Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.53 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):
75
Modified dose descriptor starting point:
NOAEC
DNEL value:
264.47 mg/m³
Explanation for the modification of the dose descriptor starting point:
Calculated using ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (see justification and comments section for more information).
AF for dose response relationship:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as the result is a threshold effect (NOAEL) from a Klimisch 1 study and no other concerns regarding the results.
AF for differences in duration of exposure:
6
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, sub-acute to chronic.
Justification:
Not required as this step has already been included during the route to route extrapolation step.
AF for other interspecies differences:
2.5
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there is no substance specific toxicokinetic information available.
AF for intraspecies differences:
5
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, workers.
AF for the quality of the whole database:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there are no issues related to completeness and consistency of the available Klimisch 1 study.
Justification:
Not applicable.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
As a worst-case assessment, and in the absence of dermal absorption data, it is assumed that all of the substance is absorbed dermally.
AF for dose response relationship:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as the result is a threshold effect (NOAEL) from a Klimisch 1 study and no other concerns regarding the results.
AF for differences in duration of exposure:
6
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, sub-acute to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health for rat to human.
AF for other interspecies differences:
2.5
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there is no substance specific toxicokinetic information available.
AF for intraspecies differences:
5
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, workers.
AF for the quality of the whole database:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there are no issues related to completeness and consistency of the available Klimisch 1 study.
Justification:
Not applicable.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Additional information - workers

Correction and assessment factors together with equations and practices used to derived the above DNEL values were taken from the ECHA guidance document "Guidance on information requirements and chemical safety assessment; Chapter R.8: Characterisation of dose [concentration]-response for human health".

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.87 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):
150
Modified dose descriptor starting point:
NOAEC
DNEL value:
130.43 mg/m³
Explanation for the modification of the dose descriptor starting point:
Calculated using ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (see justification and comments section for more information).
AF for dose response relationship:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as the result is a threshold effect (NOAEL) from a Klimisch 1 study and no other concerns regarding the results.
AF for differences in duration of exposure:
6
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as the result is a threshold effect (NOAEL) from a Klimisch 1 study and no other concerns regarding the results.
Justification:
Not required as this step has already been included during the route to route extrapolation step.
AF for other interspecies differences:
2.5
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there is no substance specific toxicokinetic information available.
AF for intraspecies differences:
10
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, general population.
AF for the quality of the whole database:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there are no issues related to completeness and consistency of the available Klimisch 1 study.
Justification:
Not applicable.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
As a worst-case assessment, and in the absence of dermal absorption data, it is assumed that all of the substance is absorbed dermally.
AF for dose response relationship:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as the result is a threshold effect (NOAEL) from a Klimisch 1 study and no other concerns regarding the results.
AF for differences in duration of exposure:
6
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, sub-acute to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health for rat to human.
AF for other interspecies differences:
2.5
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there is no substance specific toxicokinetic information available.
AF for intraspecies differences:
10
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, general population.
AF for the quality of the whole database:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there are no issues related to completeness and consistency of the available Klimisch 1 study.
Justification:
Not applicable.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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):
600
Modified dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable.
AF for dose response relationship:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as the result is a threshold effect (NOAEL) from a Klimisch 1 study and no other concerns regarding the results.
AF for differences in duration of exposure:
6
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, sub-acute to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health for rat to human.
AF for other interspecies differences:
2.5
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there is no substance specific toxicokinetic information available.
AF for intraspecies differences:
10
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, general population.
AF for the quality of the whole database:
1
Justification:
Default value from ECHAs Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health as there are no issues related to completeness and consistency of the available Klimisch 1 study.
Justification:
Not applicable.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Correction and assessment factors together with equations and practices used to derived the above DNEL values were taken from the ECHA guidance document "Guidance on information requirements and chemical safety assessment; Chapter R.8: Characterisation of dose [concentration]-response for human health".