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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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):
25
Dose descriptor starting point:
NOAEL
Value:
667 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
823 mg/m³
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 667 mg/kg bw /day was determined for the substance in a sub-chronic repeated-dose toxicity study in rats (Hagan 1967). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/0.38 m³/kg/day, the absorption rates (oral 50 %, inhalation 100 %; in accordance with ECHA Guidance R.8 the absorption rate of the starting route is half that of the end route), the standard respiratory volume in humans/ worker respiratory volume (6.7 m³ (8 h) / 10 m³ (8 h)) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.

NOAEC corrected = 667 mg/kg bw/day * 1/0.38 m³/kg/day * 50/100 * (6.7 m³/10 m³) * 1.4 = 823 mg/m³

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling should be applied in case of oral-to-inhalation extrapolation
AF for other interspecies differences:
2.5
Justification:
default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
The quality of the database is considered to be good
AF for remaining uncertainties:
1
Justification:
default (no remaining uncertainties are identified)
Acute/short 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):
25
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEL
Value:
667 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
823 mg/m³
Explanation for the modification of the dose descriptor starting point:

The short-term hazard is covered by the long-term DNEL

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)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.34 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):
100
Dose descriptor starting point:
NOAEL
Value:
667 mg/kg bw/day
Modified dose descriptor starting point:
other: NOAEC
Value:
934 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 667 mg/kg bw /day was determined for the substance in a sub-chronic repeated-dose toxicity study in rats (Hagan 1967). This value was converted into the corrected dermal NOAEC taking into account the absorption rates (oral 100 %, dermal 100 %) and the correction factor between human and experimental exposure conditions workers (5 working days vs. 7 days continuous exposure) of 1.4.

NOAEC corrected = 667 mg/kg bw/day * 100/100 * 1.4 = 934 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
1
Justification:
The quality of the database is considered to be good.
AF for remaining uncertainties:
1
Justification:
default (no remaining uncertainties are identified)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.34 mg/kg bw/day
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEC
Value:
667 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
934 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The short-term hazard is covered by the long-term DNEL.

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:
medium 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:
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):
50
Dose descriptor starting point:
NOAEL
Value:
667 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
290 mg/m³
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 667 mg/kg bw /day was determined for the substance in a sub-chronic repeated-dose toxicity study in rats (Hagan 1967). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/1.15 m³/kg/day, the absorption rates (oral 50 %, inhalation 100 %; in accordance with ECHA Guidance R.8 the absorption rate of the starting route is half that of the end route).

NOAEC corrected = 667 mg/kg bw/day * 1/1.15 m³/kg/day * 50/100 = 290 mg/m³

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling should be applied in case of oral-to-inhalation extrapolation
AF for other interspecies differences:
2.5
Justification:
default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
1
Justification:
The quality of the database is considered to be good.
AF for remaining uncertainties:
1
Justification:
default (no remaining uncertainties are identified)
Acute/short 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):
50
Dose descriptor starting point:
NOAEL
Value:
667 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
290 mg/m³
Explanation for the modification of the dose descriptor starting point:

The short-term hazard is covered by the long-term DNEL.

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)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.34 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:
667 mg/kg bw/day
Modified dose descriptor starting point:
other: NOAEC
Value:
667 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 667 mg/kg bw /day was determined for the substance in a sub-chronic repeated-dose toxicity study in rats (Hagan 1967). This value does not have to be corrected, as the dermal and oral absorption rates are both considered to be 100 % as a worst-case assumption.

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
The quality of the database is considered to be good.
AF for remaining uncertainties:
1
Justification:
default (no remaining uncertainties are identified)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.34 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
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEL
Value:
667 mg/kg bw/day
Modified dose descriptor starting point:
other: NOAEC
Value:
667 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The short-term hazard is covered by the long term DNEL.

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)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.34 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:
667 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
667 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 667 mg/kg bw /day was determined for the substance in a sub-chronic repeated-dose toxicity study in rats (Hagan 1967). This value does not have to be corrected, as the oral absorption rates in human and rat are considered to be identical.

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default (sub-chronic to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rat
AF for other interspecies differences:
2.5
Justification:
default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
The quality of the database is considered to be good.
AF for remaining uncertainties:
1
Justification:
default (no remaining uncertainties are identified)
Acute/short 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):
200
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEL
Value:
667 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
667 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In accordance with ECHA Guidance R.8 the long-term DNEL derived based on an oral sub-chronic study in rats (Hagan, 1967) is modified by multiplying with a factor of 5 to derive the ST DNEL.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population