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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
8.82 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:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
661.18 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation has been usesd to determine the inhalation NOAEC from a starting dose descriptor oral NOAEL, in accordance with the ECHA REACH guidance:

Inhalation NOAEC = oral NOAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.)

AF for dose response relationship:
1
Justification:
A NOAEL of 750 mg/kg bw/d has been used as the starting point for DNEL derivation. Default AF used.
AF for differences in duration of exposure:
6
Justification:
The exposure duration of the test from which the dose descriptor is taken, subacute 28-d to chronic. Default AF used.
AF for interspecies differences (allometric scaling):
1
Justification:
In accordance with the ECHA REACH guidance, for inhalation, allometric scaling is usually not appplied.
AF for other interspecies differences:
2.5
Justification:
To take into account the interspecies differences an assessment factor for remaining differences should be used . Default AF used.
AF for intraspecies differences:
5
Justification:
To take into account intraspecies variations for DNELs for workers, the assessment factor is 5. Default AF used.
AF for the quality of the whole database:
1
Justification:
The subacute toxicity study via the oral route was conducted in accordance with GLP and OECD guideline 407, therefore has been assigned a reliability score of 1.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.82 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor:
NOAEC
Value:
661.18 mg/m³
AF for dose response relationship:
1
Justification:
A NOAEL of 750 mg/kg bw/d has been used as the starting point for DNEL derivation. Default AF used.
AF for differences in duration of exposure:
6
Justification:
The exposure duration of the test from which the dose descriptor is taken, subacute 28-d to chronic. Default AF used.
AF for interspecies differences (allometric scaling):
1
Justification:
In accordance with the ECHA REACH guidance, no allometric scaling default value is provided.
AF for other interspecies differences:
2.5
Justification:
To take into account the interspecies differences an assessment factor for remaining differences should be used . Default AF used.
AF for intraspecies differences:
5
Justification:
To take into account intraspecies variations for DNELs for workers, the assessment factor is 5. Default AF used.
AF for the quality of the whole database:
1
Justification:
The subacute toxicity study via the oral route was conducted in accordance with GLP and OECD guideline 407, therefore has been assigned a reliability score of 1.
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:
2.5 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):
300
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation, oral to dermal, dermal NOAEC = oral NOAEL*(ABSoral/ ABSdermal). It has been assumed that the dermal adsorption is the same as the oral adsorption. Therefore, the dermal NOAEL is the same as the oral NOAEL, 750 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
A NOAEL of 750 mg/kg bw/d has been used as the starting point for DNEL derivation. Default AF used.
AF for differences in duration of exposure:
6
Justification:
The exposure duration of the test from which the dose descriptor is taken, subacute 28-d to chronic. Default AF used.
AF for interspecies differences (allometric scaling):
4
Justification:
The subacute toxicity study via the oral route was conducted using rats. Default AF used.
AF for other interspecies differences:
2.5
Justification:
To take into account the interspecies differences an assessment factor for remaining differences should be used . Default AF used.
AF for intraspecies differences:
5
Justification:
To take into account intraspecies variations for DNELs for workers, the assessment factor is 5. Default AF used.
AF for the quality of the whole database:
1
Justification:
The subacute toxicity study via the oral route was conducted in accordance with GLP and OECD guideline 407, therefore has been assigned a reliability score of 1.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor:
NOAEC
Value:
750 mg/m³
AF for dose response relationship:
1
Justification:
A NOAEL of 750 mg/kg bw/d has been used as the starting point for DNEL derivation. Default AF used.
AF for differences in duration of exposure:
6
Justification:
The exposure duration of the test from which the dose descriptor is taken, subacute 28-d to chronic. Default AF used.
AF for interspecies differences (allometric scaling):
1
Justification:
In accordance with the ECHA REACH guidance, no allometric scaling default value is provided.
AF for other interspecies differences:
2.5
Justification:
To take into account the interspecies differences an assessment factor for remaining differences should be used . Default AF used.
AF for intraspecies differences:
5
Justification:
To take into account intraspecies variations for DNELs for workers, the assessment factor is 5. Default AF used.
AF for the quality of the whole database:
1
Justification:
The subacute toxicity study via the oral route was conducted in accordance with GLP and OECD guideline 407, therefore has been assigned a reliability score of 1.
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:
2.17 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:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
326.09 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation has been usesd to determine the inhalation NOAEC from a starting dose descriptor oral NOAEL, in accordance with the ECHA REACH guidance:

Inhalation NOAEC = oral NOAEL*(1/1.15 m3/kg/d)*(ABSoral/ABSinh.)

