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Diss Factsheets
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EC number: 215-713-4 | CAS number: 1345-04-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Endpoint summary
Administrative data
Description of key information
Oral:
Two repeated dose oral studies (Sunagawa, 1981; Hext et al., 1999) suggest that diantimony trioxide may be toxic to the liver. This being based on a 10 % increase in liver weight. In addition, one study (Hext et al., 1999) exhibited significantly elevated ASAT values and significantly decreased ALP values. The other study (Sunagawa, 1981) revealed both ASAT and ALP levels to be significantly elevated. However, in the absence of histological change or any clinical signs of antimony intoxication to support liver adversity, the differences are regarded as adaptive or incidental to treatment with diantimony trioxide. A NOAEL of 1686 mg/kg/d for liver toxicity is suggested.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 686 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- One key study available (90-day repeated dose toxicity study in rats according to OECD 407, under GLP) which is reliable with minor restrictions (RL=2). The overall quality of the database is therefore high.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The is no indication for systemic toxicity in several repeated dose toxicity studies via oral and inhalation route, thus a NOAEC for inhalation, systemic toxicity is not identified.
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Repeated dose toxicity, oral:
The reference Hext P. M., Pinot P. J. and Rimmel B. A. (1999) is considered as the key study for repeated dose toxicity via oral application and will be used for classification. Rats were dosed at 20,000 ppm/day orally via feed for 90 days. Based on the lack of any adverse effects, the no observed adverse effect level (NOAEL) via oral application for diantimony trioxide was established at 1686 mg/kg bw/day.
The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – repeated exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure, and the no observed adverse effect level (NOAEL) via oral application is above the guidance value for a Category 1 classification of 10 mg/kg bw/day and above the guidance value for a Category 2 classification of 100 mg/kg bw/day.
For the reasons presented above, no classification for specific target organ toxicant (STOT) – repeated exposure, oral is required.
Repeated dose toxicity, dermal: No classification for specific target organ toxicant (STOT) – repeated exposure, dermal is required.
Repeated dose toxicity, inhalation: No classification for specific target organ toxicity (STOT) - repeated exposure, inhalation is required
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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