Registration Dossier
Registration Dossier
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EC number: 927-629-1 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 3
- Dose descriptor:
- NOAEC
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:
- 234.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Antimony as a semi-metal is subject at its surface to a passivation by the formation of a layer of antimony trioxide. In particular for antimony metal powder because of its large surface area, the oxide layer will form a quantitatively relevant portion of the entire particle. In view of this, and since transformation / dissolution testing has shown that antimony metal may be expected to release trivalent Sb cations upon dissolution, it may be assumed that human exposure towards antimony metal is secondary to that of antimony trioxide. Thus, levels of protection designed for diantimony trioxide will also be adequate for antimony metal, by applying the same DNELs (inhalation, local). Since only local effects in the respiratory tract were seen in animal studies and no systemic effects could be observed, long-term DNELs were derived for local effects only. The same applies for the carcinogenic potential of diantimony trioxide. Because it can be assumed that particle deposition followed by macrophage infiltration, pulmonary inflammation and impaired clearance are pivotal initial steps in the carcinogenic process, diantimony trioxide can be regarded as a threshold carcinogen and thus no DMEL was derived. |
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
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:
- 140.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- 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:
- 140.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Long-term exposure - systemic effects oral DNEL, children = 14.08 mg/kg bw/day (AF=100) Long-term exposure - systemic effects dermal DNEL, children = 14.08 mg/kg bw/day (AF=100) Long-term exposure - local effects inhalation DNEL, consumer = 0.1 mg/m³ (AF=5) Antimony as a semi-metal is subject at its surface to a passivation by the formation of a layer of antimony trioxide. In particular for antimony metal powder because of its large surface area, the oxide layer will form a quantitatively relevant portion of the entire particle. In view of this, and since transformation / dissolution testing has shown that antimony metal may be expected to release trivalent Sb cations upon dissolution, it may be assumed that human exposure towards antimony metal is secondary to that of antimony trioxide. Thus, levels of protection designed for diantimony trioxide will also be adequate for antimony metal, by applying the same DNELs (inhalation, local). Since only local effects in the respiratory tract were seen in animal studies and no systemic effects could be observed, long-term DNELs were derived for local effects only. The same applies for the carcinogenic potential of diantimony trioxide. Because it can be assumed that particle deposition followed by macrophage infiltration, pulmonary inflammation and impaired clearance are pivotal initial steps in the carcinogenic process, diantimony trioxide can be regarded as a threshold carcinogen and thus no DMEL was derived. |
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