Registration Dossier
Registration Dossier
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EC number: 233-433-0 | CAS number: 10163-15-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- other toxicological threshold
- Value:
- 2.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
An OECD 422 study has identified the primary toxicological effects of disodium fluorophosphate as being related to the fluoride content (fluorosis). Despite the failure of the study to identify a NOAEL, it is suggested that sufficient information for a qualitative understanding of the toxicological properties of the substance is available.
As the effects of inorganic fluorides have been extensively studied, it is therefore not considered to be ethically sound to investigate the effects of disodium fluorophosphate further. To this end it is recommended that the exposure limit for inorganic fluorides (NIOSH, UK HSE) is observed and is used in the risk assessment in place of a DNEL. The OEL is 2.5 mg F/m3. This value is considered to be low enough to be protective of any potential effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: The DNEL is based on the long-term (8-hr TWA) OEL of 2.5 mg/m3 with an assessment factor of 2 applied to account for the differences in workers and the general population.
- Overall assessment factor (AF):
- 2
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 2
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:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
An OECD 422 study has identified the primary toxicological effects of disodium fluorophosphate as being related to the fluoride content (fluorosis). Despite the failure of the study to identify a NOAEL, it is suggested that sufficient information for a qualitative understanding of the toxicological properties of the substance is available.
As the effects of inorganic fluorides have been extensively studied, it is therefore not considered to be ethically sound to investigate the effects of disodium fluorophosphate further. To this end it is recommended that the exposure limit for inorganic fluorides (NIOSH, UK HSE) is observed and is used in the risk assessment in place of a DNEL. The OEL is 2.5 mg F/m3. To derive an appropriate value for use in the risk assessment of consumers an assessment factor of 2 has been applied to the OEL to account for the differences in workers and the general population, specifically; 24 hrs versus 8 hrs, bodyweight; 60 kg versus 70 kg and inhalation rate; 0.83 m3/hr versus 1.25 m3/hr.
This value is considered to be low enough to be protective of any potential effects.
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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