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EC number: 909-586-0 | CAS number: -
- 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
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.63 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
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
This discussion relates to the main component, aluminium oxide, and the assuesment of the reaction mass based upon its main component can be considered as a worst case approach. Generic issues relating to inorganic substances can be considered as appropriate for all other components within the reaction mass.
Aluminium oxide
Key study for dose descriptor
Gross et al. (1973) is considered the most adequate study from which to obtain a dose descriptor for a DNEL for repeated dose toxicity (inhalation, local effect) for aluminium oxide. The NOAEC from Gross et al. (1973), a chronic study, is 70 mg/m³. No alveolar proteinosis or endogenous lipid pneumonitis was observed. Alveoli were filled with dust-filled but otherwise “well-preserved” macrophages, septal walls were not thickened, there was no evidence of stromal proliferation, and no fibrosis was found in the lungs or lymph nodes.
Key study: Gross et al. (1973)
Dose descriptor: 70 mg/m³, NOAEC
Test animal: Rat
Test substance: Aluminium oxide, mean diameter 0.8 µm
Doses used: 0, 30, 70 mg/m³
Duration of exposure in the experiment: 6 (for 70 mg/m³) and 12 months (for 30 mg/m³); 6 hours per day, 5 days per week; follow-up to 30 months.
Effects observed: Dust-filled macrophages; no alveolar proteinosis, endogenous lipid pneumonitis or fibrosis.
Mode of action:
Based on the weight of evidence, the target substances behave as low cytotoxic, poorly soluble particulates (PSPs). From a risk assessment perspective based on studies in rats, two possible thresholds can be envisioned for pulmonary toxic effects on chronic exposure to ‘nuisance” PSPs:
1) a dosimetric threshold to avoid overloading macrophages and leading to a persistent inflammatory response;
2) a mechanistic threshold greater than the dosimetric threshold that occurs when anti-inflammatory responses are overwhelmed and effects may progress to fibrosis (Oberdorster, 2002).
For a persistent inflammatory response potentially leading to fibrosis, the mode of action for aluminium oxide (dust), aluminium hydroxide and aluminium powder (uncoated) in the respirable and inhalable size range is threshold and related to volumetric overloading of macrophages.
Calculation of DNEL according the ECHA guidance (ECHA guidance, Chapter R8, p27):
Modification of starting point to correct for differences in inhalation volume between the rats and lightly active humans –
NOAEC(corrected) = NOAEC * 6.7m³ (8h)/10m³ (8h)
= 70 * 6.7/10
= 46.9 mg/m³; corrected starting point
Assessment factors:
Interspecies: 1
Allometric scaling is not necessary as the mode of action is a portal-of-entry effect (overload) and adjustment for inhalatory volume has been carried out to modify the starting point; scientific evidence suggests rats are at greater susceptibility to overload than humans (Oberdorster, 1995; Pauluhn, 2010), therefore a factor of 2.5 for remaining effects was not considered appropriate.
Intraspecies: 3
Eurometaux has adopted the ECETOC (2010) approach for intraspecies and interspecies assessment factors. Therefore, the client indicated that this value should be inserted here
Duration of exposure: 1
The duration of exposure was adequate.
Dose response extrapolation: 1 (Based on a NOAEC)
Adequacy of database: 1
This study assessed only histopathological effects and did not look at sensitive effects such as inflammatory markers in the BALF. However, the evidence for the lack of fibrogenic effects of Al2O3dust is also supported by consistent results from intratracheal instillation studies and the inhalation studies of Christie et al. (1963) and Pigott et al. (1981). An AF of 1 is considered appropriate.
Total assessment factor = 3
Calculated DNELlong-term,workerfor aluminium oxide = 46.9/3 = 15.63 mg/m³, respirable, 8 hour TWA for Al2O3
As the weight of evidence supports the low cytotoxic and low fibrogenic nature of aluminium oxide and the calculated DNEL is higher than the general dust limits used in setting Occupational Exposure Limits,the general dust limits are considered appropriate for exposure scenarios for aluminium oxide dust.
Proposed DNELlong-term,workerfor aluminium oxide = 3 mg/m³, respirable, 8 hour TWA
Summary DNEL derivation:
Gross (1973) | ||
Effect: | Pulmonary Toxicity (Repeated Dose) | |
Target Substance: | Aluminium oxide (CAS# 1344-28-1) | |
Target Population: | Workers (exposed to dust) | |
Exposure Route: | Inhalation | |
Exposure Duration: | Repeated Dose (6 or 12 months) | |
Effect type: | Local/Chronic | |
KEY REFERENCE: | Gross P, Harley R, de Treville RTP. 1973. Pulmonary reaction to metallic aluminium powders. Arch Environ Health.26:227-236. | |
TEST ANIMAL: | Rats | |
TEST SUBSTANCE: | Al2O3 | |
EXPOSURE ROUTE/MEDIUM/ CONCENTRATION/DURATION | Inhalation/ dust, powder/ 0, 30, 70 mg/m3/6 hours per day, 5 days a week for either 6(70 mg/m3)or 12(30 mg/m3)months. | |
EFFECTS: | Dust-filled macrophages; no alveolar proteinosis, endogenous lipid pneumonitis or fibrosis. | |
MODE OF ACTION: | Threshold (portal of entry - overload) | |
RELEVANT DOSE-DESCRIPTOR: | 70 | mg/m3(NOAEC) |
MODIFYING FACTORS: | ||
Adjustment for differences in exposure conditions and respiratory rates | ||
Inhalation volume (experiment) | 6.7 | Inhalation volume (rat resting): 6.7 m3(8h). |
Inhalation volume (target population) | 10 | Inhalation volume (human light activity): 10 m3(8h) |
