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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-135-0 | CAS number: 10043-01-3
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable with restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
- Type of sensitisation studied:
- respiratory
- Study type:
- other: case-control study
- Principles of method if other than guideline:
- Aims: To assess the significance of individual risk factors in the development of occupational asthma of aluminium smelting (OAAS).
Methods: A matched case-control study nested in a cohort of 545 workers employed in areas with moderate to high levels of smelting dust and fume. The cohort comprised those who had their first pre-employment medical examination between 1 July 1982 and 1 July 1995; follow up was until 31 December 2000. Forty five cases diagnosed with OAAS and four controls per case were matched for the same year of pre-employment and age within ±5 years. The pre-employment medical questionnaires were examined, blinded as to case-control status, and information obtained on demographics and details of allergic symptoms, respiratory risk factors, respiratory symptoms, and spirometry. Data from the subsequent medical notes yielded subsequent history of hay fever, family history of asthma, full work history, date of termination or diagnosis, and tobacco smoking history at the end-point. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Aluminium oxide
- EC Number:
- 215-691-6
- EC Name:
- Aluminium oxide
- Cas Number:
- 1344-28-1
- IUPAC Name:
- 1344-28-1
- Test material form:
- aerosol dispenser: not specified
- Remarks:
- migrated information: aerosol
- Details on test material:
- - Name of test material :aluminium oxide
- Molecular formula :Al2O3
- Molecular weight :101.96 g mol−1
- Smiles notation :[Al+3].[Al+3].[O-2].[O-2].[O-2]
- InChl :1/2Al.3O/q2*+3;3*-2
- Structural formula attached as image file : see Fig.1
- Substance type:inorganic
- Physical state:white solid very hygroscopic
- Odor: odorless
- Density: 3.95-4.1 g/cm3
- Melting point: 2072 °C
- Boiling point: 2977 °C
- Solubility in water: insoluble
- Solubility :insoluble in diethyl ether, practically insoluble in ethanol
Constituent 1
Method
- Type of population:
- occupational
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- A matched case-control study nested in a cohort of 545 workers employed in areas with moderate to high levels of smelting dust and fume. The cohort comprised those who had their first pre-employment medical examination between 1 July 1982 and 1 July 1995; follow up was until 31 December 2000. Forty five cases diagnosed with OAAS and four controls per case were matched for the same year of pre-employment and age within ±5 years. The pre-employment medical questionnaires were examined, blinded as to case-control status, and information obtained on demographics and details of allergic symptoms, respiratory risk factors, respiratory symptoms, and spirometry. Data from the subsequent medical notes yielded subsequent history of hay fever, family history of asthma, full work history, date of termination or diagnosis, and tobacco smoking history at the end-point.
- Clinical history:
- To assess the significance of individual risk factors in the development of occupational asthma of aluminium smelting (OAAS).
A matched case-control study nested in a cohort of 545 workers employed in areas with moderate to high levels of smelting dust and fume. The cohort comprised those who had their first pre-employment medical examination between 1 July 1982 and 1 July 1995; follow up was until 31 December 2000. Forty five cases diagnosed with OAAS and four controls per case were matched for the same year of pre-employment and age within ±5 years. - Controls:
- The pre-employment medical questionnaires were examined, blinded as to case-control status, and information obtained on demographics and details of allergic symptoms, respiratory risk factors, respiratory symptoms, and spirometry. Data from the subsequent medical notes yielded subsequent history of hay fever, family history of asthma, full work history, date of termination or diagnosis, and tobacco smoking history at the end-point.
- Route of administration:
- inhalation
- Details on study design:
- Study sample
The cohort consisted of all who had their pre-employment medical examination between 1 July 1982 and 1 July 1995 and commenced their employment in areas with at least weekly exposure to fluoride dust and fume (potrooms, potroom maintenance, pot reconstruction, potroom services, carbon rodding, and rodding maintenance). Follow up was until 31 December 2000.
Selection of cases
The case criteria used were those defined by the Australian Aluminium Council, which is consistent with American Thoracic Society guidelines.20 The criteria were:
• Symptoms of dyspnoea, chest tightness, and/or wheezing, often with cough, which may be brought about by exercise
• A period of initial exposure to fluorides of more than two weeks before symptom onset
• Symptoms temporally related to exposure, but often also nocturnal
• Symptoms improve when the subject is away from work for days or longer.
