Registration Dossier
Registration Dossier
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EC number: 241-022-2 | CAS number: 16949-65-8
Toxicological Summary
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
Inhalation 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
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