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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.7 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:
316 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
278.58 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the inhalation DNEL, was the oral rat NOAEL of 316 mg/kg bw/day derived from an OECD combined repeated dose toxicity study with the reproduction/developmental toxicity screening study. This dose descriptor which is the starting point was corrected for route-to-route extrapolation[i.e., NOAELoral rat ÷ SRvrat x (SRvhuman ÷ WSRvhuman) x (ABSoral-rat/ABSinh-human)] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELoral rat = 316 mg/kg bw/d; SRvrat = 0.38 m3/kg bw; SRvhuman = 6.7 m3; WSRvhuman = 10 m3; ABSoral-rat = 50%; ABSinh-human = 100% = 316 x 1/0.38 x6.7/10 x 50/100 = 278.58 mg/m3

AF for dose response relationship:
1
Justification:
Dose response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) since this is already accounted for when obtaining the corrected NOEC
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factors for workers
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional factors are required
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
134.6 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEC
Value:
2 510 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
1 682 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the acute inhalation DNEL, was the inhalation rat LC50 of 2510 mg/m3 derived from an acute inhalation study. This dose descriptor which is the starting point was corrected for the difference between respiratory rates under standard conditions and under conditions of light activity exposure conditions [i.e., LC50 rat x (SRvhuman ÷ WSRvhuman)] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: LC50 rat = 2510 mg/m3; SRvhuman = 6.7 m3; WSRvhuman = 10 m3 = 2510 x 6.7/10 = 1682 mg/m3

AF for dose response relationship:
1
Justification:
As no toxic signs were noted at the LC50/inhalation the LC50/inhalation is considered to be also the NOAEC/inhalation. A factor of 1 is therefore applied to cover the ratio of LC50/NOAEC
AF for interspecies differences (allometric scaling):
1
Justification:
Not required, as the starting dose is expressed in concentration and allometric scaling is assumed to be factored in according to the allometric principle. Further, allometric scaling is also not considered to be appropriate for acute lethal effects as these effects, which are accomplished by an immediate and intolerable level of damage to some critical homeostatic processes, are independent of caloric demand and related physiological processes which affect toxicity.
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factors for workers
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional factors are required

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:
1.1 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:
316 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
316 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The dermal absorption is considered to be generally lower as the oral absorption. As a worst case it is therefore assumed that the NOAELdermal = NOAELoral.

AF for dose response relationship:
1
Justification:
Dose response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factor for workers
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
40 mg/kg bw/day
Most sensitive endpoint:
acute 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:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The dermal absorption is considered to be generally lower as the oral absorption. As a worst case it is therefore assumed that theLD50dermal,acute = LD50oral,rat = >2000 mg/kg bw.As no toxic signs were noted at the LD50/oral the LD50/oral is considered to be also the NOAEL/oral. Therefore, NOAELdermal = NOAELoral.

AF for dose response relationship:
1
Justification:
As no toxic signs were noted at the LD50/oral the LD50/oral is considered to be also the NOAEL/oral. A factor of 1 is therefore applied to cover the ratio LD50/NOAEL.
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
5
Justification:
Assessment factor for workers
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high 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:
0.92 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:
316 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
137.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant dose descriptor selected to derive the inhalation DNEL, was the oral rat NOAEL of 316 mg/kg bw/day derived from an OECD combined repeated dose toxicity study with the reproduction/developmental toxicity screening study. This dose descriptor which is the starting point was corrected for route-to-route extrapolation[i.e., NOAELoral rat ÷ SRvrat x (ABSoral-rat/ABSinh-human)] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELoral rat = 316 mg/kg bw/d; SRvrat (for 24 hrs) = 1.15 m3/kg bw; ABSoral-rat = 50%; ABSinh-human = 100% = 316 x 1/1.15 x 50/100 = 137.39 mg/m3

AF for dose response relationship:
1
Justification:
Dose response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
1
Justification:
No assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human) since this is already accounted for when obtaining the corrected NOEC
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factors for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional factors are required
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100.4 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
2 510 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
2 510 mg/m³
Explanation for the modification of the dose descriptor starting point:

The same absorption by the inhalation route is assumed for human and rat.

AF for dose response relationship:
1
Justification:
As no toxic signs were noted at the LC50/inhalation the LC50/inhalation is considered to be also the NOAEC/inhalation. A factor of 1 is therefore applied to cover the ratio LC50/NOAEC.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required, as the starting dose is expressed in concentration and allometric scaling is assumed to be factored in according to the allometric principle. Further, allometric scaling is also not considered to be appropriate for acute lethal effects as these effects, which are accomplished by an immediate and intolerable level of damage to some critical homeostatic processes, are independent of caloric demand and related physiological processes which affect toxicity.
AF for other interspecies differences:
2.5
Justification:
Assessment factors for remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factors for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional factors are required

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:
0.5 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:
316 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
316 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The dermal absorption is considered to be generally lower as the oral absorption. As a worst case it is therefore assumed that the NOAELdermal = NOAELoral.

AF for dose response relationship:
1
Justification:
Dose response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factor for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/kg bw/day
Most sensitive endpoint:
acute 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:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The dermal absorption is considered to be generally lower as the oral absorption. As a worst case it is therefore assumed that the LD50dermal,acute = LD50oral,rat = >2000 mg/kg bw. As no toxic signs were noted at the LD50/oral the LD50/oral is considered to be also the NOAEL/oral. Therefore, NOAELdermal = NOAELoral.

AF for dose response relationship:
1
Justification:
As no toxic signs were noted at the LD50/oral the LD50/oral is considered to be also the NOAEL/oral. Therefore, NOAELdermal = NOAELoral.
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factor for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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:
316 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
316 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The same absorption by the oral route is assumed for human and rat.

AF for dose response relationship:
1
Justification:
Dose-response (starting point is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
Assessment factors for exposure duration (sub-acute to chronic study)
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factor for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/kg bw/day
Most sensitive endpoint:
acute 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:
2 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
As no toxic signs were noted at the LD50/oral the LD50/oral is considered to be also the NOAEL/oral. A factor of 1 is therefore applied to cover the ratio LD50/NOAEL.
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factor applied for interspecies difference - allometric (metabolic rate) scaling (rat-to-human)
AF for other interspecies differences:
2.5
Justification:
Assessment factor for any remaining non-metabolic differences
AF for intraspecies differences:
10
Justification:
Assessment factor for general population
AF for the quality of the whole database:
1
Justification:
Good quality study
AF for remaining uncertainties:
1
Justification:
No additional assessment factors are required

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population