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
1
Justification:
AF not used, remaining differences in toxicolocial effects are not expected
AF for intraspecies differences:
5
Justification:
AF for workers
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:
225 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):
40
Modified dose descriptor starting point:
NOAEL
DNEL value:
9 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
starting point NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
4
Justification:
test animal: rat
AF for other interspecies differences:
1
Justification:
AF not used, remaining differences in toxicolocial effects are not expected
AF for intraspecies differences:
5
Justification:
AF for 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

As an acute toxicity hazard leading to Classification and Labelling of the substance has not been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur (in accordance with ECHA Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health, May 2008 and Part B: Hazard Assessment, December 2011).

Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).

Absorption oral (rat) = Absorption oral (human) = 100%

Absorption dermal (human) = 10%

Absorption inhalation (human) = 100%

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
39 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):
20
Modified dose descriptor starting point:
NOAEC
DNEL value:
782 mg/m³
AF for dose response relationship:
1
Justification:
starting point NOAEC
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
1
Justification:
AF not used, remaining differences in toxicolocial effects are not expected
AF for intraspecies differences:
10
Justification:
AF for 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:
112.5 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):
80
Modified dose descriptor starting point:
NOAEL
DNEL value:
9 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
starting point NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
4
Justification:
test animal: rat
AF for other interspecies differences:
1
Justification:
AF not used, remaining differences in toxicolocial effects are not expected
AF for intraspecies differences:
10
Justification:
AF for 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:
11.25 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):
80
Modified dose descriptor starting point:
NOAEL
DNEL value:
900 mg/kg bw/day
AF for dose response relationship:
1
Justification:
starting point NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
4
Justification:
test animal: rat
AF for other interspecies differences:
1
Justification:
AF not used, remaining differences in toxicolocial effects are not expected
AF for intraspecies differences:
10
Justification:
AF for 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

As any acute toxicity hazard leading to Classification and Labelling of the substance has not been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur (in accordance with ECHA Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health, May 2008 and Part B: Hazard Assessment, December 2011).

Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).

Absorption oral (rat) = Absorption oral (human) = 100%

Absorption dermal (human) = 10%

Absorption inhalation (human) = 100%