Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.29 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
32.42 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
28.58 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr.= 32.42 mg/kg bw/day * (1 / (0.38 m³/kg/day)) * (0.5 / 1) * (6.7 m³ / 10 m³) = 28.58 mg/m³

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
1
Justification:
chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
remaining uncertainties
AF for intraspecies differences:
5
Justification:
worker
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
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:
0.65 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):
50
Dose descriptor starting point:
NOAEL
Value:
32.42 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
32.42 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL(corr.) = 32.42 mg/kg bw/day

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
1
Justification:
chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
worker
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
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

1. Identification of relevant dose descriptor

In an in-utero and life time study performed in rat , the substance did not cause mortalities, toxicity to reproduction and development or any adverse effects. The NOAEL is considered to be 32.42 mg/kg bw/d.

2. Mode of action

No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.

3. Application of assessment factors

Allometric scaling: rat to human = 4

Remaining uncertainties: interspecies differences = 2.5

Intraspecies factor: worker = 5, general population = 10

Exposure duration chronic to chronic: 1

Quality of data base: 1

Dose response: 1

4. Daily exposure

Worker: exposed for 8h

General population: exposed for 24h

Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.56 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):
25
Dose descriptor starting point:
NOAEL
Value:
32.42 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
14.1 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAECcorr.= 32.42 mg/kg bw/day * (1 / (1.15 m³/kg/day)) * (0.5 / 1) = 14.1 mg/m³

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
1
Justification:
chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
remaining uncertainties
AF for intraspecies differences:
10
Justification:
consumer
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
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:
0.32 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):
100
Dose descriptor starting point:
NOAEL
Value:
32.42 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
32.42 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL(corr.) = 32.42 mg/kg bw/day

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
1
Justification:
chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
remaining uncertainties
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
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:
0.32 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):
100
Dose descriptor starting point:
NOAEL
Value:
32.42 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
32.42 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
1
Justification:
chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
remaining uncertainties
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
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

1. Identification of relevant dose descriptor

In an in-utero and life time study performed in rat , the substance did not cause mortalities, toxicity to reproduction and development or any adverse effects. The NOAEL is considered to be 32.42 mg/kg bw/d.

2. Mode of action

No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.

3. Application of assessment factors

Allometric scaling: rat to human = 4

Remaining uncertainties: interspecies differences = 2.5

Intraspecies factor: worker = 5, general population = 10

Exposure duration chronic to chronic: 1

Quality of data base: 1

Dose response: 1

4. Daily exposure

Worker: exposed for 8h

General population: exposed for 24h

Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008