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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.03 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
50.8 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC is used as starting point
AF for differences in duration of exposure:
2
Justification:
default AF for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
5
Justification:
default AF for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
0.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
NOAEC is used as starting point
AF for differences in duration of exposure:
2
Justification:
default AF for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
5
Justification:
default AF for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
0.056 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Modified dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default AF for use of NOAEL as starting point
AF for differences in duration of exposure:
6
Justification:
default AF for subacute to chronic
AF for interspecies differences (allometric scaling):
2.4
Justification:
allometric scaling factor for rabbit
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
5
Justification:
default AF for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
0.001 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
other: NOAEL
AF for dose response relationship:
5
Justification:
LOAEL as starting point. Edema, atonia and desquamation were observed at lowest dose.
AF for differences in duration of exposure:
2
Justification:
Most effects visible in 3rd week of treatment where already visibile in the 2nd week
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling applied
AF for other interspecies differences:
1
AF for intraspecies differences:
5
Justification:
default AF for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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

The DNELs were derived in accordance with the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.051 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Value:
10.1 mg/m³
AF for dose response relationship:
1
Justification:
NOAEC used as starting point
AF for differences in duration of exposure:
2
Justification:
default factor sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
Justification:
default factor for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for the general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
0.51 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
NOAEC is used as starting point
AF for differences in duration of exposure:
2
Justification:
default AF for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for the general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
0.028 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
360
Modified dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default AF for NOAEL
AF for differences in duration of exposure:
6
Justification:
default AF for subacute to chronic
AF for interspecies differences (allometric scaling):
2.4
Justification:
allometric scaling factor for rabbit
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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:
0.001 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor:
other: LOAEL
AF for dose response relationship:
5
Justification:
LOAEL as starting point. Edema, atonia and desquamation were observed at lowest dose.
AF for differences in duration of exposure:
2
Justification:
Most effects visible in 3rd week of treatment where already visibile in the 2nd week
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
1
AF for intraspecies differences:
10
Justification:
default AF for general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
262.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

according to ECHA Guidance Chapter R.8

AF for dose response relationship:
1
Justification:
default AF when NOAEL is used as starting point DNEL calculation
AF for differences in duration of exposure:
2
Justification:
default AF for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for other interspecies differences:
2.5
Justification:
default AF for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for general population
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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

The DNELs were derived in accordance with the Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8.