AF for dose response relationship:
1
Justification:
A NOAEL of 750 mg/kg bw/d has been used as the starting point for DNEL derivation. Default AF used.
AF for differences in duration of exposure:
6
Justification:
The exposure duration of the test from which the dose descriptor is taken, subacute 28-d to chronic. Default AF used.
AF for interspecies differences (allometric scaling):
1
Justification:
In accordance with the ECHA REACH guidance, for inhalation, allometric scaling is usually not appplied.
AF for other interspecies differences:
2.5
Justification:
To take into account the interspecies differences an assessment factor for remaining differences should be used . Default AF used.
AF for intraspecies differences:
10
Justification:
To take into account intraspecies variations for DNELs for the general population, the assessment factor is 10. Default AF used.
AF for the quality of the whole database:
1
Justification:
The subacute toxicity study via the oral route was conducted in accordance with GLP and OECD guideline 407, therefore has been assigned a reliability score of 1.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.17 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
Value:
326.09 mg/m³
AF for dose response relationship:
1
Justification:
A NOAEL of 750 mg/kg bw/d has been used as the starting point for DNEL derivation. Default AF used.
AF for differences in duration of exposure:
6
Justification:
The exposure duration of the test from which the dose descriptor is taken, subacute 28-d to chronic. Default AF used.
AF for interspecies differences (allometric scaling):
1
Justification:
In accordance with the ECHA REACH guidance, no allometric scaling default value is provided.
AF for other interspecies differences:
2.5
Justification:
To take into account the interspecies differences an assessment factor for remaining differences should be used . Default AF used.
AF for intraspecies differences:
10
Justification:
To take into account intraspecies variations for DNELs for the general population, the assessment factor is 10. Default AF used.
AF for the quality of the whole database:
1
Justification:
The subacute toxicity study via the oral route was conducted in accordance with GLP and OECD guideline 407, therefore has been assigned a reliability score of 1.
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:
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):
600
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route-to-route extrapolation, oral to dermal, dermal NOAEC = oral NOAEL*(ABSoral/ ABSdermal). It has been assumed that the dermal adsorption is the same as the oral adsorption. Therefore, the dermal NOAEL is the same as the oral NOAEL, 750 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
A NOEAL of 750 mg/kg bw/d has been used as the starting point for DNEL derivation. Default AF used.
AF for differences in duration of exposure:
6
Justification:
The exposure duration of the test from which the dose descriptor is taken, subacute 28-d to chronic. Default AF used.
AF for interspecies differences (allometric scaling):
4
Justification:
The subacute toxicity study via the oral route was conducted using rats. Default AF used.
AF for other interspecies differences:
2.5
Justification:
To take into account the intersdpecies differences an assessment factor for remaining differences should be used . Default AF used.
AF for intraspecies differences:
10
Justification:
To take into account intraspecies variations for DNELs for the general population, the assessment factor is 10. Default AF used.
AF for the quality of the whole database:
1
Justification:
The subacute toxicity study via the oral route was conducted in accordance with GLP and OECD guideline 407, therefore has been assigned a reliability score of 1.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
Value:
750 mg/m³
AF for dose response relationship:
1
Justification:
A NOEAL of 750 mg/kg bw/d has been used as the starting point for DNEL derivation. Default AF used.
AF for differences in duration of exposure:
6
Justification:
The exposure duration of the test from which the dose descriptor is taken, subacute 28-d to chronic. Default AF used.
AF for interspecies differences (allometric scaling):
1
Justification:
In accordance with the ECHA REACH guidance, no allometric scaling default value is provided.
AF for other interspecies differences:
2.5
Justification:
To take into account the intersdpecies differences an assessment factor for remaining differences should be used . Default AF used.
AF for intraspecies differences:
10
Justification:
To take into account intraspecies variations for DNELs for the general population, the assessment factor is 10. Default AF used.
AF for the quality of the whole database:
1
Justification:
The subacute toxicity study via the oral route was conducted in accordance with GLP and OECD guideline 407, therefore has been assigned a reliability score of 1.
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:
1.25 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):
600
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
AF for dose response relationship:
1
Justification:
A NOEAL of 750 mg/kg bw/d has been used as the starting point for DNEL derivation. Default AF used.
AF for differences in duration of exposure:
6
Justification:
The exposure duration of the test from which the dose descriptor is taken, subacute 28-d to chronic. Default AF used.
AF for interspecies differences (allometric scaling):
4
Justification:
The subacute toxicity study via the oral route was conducted using rats. Default AF used.
AF for other interspecies differences:
2.5
Justification:
To take into account the intersdpecies differences an assessment factor for remaining differences should be used . Default AF used.
AF for intraspecies differences:
10
Justification:
To take into account intraspecies variations for DNELs for the general population, the assessment factor is 10. Default AF used.
AF for the quality of the whole database:
1
Justification:
The subacute toxicity study via the oral route was conducted in accordance with GLP and OECD guideline 407, therefore has been assigned a reliability score of 1.
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