Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.4 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:
374 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
330 mg/m³
Explanation for the modification of the dose descriptor starting point:

In the absence of data on absorption, it was assumed that 50% absorption occurs by the oral route.

To secure a conservative external NOAEL a maximum absorption should be assumed for the inhalation route (i.e.; 100%).

To convert the oral NOAEL into inhalatory NOAEC, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 0.38 m3/kg bw/8h).

For workers a correction was added for the difference between respiratory rates under standard conditions (sRVhuman: 6.7 m3 for an 8h exposure period) and under conditions of light activity (wRV: 10 m3 for an 8h exposure period).

Thus, the corrected starting point for inhalation is: 374 mg/kg bw/d x (1/0.38 m3/kg bw/8h) x (6.7 m3 for 8h exposure /10 m3 for 8h exposure) / 2 = 330 mg/m3 for workers.

AF for dose response relationship:
1
Justification:
Starting point is a NOAEC
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for oral to inhalation extrapolation
AF for other interspecies differences:
2.5
Justification:
Toxicodynamic and toxicokinetic remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate database
AF for remaining uncertainties:
1
Justification:
None
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:
1.25 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):
300
Dose descriptor starting point:
NOAEL
Value:
374 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
374 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No additional factor is needed when performing oral to dermal extrapolation.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling from rat to human
AF for other interspecies differences:
2.5
Justification:
Toxicodynamic and toxicokinetic remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
1
Justification:
Appropriate database
AF for remaining uncertainties:
1
Justification:
None
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.09 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:
374 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
163 mg/m³
Explanation for the modification of the dose descriptor starting point:

In the absence of data on absorption, it was assumed that 50% absorption occurs by the oral route.

To secure a conservative external NOAEL a maximum absorption should be assumed for the inhalation route (i.e.; 100%). To convert the oral NOAEL into inhalatory NOAEC, a rat default respiratory volume was used corresponding to the daily duration of human exposure (sRVrat: 1.15 m3/kg bw/d). Thus, the corrected starting point for inhalation is : 374 mg/kg bw/d x (1/1.15 m3/kg bw/d) / 2 = 163 mg/m3

AF for dose response relationship:
1
Justification:
Starting point is a NOAEC
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for oral to inhalation route extrapolation
AF for other interspecies differences:
2.5
Justification:
Toxicodynamic and toxicokinetic remaining differences
AF for intraspecies differences:
10
Justification:
Default factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate database
AF for remaining uncertainties:
1
Justification:
None
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:
0.62 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:
374 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
374 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No additional factor is needed when performing oral to dermal extrapolation
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling from rat to human
AF for other interspecies differences:
2.5
Justification:
Toxicodynamic and toxicokinetic remaining differences
AF for intraspecies differences:
10
Justification:
Default factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate database
AF for remaining uncertainties:
1
Justification:
None
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:
0.62 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:
374 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
374 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation needed.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling from rat to human
AF for other interspecies differences:
2.5
Justification:
Toxicodynamic and toxicokinetic remaining differences
AF for intraspecies differences:
10
Justification:
Default factor for general population
AF for the quality of the whole database:
1
Justification:
Appropriate database
AF for remaining uncertainties:
1
Justification:
None
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population