The symptoms were supported by objective evidence of significant reversible airflow obstruction and/or evidence of BHR on testing.
One respiratory physician diagnosed cases at the smelter between 1982 and 2000. Most cases were detected by regular medical surveillance, however, some cases self-referred. Persons with chronic obstructive disease due to welding or metal fume were excluded.
Selection of controls
Controls, four per case, were matched for age (-+5 years) and same year of commencing employment. Exclusion criteria were any respiratory pathology, significant non-transient respiratory symptoms, being investigated for respiratory pathology, and those employed in an aluminium smelter prior to the original pre-employment.
Data collection
The pre-employment medical questionnaires, examination, and recorded spirometry were examined for all subjects with blinding as to case or control status. Past or present history of hay fever, family history of asthma, past or present history of bronchitis (history of chronic chestiness with associated phlegm), history of asthma before age 15 years, tobacco smoking history at employment (never, ex, and current), past or present history of dermatitis, symptoms of wheeze, and symptoms of regular cough were recorded. Hay fever was defined as seasonal symptoms of itchy, runny nose (allergic rhinitis) with or without associated eye symptoms. Skin testing was not performed.
Physical examination data included height, weight, and ethnicity. Pre-employment spirometric data recorded were the forced vital capacity (FVC), the forced expiratory volume in 1 second (FEV1), and forced expiratory ratio (FER) (100 x FEV1/FVC). Percent predicted values for the FVC and FEV1 were calculated using in-house equations for Europeans, and equations calculated by de Hamel and Welford, for Maoris and Samoans.
Follow up data included hay fever and family history of asthma diagnosed or disclosed after the onset of employment, full work history while at the smelter, and tobacco smoking history at termination, diagnosis, or at the end date of the study. It was assumed that no subjects would develop OAAS after leaving the smelter.
Exposure assessment
Occupational hygiene monitoring provided the mean concentrations of respirable dust, fluorides, and sulphur dioxide in all areas. Exposure was categorised in five levels: potrooms and potroom services, grade 4 (highest risk); pot reconstruction, potroom maintenance, and carbon rodding, grade 3; rodding maintenance, grade 2; metal products and bath and alumina plant, grade 1; and all other areas on site, grade 0. A cumulative exposure index for each individual was calculated by adding the products of the exposure grade and the yearsworked in a specific area.
Statistical analysis
The data were analysed using STATA version 7. Results of the univariate analyses were presented as mean (SD) and proportions. Conditional logistic regression was used to calculate odds ratios and 95% confidence intervals. Adjustment for fluoride exposure was performed by using the exposure index as a continuous variable as well as grade of exposure as a five level categorical variable.
Results and discussion
- Results of examinations:
- There was a significant positive association between hay fever diagnosed either at or during employment and OAAS (adjusted OR 3.58, 95% CI 1.57 to 8.21). A higher forced expiratory ratio (FEV1/FVC%) at employment reduced the risk of developing OAAS (adjusted OR 0.93, 95% CI 0.88 to 0.99). The risk of OAAS was more than three times higher in individuals with an FER of 70.0–74.9% than in individuals with an FER 80.0% (adjusted OR 3.46, 95% CI 1.01 to 11.89).
RESULTS
Demographics
Table 1 summarises the demographic characteristics. The prevalence of hay fever at employment was higher for cases than controls, but both were lower than the general population in New Zealand (35%). The total prevalence for hay fever was higher at 16.9%. Ninety six per cent of individuals reporting a family history of asthma at employment did so in first degree relatives. Tobacco smoking was common at employment, more so in cases than controls (51.1% versus 43.9%). This differential was still present at diagnosis. Of the non-Europeans only one person was not a Maori or Samoan.
Employment and exposure information
The majority of cases, and a lesser majority of controls, were first employed as potroom operators: 91.1% and 73.9% respectively. Of all the cases and controls in the cohort, 209 (92.9%) started work in the potroom area of the plant (potrooms, potroom services, potroom maintenance, and pot reconstruction). This, and matching for year of employment, ensured similar exposures of cases and controls.
