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EC number: 215-691-6
CAS number: 1344-28-1
NOAECcorr = NOAECinhal * (6 h/d / 8 h/d) * (6.7 m³ (8h)/10 m³ (8h)) = 75
* 0.75 * 0.67 = 37.7 mg/m³
The inhalatory NOAEC was corrected for the difference between
respiratory rates under standard conditions and under conditions of
light activity. Furthermore the inhalatory NOAEC was corrected for
differences in the experimental and human exposure conditions.
Please refer to Additional information - general population.
NOAECcorr = NOAECinhal * (6 h/d / 24 h/d) * = 75 * 0.25 = 18.75 mg/m³
The inhalatory NOAEC was corrected for differences in the experimental
and human exposure conditions.
NOAELcorr = NOAEL * 4.39 = 30 mg Al/kg bw/day * 4.39 = 131.67 mg Al/kg
Modification of starting point to adjust ratios of the whole Al body
fractional uptake for aluminium citrate (0.079%) to the whole body
fractional uptakes of aluminium oxide (0.018%; Atomic Energy of Canada
DNELs have been derived due to effects noted in the available toxicity
studies. As a result of the hazard assessment it is found, that the
substance aluminium oxide does not meet the criteria for classification
according to Regulation (EC) No. 1272/2008. An exposure assessment and
risk assessment is therefore not required according to REACH Article
14(4) and as outlined in the ECHA Technical Guidance Part B: Hazard
Assessment (B.8, Version 2.1, December 2011).
Key Studies for Dose Descriptor Inhalation Long-term:
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 75 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: 75 mg/m³, NOAEC
Test Animal: Rat
Test substance: aluminium oxide - mean particle size diameters: 0.8 μm
Doses used: 0, 30 and 75 mg/m³
Duration of exposure in the experiment: 6 months (for 75 mg/m³) and 12
months (for 30 mg/m³); 6 hours per day, 5 days per week; follow-up to 30
Effects observed: Dust-filled macrophages; no alveolar proteinosis,
endogenous lipid pneumonitis or fibrosis.
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”
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 based on a dosimetric threshold and related to volumetric overloading
Key Study for Dose Descriptor Oral Long-term:
The long-term DNEL for systemic effects via the oral routes is based on
a chronic 1-year oral study with the read-across substance aluminium
citrate (ToxTest. Alberta Research Council Inc., 2010). The GLP study
was designed “to develop data on the potential functional and
morphological hazards to the nervous system that may arise from pre-and
post-natal exposure to aluminium citrate”. In terms of hazard assessment
of toxic effects, available data on the toxicity to
reproduction/development of other aluminium compounds was taken into
account by read-across following a structural analogue approach, since
the pathways leading to toxic outcomes are likely to be dominated by the
chemistry and biochemistry of the aluminium ion (Al3+) (Krewski et al.,
2007). The oral NOAEL for female and male rats was found to be 30 mg
Al/kg bw/day. However, this was already a conservative assumption as the
effects observed could have been secondary to kidney toxicity based on a
crystallisation of aluminium citrate in the kidneys after chronic
exposure and/or reduced body weight and not directly Al-related.
Key Study: Developmental and One-Year Chronic Neurotoxicity Study of
Aluminium Citrate in Rats. ToxTest, Alberta Research Council Inc.
Project No. TEH-113.
Dose Descriptor: NOAEL - 30 mg Al/kg bw/day
Test substance: aluminium citrate
Doses used: 30, 100 and 300 mg Al/kg bw/day
Duration of exposure in the experiment: Pregnant females were exposed to
aluminium citrate from GD6 to GD21 and from PND 1 to PND 21. Pups were
exposed to aluminium citrate in utero and with maternal milk from PND 1
to PND 21, 64, 120 or 364.
Effects observed: A deficit in footsplay- and hind-limb grip strength in
the mid-dose group, supported by evidence of dose response for this
endpoint after chronic exposure.
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