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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.76 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
528.947 mg/m³
Explanation for the modification of the dose descriptor starting point:

Data are only available by oral exposure.  The substance is not typically of respirable particle size

AF for dose response relationship:
1
Justification:
Issues of reliability
AF for differences in duration of exposure:
6
Justification:
duration of exposure: subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for intraspecies differences:
5
Justification:
intraspecies – workers
AF for the quality of the whole database:
1
Justification:
quality of the database
AF for remaining uncertainties:
2.5
Justification:
remaining differences
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:
1 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
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Data are only available by oral exposure.  

AF for dose response relationship:
1
Justification:
Issues of reliability
AF for differences in duration of exposure:
6
Justification:
duration of exposure: subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for intraspecies differences:
5
Justification:
intraspecies – workers
AF for the quality of the whole database:
1
Justification:
quality of the database
AF for remaining uncertainties:
2.5
Justification:
remaining differences
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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The data available for the substance suggest that the substance is not systemically toxic. Repeat dose DNELs are assigned for workers for the same of completeness. The hazard determined by the data are available are local effects to skin and eye by irritation. The available data do not determine a dose response relationship meaning that a DNEL cannot be assigned. It is, therefore, necessary to apply a qualitative approach to risk management e.g. use gloves and goggles to avoid exposure to skin and eyes.

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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

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:
medium hazard (no threshold derived)

Additional information - General Population

The data available for the substance suggest that the substance is not systemically toxic. The substance is intended for use in industry only and will not be directly exposed to consumers. Repeat dose DNELs are therefore not assisgned since no hazard is identified. The hazard determined by the data are available are local effects to skin and eye by irritation. The available data do not determine a dose response relationship meaning that a DNEL cannot be assigned. It would, therefore, be necessary to apply a qualitative approach to risk management e.g. use gloves and goggles to avoid exposure to skin and eyes. Such controls would not generally be considered appropriate for control of exposure to consumers. In practive, however, exposure to consumers is prevented by a lack of exposure, since the substance is used only within industry.