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Diss Factsheets
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EC number: 932-420-3 | 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
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 269 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 269 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- NOAEC
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
Workers - Hazard for the eyes
Additional information - workers
Long-term DNEL Derivations (worker) for local and systemic inhalation exposure:
Substance : read-across from Aluminium hydroxide
Key Studies for Dose Descriptor
Pauluhn (2009a) is considered the most adequate study from which to obtain a dose descriptor for the basis of a DNEL for repeated dose toxicity (inhalation, local effect) for aluminium hydroxide.
The LOAEC from Pauluhn (2009a), a subacute inhalation study, is 28 mg/m3 for a critical effect of focal septal collagen and a persistent increase in PMNs. The NOAEC from Pauluhn (2009a) is 3 mg/m3. There were no dose levels in the study between 3 and 28 mg/m3.The calculation for Pauluhn (2009a) was provided earlier.
For Alag, due to the granulometry and the chemical composition, the derived LOAEC is 50008 mg/m3, and the derived NOAEL is 5358 mg/m3 (see section 7.5).
Long-term DNEL derivation for Alag based on Pauluhn et al. (2009) study :
KEY REFERENCE: Pauluhn J. Pulmonary toxicity and fate of agglomerated 10 and 40 nm aluminium oxyhydroxides following 4-week inhalation exposure of rats: Toxic effects are determined by agglomerated, not primary particle size. Toxicol Sci 2009; 109(1): 152-167. |
||
TEST ANIMAL: |
Wistar rats (male) |
|
TEST SUBSTANCE: |
Aluminium oxyhydroxide (AlO(OH)) |
|
EXPOSURE ROUTE/MEDIUM/ CONCENTRATION/DURATION |
Inhalation/ agglomerates of nanosized particulates AlO(OH)-40 (MMAD = 0.6 μm) and AlO(OH)-10 (MMAD = 1.7μm)/ 0, 0.4, 3 and 28 mg/m3 AlO(OH)/ 6 hrs per day, 5 days per week, 4 weeks [subacute duration] |
|
CRITICAL EFFECT: |
Focal septal collagen that did not regress (but did not progress) post-exposure; persistent elevation of polymorphonuclear neutrophilic granulocytes. |
|
MODE OF ACTION: |
Threshold (portal of entry - overload) |
|
DOSE-DESCRIPTOR: |
5358 |
mg/m3(LOAEC) |
MODIFYING FACTORS: |
|
|
Daily exposure duration experiment) |
6 |
6 hours per day, 5 days per week. |
Daily exposure duration (target population) |
8 |
8 hours per day, 5 days per week |
Inhalatory volume ( experiment) |
6.7 |
Inhalatory volume (rat): 6.7 m3(8h). |
Inhalatory volume (target population) |
10 |
Inhalatory volume (human): 10 m3(8h) |
Bioavailability differences between test and target species: |
1 |
No evidence suggesting that there would be a difference between animal species with respect to actual bioavailability. |
TOTAL MODIFYING FACTOR: |
0.503 |
|
Corrected Starting Point: |
2695 |
mg/m3 |
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: |
5 |
Default for workers (ECHA Guidance, Chapter R8, p34) |
Duration of exposure: |
1 |
Local threshold effect; further adjustment for time-scaling is not considered justified. |
Dose-response extrapolation: |
2 |
Based on a LOAEC; but a suite of very sensitive endpoints were measured in this study; the critical effect was not severe; the inflammatory effects showed reversibility and the focal septal collagen did not show progression post-exposure. |
Adequacy of database: |
1 |
The key study was GLP with 3 months of follow-up; sufficient to see the reversibility of observed effects. |
TOTAL ASSESSMENT FACTOR: |
10 |
|
|
269 |
mg/m3substance, daily 8 hour TWA (respirable) |
Ratio of inhalation bioavailabilities – test: target |
1
|
1
|
Long-term DNEL: |
269 |
mg/m3Substance, daily 8 hour TWA (respirable) |
Short-term DNEL Derivation (worker and consumer):
According to the granulometry and the composition of the substance, the amount of the soluble fraction of aluminium species will be too low in the alveoli. Therefore, no short-term DNEL by inhalation can be reasonably derived for worker and consumer
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
General population is not supposed to be exposed to Alag, while processed. Some short term exposure by dermal or inhalation route could be expected at very low level when people are working for their own. Therefore no adverse effect could be expected in the general population.
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