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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.939 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
225
Dose descriptor starting point:
LOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
220.4 mg/m³
AF for dose response relationship:
3
Justification:
based on LOAEL
AF for differences in duration of exposure:
6
Justification:
based on 28-d RDT study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route - already included in route-to-route
AF for other interspecies differences:
1
Justification:
Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.
AF for intraspecies differences:
5
Justification:
AF for workers
AF for the quality of the whole database:
1
Justification:
Reliability 1
AF for remaining uncertainties:
2.5
Justification:
REACH guidance
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:
no hazard identified
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:
0.725 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):
450
Dose descriptor starting point:
LOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
108.7 mg/m³
AF for dose response relationship:
3
Justification:
LOAEL
AF for differences in duration of exposure:
6
Justification:
based on 28-d RDT study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route - already included in route-to-route extrapolation.
AF for other interspecies differences:
1
Justification:
Due to the properties of the substance, a serious dangerous effect is not expected and the AFs used are sufficient.
AF for intraspecies differences:
10
Justification:
AF for general population.
AF for the quality of the whole database:
1
Justification:
Reliability 1
AF for remaining uncertainties:
2.5
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:
no hazard identified
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:
0.139 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):
1 800
Dose descriptor starting point:
LOAEL
Value:
250 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
subacute study
AF for interspecies differences (allometric scaling):
4
Justification:
rat
AF for intraspecies differences:
10
Justification:
gen. population
AF for the quality of the whole database:
3
Justification:
LOAEL
AF for remaining uncertainties:
2.5
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