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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.74 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
18.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point for the DNEL derivation is the oral NOAEL of 15 mg/kg bw/day established in the developmental toxicity study in the rat. This NOAEL was modified in accordance with the ECHA guidance R.8 for the derivation of the DNEL.

AF for dose response relationship:
1
Justification:
Starting point for the DNEL derivation is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default assessment factor in case of a developmental toxicity study
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation
AF for other interspecies differences:
2.5
Justification:
Default assessment factor
AF for intraspecies differences:
5
Justification:
Default assessment factor
AF for the quality of the whole database:
1
Justification:
Reliable data on repeated dose toxicity of the substance available
AF for remaining uncertainties:
1
Justification:
Default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.21 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
21 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point for the DNEL derivation is the oral NOAEL of 15 mg/kg bw/day established in the developmental toxicity study in the rat. This NOAEL was modified in accordance with the ECHA guidance R.8 for the derivation of the DNEL.

AF for dose response relationship:
1
Justification:
Starting point for DNEL derivation is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default assessment factor in case of a developmental toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor
AF for other interspecies differences:
2.5
Justification:
Default assessment factor
AF for intraspecies differences:
5
Justification:
Default assessment factor
AF for the quality of the whole database:
1
Justification:
Reliable data on repeated dose toxicity of the substance available
AF for remaining uncertainties:
1
Justification:
Default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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

The substance is not acutely toxic following dermal exposure and does not possess irritation properties and therefore no acute dermal DNEL and no acute or long-term DNELs for local effects are required.

The substance is considered to not possess genotoxic potential and therefore the NOAEL of 15 mg/kg/day has been chosen for deriving long-term dermal and inhalation DNELs. Appropriate assessment factors from the ECHA Guidance Document "Guidance on information requirements and chemical safety assessment; Chapter R8: Characterisation of dose [concentration]-response for human health" have been applied.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.11 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
5.55 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point for the DNEL derivation is the oral NOAEL of 15 mg/kg bw/day established in the developmental toxicity study in the rat. This NOAEL was modified in accordance with the ECHA guidance R.8 for the derivation of the DNEL.

AF for dose response relationship:
1
Justification:
The starting point for the DNEL derivation is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default assessment factor in case of a developmental toxicity study.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation
AF for other interspecies differences:
2.5
Justification:
Default assessment factor
AF for intraspecies differences:
10
Justification:
Default assessment factor
AF for the quality of the whole database:
1
Justification:
Reliable data on repeated dose toxicity of the substance available
AF for remaining uncertainties:
1
Justification:
Default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.075 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point for the DNEL derivation is the oral NOAEL of 15 mg/kg bw/day established in the developmental toxicity study in the rat. This NOAEL was modified in accordance with the ECHA guidance R.8 for the derivation of the DNEL.

AF for dose response relationship:
1
Justification:
The starting point for DNEL derivation is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default assessment factor in case of a developmental toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor
AF for other interspecies differences:
2.5
Justification:
Default assessment factor
AF for intraspecies differences:
10
Justification:
Default assessment factor
AF for the quality of the whole database:
1
Justification:
Reliable data on the repeated dose toxicity are available
AF for remaining uncertainties:
1
Justification:
Default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.075 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):
200
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point for the DNEL derivation is the oral NOAEL of 15 mg/kg bw/day established in the developmental toxicity study in the rat. This NOAEL was modified in accordance with the ECHA guidance R.8 for the derivation of the DNEL.

AF for dose response relationship:
1
Justification:
The starting point for DNEL derivation is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Default assessment factor in case of a developmental toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor
AF for other interspecies differences:
2.5
Justification:
Default assessment factor
AF for intraspecies differences:
10
Justification:
Default assessment factor
AF for the quality of the whole database:
1
Justification:
Reliable data on repeated dose toxicity are available
AF for remaining uncertainties:
1
Justification:
Default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information
Overall assessment factor (AF):
100

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The same endpoints used for setting DNELs for workers have been used for calculating DNELs for the general population.