Registration Dossier
Registration Dossier
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EC number: 232-051-1 | CAS number: 7784-18-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.047 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.068 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Acute DNELs:
Worker: Production of the aluminum fluoride is in excess of 10 t/y. According to the REACh "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, as long term DNELs are available for aluminum fluoride and these substances are not classified for acute toxicity via any route of exposure, separate acute DNELs were not derived.
Long-term DNELs:
DNELs are based on the rat inhalation study (key study selected) entitled "Sub-acute (28-day) inhalation toxicity study with aluminium trifluoride in rats¿. The most sensitive endpoint was selected as repeated dose toxicity. It should be noted that a 5-month inhalational study was available, and would provide a more conservative DNEL value; however this study was not used for DNEL derivation due to deficiencies in the study design. The 5-month inhalational study focused on effects on the lung and brain, and other possible indicators of toxicity (e.g., clinical chemistry, histopathology of other tissues) were not evaluated.
Starting Dose for DNEL calculation:
7 mg/m3(based on NOAEL)
Modified dose for DNEL Calculation
Worker ¿ Inhalation = 7 mg/m3x 6/8 x 6.7/10 = 3.52 mg/m3(no adjustment for absorption)
Worker ¿ Dermal =7 mg/m3x 0.29 m3/kg bw x 1/0.1 = 20.3 mg/kg bw [an adjustment factor of 10% was used to account for Dermal absorption] .
Assessment Factors (AF) ¿
Worker ¿ Inhalation = 2.5 (for non-metabolic species differences) x 5 for (intraspecies difference); no scaling factor required (as per REACh guidance) x 6 (duration factor sub-acute to chronic)
Worker ¿ Dermal = 4 x 2.5 (species differences) x 5 for (intraspecies difference); no scaling factor required (as per REACh guidance) x 6 (duration factor sub-acute to chronic)
Aluminum fluoride is an inorganic compound and is not expected to dissolve in organic solvents. The solubility of aluminum fluoride (AlF3) was measured using flask method and was reported based on Al and F, ranging from 5.3 mg/L to 8.5 mg/L of AlF3 on the basis of F analysis and 5.4 mg/L to 9.4 mg/L of AlF3 on the basis of Al analysis (see Section 4 of this dossier; Behrens and Andersen). Based on a lack of solubility in organic solvents and in water, a 10% absorption factor was assumed. This is consistent with the dermal absorption value assumed by the ECHA Annex 1 Background document to the Opinion proposing harmonized classification and labelling at Community level of the read across substance Trisdoium hexafluroaluminate (ECHA, 2010).
Final DNELs
Worker ¿ Inhalation = 0.047 mg/m3
Worker ¿ Dermal =0.068mg/kg bw
References:
Behrens A & Andersen KJ, Solubility of AlF3. DHI Water & Environment, Agern Allé 11, DK-2970,. (2002)
European Chemicals Agency Committee for Risk Assessment RAC. Annex I Background Document to the Opinion proposing harmonized classification and labelling at Community level of Trisodium hexafluoroaluminate (Cryolite), natural and synthetic. Adopted 23 May 2010.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.008 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.024 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.002 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Acute DNEL:
General population: Production of the aluminum fluoride is in excess of 10 t/y. According to the REACh "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, as long term DNELs are available for aluminum fluoride and these substances are not classified for acute toxicity via any route of exposure, separate acute DNELs were not derived.
Long-term DNELs:
DNELs are based on the rat inhalation study (key study selected) entitled "Sub-acute (28-day) inhalation toxicity study with aluminium trifluoride in rats¿. The most sensitive endpoint was selected as repeated dose toxicity. It should be noted that a 5-month inhalational study was available, and would provide a more conservative DNEL value; however this study was not used for DNEL derivation due to deficiencies in the study design. The 5-month inhalational study focused on effects on the lung and brain, and other possible indicators of toxicity (e.g., clinical chemistry, histopathology of other tissues) were not evaluated.
Starting Dose for DNEL calculation:
7 mg/m3(based on NOAEL)
Modified dose for DNEL Calculation
General Population ¿ Inhalation = 7 mg/m3x 6/24 x 5/7 = 1.25 mg/m3(no adjustment for absorption)
General Population ¿ Oral = 7 mg/m3x 0.29 m3/kg bw x 5/7 = 1.45 mg/kg bw (no adjustment for absorption)
General Population Dermal - 7 mg/m3x 0.29 m3/kg bw x 5/7 x 1/0.1 = 14.5 mg/kg bw (10% absorption factor)
Assessment Factors (AF) ¿
General ¿ Inhalation = 2.5 (for non-metabolic species differences) x 10 for (intraspecies difference); no scaling factor required (as per REACh guidance) x 6 (duration factor sub acute to chronic)
General Population ¿ Oral = 4 x 2.5 (species differences) x 10 for (intraspecies difference); no scaling factor required (as per REACh guidance) x 6 (duration factor sub acute to chronic)
General Population - Dermal = 4 x 2.5 (species differences) x 10 for (intraspecies difference); no scaling factor required (as per REACh guidance) x 6 (duration factor sub acute to chronic)
Absorption
Aluminum fluoride is an inorganic compound and is not expected to dissolve in organic solvents. The solubility of aluminum fluoride (AlF3) was measured using flask method and was reported based on Al and F, ranging from 5.3 mg/L to 8.5 mg/L of AlF3 on the basis of F analysis and 5.4 mg/L to 9.4 mg/L of AlF3 on the basis of Al analysis (see section 4, Behrens and Andersen). Based on a lack of solubility, a 10% absorption factor was assumed This is consistent with the dermal absorption value assumed by the ECHA Annex 1 Background document to the Opinion proposing harmonized classification and labelling at Community level of the read across substance Trisdoium hexafluroaluminate (ECHA, 2010).
Final DNELs
General Population ¿ Inhalation = 0.0083 mg/m3
General Population ¿ Oral = 0.0024 mg/kg bw
General Population - Dermal =0.024mg/kg bw
References:
Behrens A & Andersen KJ, Solubility of AlF3. DHI Water & Environment, Agern Allé 11, DK-2970,. (2002)
European Chemicals Agency Committee for Risk Assessment RAC. Annex I Background Document to the Opinion proposing harmonized classification and labelling at Community level of Trisodium hexafluoroaluminate (Cryolite), natural and synthetic. Adopted 23 May 2010.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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