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EC number: 231-146-5 | CAS number: 7440-36-0
LD50 (oral ): >20000mg/kg bw/day
LD50 (dermal): >8300mg/kg bw
LC50 (inhalation): >5200mg/m³
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. Furthermore, in vitro bioaccessibility testing in various artificial body fluids has shown that antimony metal compared to diantimony trioxide has a similar release rate of antimony ions (please refer to the respective entry under the endpoint toxicokinetics).
In view of this, and since transformation / dissolution testing (CanMet, 2010) has shown that antimony metal may be expected to release trivalent antimony ions upon dissolution, it may be assumed that human exposure towards antimony metal is secondary to that of antimony trioxide. Thus, read-across for reproductive toxicity is considered justified.
Justification for selection of acute toxicity – oral endpoint
Weight of evidence information
Justification for selection of acute toxicity – inhalation endpoint
Justification for selection of acute toxicity – dermal endpoint
Acute oral toxicity
The animal studies on acute oral exposure are all old, they do not comply with today standards and in most of them mortality was the only parameter investigated as they were designed to determine at what dose level death occurred. Still, they indicate that oral LD50 is in excess of 20,000 mg/kg bw in rats which will be used for classification purposes.
LD50 oral, rat > 20,000 mg/kg bw
The classification criteria according to regulation (EC) 1272/2008 as acutely toxic are not met since the ATE is above 2,000 mg/kg body-weight, hence no classification required.
Specific target organ toxicant (STOT) – single exposure: oral
The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, oral for a Category 1 classification of 300 mg/kg bw and at the guidance value, oral for a Category 2 classification of 2000 mg/kg bw. No classification required.
Acute inhalation toxicity
The reference Leuschner (2006) is considered as the key study for acute inhalation toxicity and will be used for classification. Rats were nose only exposed towards diantimony trioxide dust for 4 hours at 5.2 mg/L air. During the conduct of the study no mortalities occurred.
LC50 inhalation, rat > 5.2 mg/L air
The classification criteria according to regulation (EC) 1272/2008 as acutely toxic are not met since the ATE for dusts and mists is above 5.0 mg/L, hence no classification required.
Specific target organ toxicant (STOT) – single exposure: inhalation
The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, inhalation dust/mist/fume are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance values, inhalation dust/mist/fume for a Category 1 classification of 1.0 mg/L/4 h and at the guidance value or inhalation dust/mist/fume for a Category 2 classification of 5.0 mg/L/4 h. Therefore, no classification is required. However, such classification is also not warranted, since observations on respiratory irritation in test animals were not observed at the highest inhalation exposure level. No relevant pulmonary changes were observed in the 5 localisations of the lung neither in the rats sacrificed 24 hours after exposure nor the rats sacrificed 14 days after exposure.
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