Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.86 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:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
139.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

Oral absorption rate: both oral and inhalation absorptions set at 50 % (oral absorption not expected to be lower than the inhalation absorption)

NOAEL oral * (1/SRV) * sRV*ABS = 79*(1/0.38)*(0.67)*(1) = 139.3 mg/m3

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
default value systemic effect for conversion of oral dose to inhalation concentration, using the section R.8.4.2 of the REACh guidance document
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
5
Justification:
default value for worker
AF for the quality of the whole database:
1
Justification:
reliability 1 or 2 data
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
0.26 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:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
79 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

Default value of oral-to- dermal extrapolation = 1 (oral and dermal absorption both set at 50%)

NOAEL oral *ABS = 79*1 = 79 mg/kg bw/d

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
factor for allometric scaling (4 for rat)
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
5
Justification:
default value for worker
AF for the quality of the whole database:
1
Justification:
reliability 1 or 2 data
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
0.46 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:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
68.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

Oral absorption rate: both oral and inhalation absorptions set at 50 % (oral absorption not expected to be lower than the inhalation absorption)

NOAEL oral * (1/SRV) * ABS = 79*(1/1.15)* (1) = 68.7 mg/m3

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
default value for conversion of oral dose to inhalation concentration, using the section R.8.4.2 of the REACh guidance document
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
10
Justification:
default value general population
AF for the quality of the whole database:
1
Justification:
reliability 1 or 2 data
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
0.13 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:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
79 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

Default value of oral-to- dermal extrapolation = 1 (oral and dermal absorption both set at 50%)

NOAEL oral *ABS = 79*1 = 79 mg/kg bw/d

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
factor for allometric scaling (4 for rat)
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
10
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
reliability 1 and 2 data
AF for remaining uncertainties:
1
Justification:
not concerned
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
0.13 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:
79 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
79 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor calculation:

No route to route extrapolation applicable (oral route data)

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
6
Justification:
for extrapolation subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
factor for allometric scaling (4 for rat)
AF for other interspecies differences:
2.5
Justification:
default value systemic effect
AF for intraspecies differences:
10
Justification:
default value for general population
AF for the quality of the whole database:
1
Justification:
reliability 1 and 2 data
AF for remaining uncertainties:
1
Justification:
not concerned
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