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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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

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

Additional information - workers

  Effect Route DNEL Dose Descriptor Modified Dose Descriptor and Assessment Factors
Acute Exposure Systemic Dermal (a)    
Inhalation (a)    
Local Dermal (b)    
Inhalation (a)    
Long-Term Exposure Systemic  Dermal (a)    
Inhalation (a)    
Local Dermal (b)    
Inhalation (a)    

a) No hazard identified for this route (data available)

b) The data do not allow setting a DNEL.

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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
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:
DNEL (Derived No Effect Level)
Value:
19 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: REACH guidance with modification of some factors
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
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

  Effect Route DNEL Dose Descriptor Modified Dose Descriptor and Assessment Factors
Acute Exposure Systemic Dermal (a)    
Inhalation (a)    
Local Dermal (b)    
Inhalation (a)    
Long-Term Exposure Systemic  Dermal (a)    
Inhalation (a)    
Oral 19 mg/kg/24h 750 mg/kg (NOAEL – 21-week daily oral gavage study based on significant decrease in body weight for females (deemed biologically meaningful) No modification of dose descriptor was needed since study incorporated daily exposures. A total assessment factor of 40 was applied for inter- and intraspecies differences and for overall duration of exposure. 
Local Dermal (b)    
Inhalation (a)    

a) No hazard identified for this route (data available)

b) The data do not allow setting a DNEL.