Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Modified dose descriptor starting point:
LOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Dose descriptor:
NOAEC
Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

nhalation acute toxicity test results in LOAEC value of 0.45mg /l. This value correspond to 450mg/m3. To use a LOAEC as starting point to derive a DNEL is necessary to carry out a correction. Initially, an assessment factor of 3 is applied to determine the NOAEC. Thus, NOAEC is NOAEC=(450 mg/m3)/3=150 mg/m3 Duration of the exposure shall be corrected since the test was performed for 4 hours. In addition, breathing volume for rats and humans shall also be considered: NAEC=150×4h/8h×6.7m3/10m3=50.25 mg/m3 Assessment factors for intraspecies and interspecies variation are applied. The variation in the sensitivity of rats and humans is corrected by applying an assessment factor of 4. An assessment factor of 5 is used for workers. DNEL is calculated as NAEC/(Overall AF). Thus, DNEL=(50.25 mg/m3)/(4×5)=2.5 mg/m3 The SCOEL have recommended (1998) an IOEL value of 2.5 mg/m3 F in a mixture of HF and inorganic fluorides (8-hour TWA).  They concluded that the 8-hour TWA was sufficient to protect against systemic effects (fluorosis) . The use of IOEL valuees is justified as there is no new scientific information which indicates that the IOEL values do not provide an appropriate level of protection under REACH.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population