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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.4 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):
225
Modified dose descriptor starting point:
NOAEC
Value:
1 670 mg/m³
Explanation for the modification of the dose descriptor starting point:
the absorption of the substance via the oral route is 100% and via the inhalation route 10% (see toxicokinetic assessment). For route-to-route extrapolation the following factors were applied to come to a human NOAEC: interspecies 4, bw 70 kg, 10 m3 inhalation volume/working day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
default assessment factor
AF for interspecies differences (allometric scaling):
1
Justification:
see route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
default value for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
default assessment factor for extraopolation to workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
3
Justification:
risk assessment is based on data on analogue substance with different phys-chem properties
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:
0.11 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):
900
Modified dose descriptor starting point:
NOAEL
Value:
95 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
based on the corrosiveness of the substance oral and dermal absorption are set at 100%
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
default for extrapolation from sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default for differences in metabolic rate between rat and human
AF for other interspecies differences:
2.5
Justification:
default value for interspecies differences
AF for intraspecies differences:
5
Justification:
default for worker extrapolation
AF for the quality of the whole database:
1
Justification:
in general good quality data are available
AF for remaining uncertainties:
3
Justification:
risk assessment is based on data on analogue substance with different phys-chem properties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Based on the classification of the substance as corrosive, risk management measures need to be in place. The risk assessment shows that when applying the measures, the risk for systemic effects is adequately controlled, thus avoiding any secondary effects of the substance.

General Population - Hazard via inhalation 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
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:
no hazard identified
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

No consumer exposure is expected