Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-601-8 | CAS number: 7647-18-9
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 0.042 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.042 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 3
- Dose descriptor:
- LOAEC
- Value:
- 3 mg/m³
- AF for interspecies differences (allometric scaling):
- 3
- Justification:
- As per the ECHA Guidance R8, application of assessment factors needs be considered. In interspecies extrapolations for systemic effects, assessment factors of up to 10 can be appropriate to account for differences such as allometric factors that yield differences in metabolic rates or toxicokinetics. For local effects associated with inhalation exposure, an assessment factor of 2.5 is suggested.
In as much as antimony is not metabolized, interspecies variability from this source would not be expected. Moreover, the HEC calculations performed account for expected toxicokinetic differences related to pulmonary deposition and clearance, further reducing uncertainty in extrapolation between species.
Since the HEC calculations address and correct for differences to be addressed by assessment factors, the application of both a HEC and AFs would be redundant in an interspecies comparison. Indeed, the HEC correction lowers the expected human NOAEC by a factor of 16, much more than the recommended default assessment factor of 2.5. A minimal Assessment Factor of 1.0 is thus appropriate for HEC corrected local effects in the lung. The NOAEC (based upon antimony content) remains at 0.051 mg/m3 after consideration of interspecies differences. - AF for intraspecies differences:
- 1
- Justification:
- An additional assessment factor is suggested to account for variability in response between workers. Assessment factors recommended range from 5 in the ECHA R8 to 3 as suggested by ECETOC (2003).
An assessment factor of 3 appears to be applicable to antimony (III) compounds since the pulmonary impacts of concern are local and do not entail metabolism of deposited aerosols (ECETOC, 2010). Hattis and Silver (1994) and Hattis et al. (1999) similarly concluded, in an analysis of variability in toxicodynamic responses for local irritants (including pulmonary toxicants), that an assessment factor of 3 was more appropriate. Justification for lower assessment factors is also derived from greater homogeneity of worker populations when occupational hygiene regimens and other risk management practices (Hoet, 2009; i2a, 2017) are in place to reduce sources of variability in responses to exposure. For example, routine monitoring of urinary antimony excretion and pulmonary function (by both spirometry and annual radiographic evaluations of the lungs) essentially precludes the development of pneumonitis in workers. Application of an assessment factor of 3 yields a DNEL estimate of 0.017 mg/m3 based upon antimony content. - AF for remaining uncertainties:
- 1
- Justification:
- The need for application of further assessment factors was considered and were not deemed as necessary. For example, the DNEL derivation is based upon chronic inhalation data and correction for exposure duration is not warranted. Moreover, three other chronic rat inhalation studies have been conducted and there is reasonable consistency in the inflammatory responses that have been produced (Newton et al., 1994; Groth et al., 1986; Watt, 1983). Confidence in the dose-response for antimony induced inflammation is thus relatively high and additional assessment factors for data quality are not needed.
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:
- DNEL (Derived No Effect Level)
- Value:
- 138 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: The DNEL derivation for antimony metal is based on state-of-the-art approaches and using substance-specific information.
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 686 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Selection of the relevant dose-descriptor
No studies evaluating the systemic toxicity resulting from dermal exposure to antimony pentachloride were found. Estimation of a long term systemic DNEL for the dermal exposure route was thus undertaken via oral to dermal route extrapolation. Further given that studies of oral toxicity have not been conducted for antimony pentachloride, studies with diantimony trioxide were selected on read across. Trivalent antimony compounds are generally more toxic than their pentavalent counterparts, making selection of diantimony trioxide for route to route extrapolation a conservative mode of DNEL calculation. Moreover, conversion of antimony from the pentavalent state to the trivalent state occurs in vivo. The NOAEL of 1686 mg/kg bw/d from a subchronic oral toxicity study of diantimony trioxide in rats (Hext et al., 1999) was selected as being the most relevant for estimating systemic effects that might be associated with dermal uptake of antimony pentachloride.
Modification of the dose descriptor to the correct starting point
Because the route of exposure in animal toxicity studies (oral) is not the same for which extrapolations to humans are to be made (dermal), an evaluation must be undertaken to determine if there is a need to adjust the animal NOAEL starting point. In principle, this entails evaluation of whether different rates of uptake are to be expected via the two different exposure routes. In the specific case of the antimony compounds under consideration, uptake rates after oral or dermal exposure are quite limited and can, for the purpose of DNEL derivation, be presumed to be the same: the absorption of antimony compounds such from the gastrointestinal tract after oral exposure is, based upon studies in rodents, very low and on the order of 0.05 to 0.3%. In vivo dermal uptake studies are lacking, but in vitro percutaneous absorption studies suggest that dermal uptake does not exceed 0.1%. Dermal uptake rates are thus comparable to, or less than, oral uptake rates. Since the effects of diantimony trioxide are mediated by release and subsequent dermal uptake of the Sb oxyanions, read across to other antimony compounds is possible. The NOAEL can thus be adjusted for the antimony content of diantimony trioxide [(243.6/291.5) x 1686 = 1409] yielding a NOAEL indexed to antimony content of 1409 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- Adequate data available
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Correction for differences in metabolic rate (AS)
- AF for other interspecies differences:
- 2.5
- Justification:
- Remaining differences (e.g. toxicokinetics/dynamics
- AF for intraspecies differences:
- 5
- Justification:
- Workers
- AF for the quality of the whole database:
- 1
- Justification:
- No need for a further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- Route extrapolatio: oral to dermal
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
General Population - Hazard via inhalation 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
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
- Long-term DNEL for workers – inhalation, local effects
- Long-term DNEL for workers – dermal, systemic effects
Two DNELs have been derived for antimony pentachloride:
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.