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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
32.9 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
2 468.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

DNEL derivation is based on a 4-week toxicity study by oral daily administration to rats (Molinier, 1996). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity.

Similar absorption rates assumed for the oral and inhalation routes.

The NAEC (8h) derived for workers is 2468.4 mg/m3 after correction for difference between respiratory rates under standard conditions and under conditions of light activity (1000 mg/kg bw / 0.38 m3/kg bw x 6.7 m3/10 m3 x 7d/5d).

AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
6
Justification:
default AF
AF for interspecies differences (allometric scaling):
1
Justification:
not needed
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
46.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
14 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL derivation is based on a 4-week toxicity study by oral administration to rats (Molinier, 1996). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity. Default absorption rates of 100 and 10% are assumed for the oral and dermal routes, respectively.

The NAEL (8h) derived for workers is 14000 mg/kg bw/d after correction for difference between skin vs oral absorption and duration of exposure (7 days vs. 5 days/week) (1000 mg/kg bw * 100/10 * 7d/5d).

AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
6
Justification:
default AF
AF for interspecies differences (allometric scaling):
4
Justification:
default AF
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.8 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
869.6
Explanation for the modification of the dose descriptor starting point:

DNEL derivation is based on a 4-week toxicity study by oral daily administration to rats (Molinier, 1996). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity.

Default absorption rate of 100 is assumed for both the oral and inhalation routes, respectively.

The NAEC (8h) derived for general population is 869.6 mg/m3 (1000 mg/kg bw / 1.15 m3/kg bw).

AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
6
Justification:
default AF
AF for interspecies differences (allometric scaling):
1
Justification:
not needed
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
10
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
16.7 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
10 000
Explanation for the modification of the dose descriptor starting point:

DNEL derivation is based on a 4-week toxicity study by oral administration to rats (Molinier, 1996). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity. Default absorption rates of 100 and 10% are assumed for the oral and dermal routes, respectively.

AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
6
Justification:
default AF
AF for interspecies differences (allometric scaling):
4
Justification:
default AF
AF for other interspecies differences:
2.4
Justification:
default AF
AF for intraspecies differences:
10
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
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:
1.7 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL derivation is based on a 4-week toxicity study by oral administration to rats (Molinier, 1996). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity. The same absorption rate by oral route is assumed for both human and rat.

AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
6
Justification:
default AF
AF for interspecies differences (allometric scaling):
4
Justification:
default AF
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
10
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
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