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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.5 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:
42.6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
37.55 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEC = NOAEL oral * (1/SRVrat) * (sRVhuman/wRV)*(ABS oral-rat /ABS inh-human) = 42.6*1/0.38*0.67*0.5 = 37.55 mg/m3  

sRV human = standard respiratory volume human= 6.7 m3 (8h)

wRV = worker respiratory volume =10 m3 (8h)

sRVrat = standard respiratory volume rat = 0.38 m3/kg/d

ABS = Absorption

Oral default absorption rate: 100% (50% if oral-to-inhalation extrapolation)

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
for extrapolation subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
default value systemic effect for extrapolation oral to inhalation
AF for other interspecies differences:
2.5
Justification:
default value systemic effect or for effects on skin, eye and GI tract via local metabolism, for effects on respiratory tract
AF for intraspecies differences:
5
Justification:
default value worker
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.17 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:
42.6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
117.35 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL was set at 42.6 mg/kg bw/day by oral route in rat during 90 days.

Absorption oral versus dermal are calculated, taking into account the maximal dermal penetration rate of 36.3% observed in in vivo study OECDE 417, on rat.

Oral absorption is assumed to be 100%

NOAEL dermal = 42.6 mg/kg bw/d x (100/36.3) = 117.35 mg/kg bw/d

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
For extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric value (rat)
AF for other interspecies differences:
2.5
Justification:
default value systemic effect or for effects on skin, eye and GI tract via local metabolism, for effects on
respiratory tract
AF for intraspecies differences:
5
Justification:
default value worker
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.66 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Dose descriptor:
other: EC3
Value:
362.5 µg/m³
AF for dose response relationship:
3
Justification:
the EC3 is considered as a LOAEL
AF for differences in duration of exposure:
1
Justification:
default value
AF for interspecies differences (allometric scaling):
1
Justification:
default value - local effects are independent of the basal metabolic rate, allometric scaling should not
be applied (allometric scaling factor of 1)
AF for other interspecies differences:
2.5
Justification:
worst case: animals and humans may respond in different way.
AF for intraspecies differences:
5
Justification:
default value for worker
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.66 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Dose descriptor starting point:
other: EC3
Value:
362.5 µg/m³
AF for dose response relationship:
1
Justification:
default value
AF for interspecies differences (allometric scaling):
1
Justification:
default value - local effects are independent of the basal metabolic rate, allometric scaling should not
be applied (allometric scaling factor of 1)
AF for other interspecies differences:
2.5
Justification:
worst case: animals and humans may respond in different way.
AF for intraspecies differences:
5
Justification:
default value for worker
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned

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:
0.37 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:
42.6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
18.52 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL was set at 42.6 mg/kg bw/day ( (90 days oral study).

NOAEC (dose descriptor calculation).

NOAEL oral * (1/SRVrat) * (ABS oral-rat/ABS inh-human)= NOAEL oral*1/1.15*(50/100) = 42.6*1/1.15*0.5= 18.52 mg/m3

Oral rat default absorption rate: 100% (50% if oral-to-inhalation extrapolation)

Inhalation human default absorption rate : 100%

sRVrat = standard respiratory volume rat = 1.15 m3/kg/d

ABS = Absorption

Oral default absorption rate: 100% (50% if oral-to-inhalation extrapolation)

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
for extrapolation subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
default value systemic effect for extrapolation oral to inhalation
AF for other interspecies differences:
2.5
Justification:
default value systemic effect or for effects on skin, eye and GI tract via local metabolism, for effects on
respiratory tract
AF for intraspecies differences:
10
Justification:
default value general population
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.59 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:
42.6 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
117.35 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL was set at 42.6 mg/kg bw/day by oral route in rat during 90 days.

Absorption oral versus dermal are calculated, taking into account the maximal dermal penetration rate

of 36.3% observed in in vivo study OECD 417, on rat.

Oral absorption is assumed to be 100%

NOAEL dermal = 42.6 mg/kg bw/d x (100/36.3) = 117.35 mg/kg bw/d

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
For extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric value (rat)
AF for other interspecies differences:
2.5
Justification:
default value systemic effect or for effects on skin, eye and GI tract via local metabolism, for effects on respiratory tract
AF for intraspecies differences:
10
Justification:
default value general population
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.83 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor:
other: EC3
Value:
362.5 µg/m³
AF for dose response relationship:
3
Justification:
the EC3 is considered as a LOAEL
AF for differences in duration of exposure:
1
Justification:
default value
AF for interspecies differences (allometric scaling):
1
Justification:
default value - local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1)
AF for other interspecies differences:
2.5
Justification:
worst case: animals and humans may respond in different way.
AF for intraspecies differences:
10
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.83 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
other: EC3
Value:
362.5 µg/m³
AF for dose response relationship:
3
Justification:
the EC3 is considered as a LOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
default value
AF for other interspecies differences:
2.5
Justification:
worst case: animals and humans may respond in different way.
AF for intraspecies differences:
10
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.213 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:
42.6 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default value4
AF for differences in duration of exposure:
2
Justification:
For extrapolation from subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric value (rat)
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
10
Justification:
default value genearl population
AF for the quality of the whole database:
1
Justification:
reliability 1
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population