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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.658 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):
37.5
Dose descriptor starting point:
NOAEC
Value:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
24.684 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point correction formula:

Corrected dose descriptor = oral NOAEL x 1/sRVan x Diff. exp. cond. x (ABSoral,an/ABSinh,hu) x sRVhu/wRV              

Given:

Experimental animal: rat    

Relevant human exposure route: inhalation

Oral NOAEL from original study (oral NOAEL) = 20 mg/kg bw/day (test result)

Standard respiratory volume, animal (sRVan) = 0.38 m3/kg bw/8 h (default)

Standard respiratory volume, human (sRVhu) = 6.7 m3 / person (default)

Differences in experimental/human exposure conditions (Diff exp. cond) = 1.4 (default)

Oral to inhalation extrapolation between animals and humans (ABSoral,an/ABSinh,hu) = 0.5 (default)

Worker respiratory volume (wRV) = 10 m3 / person (default)

Corrected dose descriptor:

corr inh NOAEC: 24.684 mg/m3

AF for dose response relationship:
1
Justification:
The dose descriptor is an NOAEL.
AF for differences in duration of exposure:
3
Justification:
Default for sub-acute to sub-chronic exposure.
AF for interspecies differences (allometric scaling):
1
Justification:
Default for systemic effects by the inhalation route.
AF for other interspecies differences:
2.5
Justification:
Default for systemic effects for other interspecies differences.
AF for intraspecies differences:
5
Justification:
Default value for workers.
AF for the quality of the whole database:
1
Justification:
Default applied to good quality/standard databases.
AF for remaining uncertainties:
1
Justification:
Default applied to good quality/standard databases.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.658 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):
37.5
DNEL extrapolated from long term DNEL

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:
4.356 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):
150
Dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
653.33 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point correction formula:

Corrected dose descriptor = oral NOAEL x Diff. exp. cond. x (ABSoral,an/ABSderm,hu)     

Given:

Experimental animal: rat    

Relevant human exposure route: dermal

Oral NOAEL from original study (oral NOAEL) = 20 mg/kg bw/day (test result)

Differences in experimental/human exposure conditions (Diff exp. cond) = 1.4 (default)

Oral to dermal extrapolation between animals and humans (ABSoral,an/ABSderm,hu) = 23.33 (based on 70% absortion via the oral route and 3% absorption via the dermal route)

Corrected dose descriptor:              

corr dermal NOAEL:  653.33 mg/kg bw/d

AF for dose response relationship:
1
Justification:
The dose descriptor is an NOAEL.
AF for differences in duration of exposure:
3
Justification:
Default for sub-acute to sub-chronic exposure.
AF for interspecies differences (allometric scaling):
4
Justification:
Default for systemic effects by the dermal route.
AF for other interspecies differences:
2.5
Justification:
Default for systemic effects for other interspecies differences.
AF for intraspecies differences:
5
Justification:
Default value for workers.
AF for the quality of the whole database:
1
Justification:
Default applied to good quality/standard databases.
AF for remaining uncertainties:
1
Justification:
Default applied to good quality/standard databases.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.356 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):
150
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
0.296 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:
NOAEC
Value:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
22.222 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point correction formula:

Corrected dose descriptor = oral NOAEL x 1/sRVan x Diff. exp. cond. x (ABSoral,an/ABSinh,hu)    

Given:

Experimental animal: rat    

Relevant human exposure route: inhalation

Oral NOAEL from original study (oral NOAEL) = 20 mg/kg bw/day (test result)

Standard respiratory volume, animal (sRVan) = 0.45 m3/kg bw/8 h (default)

Standard respiratory volume, human (sRVhu) = 6.7 m3 / person (default)

Differences in experimental/human exposure conditions (Diff exp. cond) = 1 (default)

Oral to inhalation extrapolation between animals and humans (ABSoral,an/ABSinh,hu) = 0.5 (default)

Corrected dose descriptor:             

corr inh NOAEC: 22.222 mg/m3

AF for dose response relationship:
1
Justification:
The dose descriptor is an NOAEL.
AF for differences in duration of exposure:
3
Justification:
Default for sub-acute to sub-chronic exposure.
AF for interspecies differences (allometric scaling):
1
Justification:
Default for systemic effects by the inhalation route.
AF for other interspecies differences:
2.5
Justification:
Default for systemic effects for other interspecies differences.
AF for intraspecies differences:
10
Justification:
Default value for general population.
AF for the quality of the whole database:
1
Justification:
Default applied to good quality/standard databases.
AF for remaining uncertainties:
1
Justification:
Default applied to good quality/standard databases.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.296 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
DNEL extrapolated from long term DNEL

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:
1.556 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:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
466.667 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point correction formula:

Corrected dose descriptor = oral NOAEL x Diff. exp. cond. x (ABSoral,an/ABSderm,hu)     

Given:

Experimental animal: rat    

Relevant human exposure route: dermal

Oral NOAEL from original study (oral NOAEL) = 20 mg/kg bw/day (test result)

Differences in experimental/human exposure conditions (Diff exp. cond) = 1 (default)

Oral to dermal extrapolation between animals and humans (ABSoral,an/ABSderm,hu) = 23.33 (based on 70% absortion via the oral route and 3% absorption via the dermal route)

Corrected dose descriptor:

corr dermal NOAEL: 466.667 mg/kg bw/d

AF for dose response relationship:
1
Justification:
The dose descriptor is an NOAEL.
AF for differences in duration of exposure:
3
Justification:
Default for sub-acute to sub-chronic exposure.
AF for interspecies differences (allometric scaling):
4
Justification:
Default for systemic effects by the dermal route.
AF for other interspecies differences:
2.5
Justification:
Default for systemic effects for other interspecies differences.
AF for intraspecies differences:
10
Justification:
Default value for the general population.
AF for the quality of the whole database:
1
Justification:
Default applied to good quality/standard databases.
AF for remaining uncertainties:
1
Justification:
Default applied to good quality/standard databases.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.556 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
DNEL extrapolated from long term DNEL

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:
0.067 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:
20 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point correction formula:

Corrected dose descriptor = oral NOAEL x Diff. exp. cond. x (ABSoral,an/ABSoral,hu)       

Given:

Experimental animal: rat    

Relevant human exposure route: oral

Oral NOAEL from original study (oral NOAEL) = 20 mg/kg bw/day (test result)

Differences in experimental/human exposure conditions (Diff exp. cond) = 1 (default)

Oral to oral extrapolation between animals and humans (ABSoral,an/ABSoral) = 1 (default)

Corrected dose descriptor:

corr dermal NOAEL: 20 mg/kg bw/d

AF for dose response relationship:
1
Justification:
The dose descriptor is an NOAEL.
AF for differences in duration of exposure:
3
Justification:
Default for sub-acute to sub-chronic exposure.
AF for interspecies differences (allometric scaling):
4
Justification:
Default for systemic effects by the oral route.
AF for other interspecies differences:
2.5
Justification:
Default for systemic effects for other interspecies differences.
AF for intraspecies differences:
10
Justification:
Default value for the general population.
AF for the quality of the whole database:
1
Justification:
Default applied to good quality/standard databases.
AF for remaining uncertainties:
1
Justification:
Default applied to good quality/standard databases.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.067 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
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population