Ratio of bioavailabilities between test and target species: | 1 | No evidence suggesting that there would be a difference between animal species with respect to actual bioavailability. |
Ratio of inhalation bioavailabilities between test and target substances: | 1 | |
TOTAL MODIFICATION FACTOR: | 0.67 | |
Corrected Starting Point: | 46.90 | mg/m3(70*6.7/10) |
ASSESSMENT FACTORS | ||
Interspecies: | 1 | Allometric scaling not necessary as adjustment for inhalation volume has already been done; mode of action is a portal-of-entry effect (overload); scientific evidence suggests a greater susceptibility to overload in rats (Pauluhn, 2010; Jarabek et al., 2005) therefore a factor of 2.5 for remaining uncertainty (the default in the ECHA Guidance) was not considered appropriate. |
Intraspecies: | 3 | ECETOC (2010) gives a value of 3 for the worker population. A value of 5 would be inserted for the general population. Note: Eurometaux has adopted the ECETOC (2010) approach for intraspecies and interspecies assessment factors. Therefore, the client indicated that these values should be inserted here. |
Duration of exposure: | 1 | The duration of exposure was adequate. |
Dose-response extrapolation: | 1 | Based on a NOAEC |
Adequacy of database: | 1 | Based on histopathological effects - a strong but not very sensitive endpoint. However, the evidence for the lack of fibrogenic effects of Al2O3dust in the occupational setting is supported by consistent results from intratracheal instillation studies. Confidence in the database is considered strong. |
TOTAL ASSESSMENT FACTOR: | 3 | |
DNEL-long-term (worker) | 15.63 | mg/m3Al2O3, daily 8 hour TWA (respirable)* |
* not applicable to aluminium fume. |
Short-term DNEL
According to REACH guidance (ECHA, 2008, Chapter 8, p.106), there is no generally accepted methodology for the establishment of an acute toxicity DNEL for effects occurring after a single exposure of a few minutes up to 24 hours. In most cases it may be unnecessary to derive an acute DNEL, as the long-term DNEL is usually sufficient to ensure that these effects do not occur. In summary, according to ECHA, a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures, for example, connecting or disconnecting vessels.
The weight of evidence suggests that these substances behave as poorly soluble low cytotoxicity particulates. A chemical-specific acute toxicity hazard leading to C&L was not identified for the target substances. The long-term DNEL should ensure that these effects do not occur.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
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:
- 3.29 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Summary DNEL derivation:
Oral DNEL Derivation Summary | ||
TEH-113 | ||
Effect: | Repeated Dose - neurotoxicity | |
Target Substance: | Al2O3 | |
Target Population: | Adults | |
Exposure Route: | Oral exposure | |
Effect type: | Long-term, systemic | |
KEY REFERENCE: | Developmental and One-Year Chronic Neurotoxicity Study of Aluminium Citrate in Rats. ToxTest, Alberta Research Council Inc. Project No. TEH-113. | |
TEST ANIMAL: | Sprague-Dawley male and female rats | |
TEST SUBSTANCE: | Aluminium citrate (CAS# 31142-56-0) | |
EXPOSURE ROUTE/MEDIUM/ CONCENTRATION/DURATION | Pregnant females were exposed to Al-citrate at dose levels 30, 100 and 300 mg Al/kg bw/day from GD6 to GD21 and from PND 1 to PND 21. Pups were exposed to Al-citratein uteroand with maternal milk from PND 1 to PND 21, 64, 120 or 364. | |
EFFECTS: | A deficit in fore- and hind-limb grip strength in the mid-dose group, supported by evidence of dose response for this endpoint | |
ENDPOINT- CONCENTRATION: | LOAEL - 100 mg Al/kg bw/day; NOAEL - 30 mg Al/kg bw/day | |
MODE OF ACTION: | Threshold | |
RELEVANT DOSE-DESCRIPTOR: | 30 | mg Al/kg bw/day; NOAEL |
MODIFYING FACTORS | ||
Route-to-route: | 1 | Oral to oral extrapolation with the same units (ECHA, 2008) |
Bioavailability differences between animal species: | 1 | Evidence suggests no difference between animal species for oral exposure (Priest, 2010). |
Ratio of bioavailability between test and target substance: | 4.39 | Priest (2010): ratios of the whole body fractional uptake for Al-citrate (0.079%) to the whole body fractional uptakes of Al metal (<0.015%), Al-oxide (0.018%), and Al-hydroxide (0.025%). Note: The whole body fractional uptake (f) of Al metal powder was g |
TOTAL MODIFICATION FACTOR: | 4.39 | |
Corrected Starting Point: | 131.67 | mg Al/kg bw/day |
ASSESSMENT FACTORS | ||
Interspecies: | 4 | 4 for allometric scaling (rats to humans)[ECHA default, 2008]. Note: Eurometaux has adopted the ECETOC (2010) approach for intraspecies and interspecies assessment factors. Therefore, the client indicated that an additional factor of 2.5 was not necessary |
Intraspecies: | 5 | ECETOC (2010) gives a value of 5 for the general population. A value of 3 would be inserted for the worker population. Note: Eurometaux has adopted the ECETOC (2010) approach for intraspecies and interspecies assessment factors. Therefore, the client ind |
Duration of exposure: | 1 | The study exposed the animals until they were 1 year of age. |
Dose-response extrapolation: | 1 | Based on NOAEL (ECHA, 2008) |
Adequacy of database: | 2 | Evidence for differences in toxicokinetics of Al when complexed with citrate (Jouhanneau et al., 1997); uncertainty as to the critical period of exposure and lack of information on food consumption in the ToxTest-TEH113 study. |
TOTAL ASSESSMENT FACTOR: | 40 | |
DNEL: general population | 3.29 | mg Al/kg bw/day |
6.22 | mg substance/kg bw/day |
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