The mean (SD) duration of employment was 10.23 (5.53) years, 6.09 (4.04) years for cases (range 0–16 years), and 11.26 (5.38) years for controls (range 2–19 years). Forty three (95.6%) of the cases were still working in potroom areas at diagnosis. The mean exposure index for cases was 21.21 (SD 14.53, range 3–64) and 17.84 (SD 12.64, range 1.5–63) for controls.
Matched analysis for potential individual risk factors
Table 2 summarises the matched analysis for potential individual risk factors for OAAS. The odds ratio (OR) for hay fever at employment was raised, although not significantly, both before and after adjustment for confounders (crude OR 1.65, 95% CI 0.59 to 4.60; adjusted OR 2.28, 95% CI 0.76 to 6.89). Examining ‘‘all hay fever’’ (identified at employment and subsequently) showed a statistically significant increased risk, enhanced by adjustment for confounding. The magnitude of this association increased further on adjusting for smoking at termination or diagnosis as against smoking status at employment (adjusted OR 3.79, 95% CI 1.64 to 8.79). A family history of asthma, history of bronchitis, childhood asthma, and wheeze at pre-employment
revealed increased, but non-significant ORs. There was no significant association between OAAS and tobacco smoking. The remainder of the potential risk factors showed only weak associations. There was a statistically significant negative association between the FER at pre-employment and OAAS (crude OR 0.93, p=0.005; adjusted OR 0.93, p=0.017). Thus for each 1% lower FER at employment the risk of OAAS increased by 7%. In the stratified analysis, there was a significant positive association with an FER of 75.0–79.9% (crude OR 2.22, p=0.038). A pre-employment FER of 70.0–74.9% increased the risk for OAAS further (crude OR 3.35, p=0.026). Individuals with the lowest level of FER (,70.0%) also had an increased risk, but because of the small number (n=4), the finding was not statistically significant (adjusted OR 2.94, 95% CI 0.24 to 36.46, p=0.546).
Any other information on results incl. tables
Table 1 |
Characteristics of the cases and controls in the study |
|||
Characteristic |
Controls (n = 180) |
Cases (n = 45) |
Total (n = 225) |
|
Age (years) |
26.7 (+-6.1) |
26.6 (+-6.3) |
26.7 (+-6.2) |
|
Height (cm) |
176.9 (+-5.9) |
175.9 (+-6.6) |
176.7 (+-6.0) |
|
Weight (kg) |
78.3 (+-11.7) |
79.7 (+-10.4) |
78.6+-11.2) |
|
Body mass index |
25.0 (+-3.23) |
25.77 (+-3.2) |
25.16 (+-3.2) |
|
Ethnicity |
|
|
|
|
Caucasian |
166 (92.2%) |
40 (88.9%) |
206 (91.6%) |
|
Maori/Samoan |
20 (11.1%) |
6 (13.3%) |
26 (11.6%) |
|
Other |
1 (0.6%) |
0 |
1 (0.4%) |
|
Tobacco smoking (at employment) |
|
|
|
|
Never smokers |
79 (43.9%) |
18 (40%) |
97 (43.1%) |
|
Ex smokers |
22 (12.2%) |
4 (8.9%) |
26 ( 11.6%) |
|
Current smokers |
79 (43.9%) |
23 (51.1%) |
102 (45.3%) |
|
Tobacco consumption |
|
|
|
|
None |
101 (56.1%) |
22 (48.9%) |
123 (54.7%) |
|
Light smokers |
10 (5.6%) |
1 (2.2%) |
11 (4.9%) |
|
Moderate smokers |
48 (26.7%) |
17 (37.8%) ` |
65 (28.9%) |
|
Heavy smokers |
21 (11.7%) |
5 (11.1%) |
26 (11.6%) |
|
Smoking at termination or diagnosis |
59 (32.8%) |
19 (42.3%) |
78 (34.7%) |
|
Hay fever at employment |
15 (8.5%) |
6 (13.3%) |
21 (9.5%) |
|
Hay fever (total)* |
24 (13.3%) |
14 (31.1%) |
38 (16.9%) |
|
Familial asthma (at employment) |
18 (10.0%) |
6 (14.3%) |
24 (10.8%) |
|
Familial asthma (total)* |
40 (22.2%) |
12 (26.7%) |
52 (23.1%) |
|
Childhood history of asthma |
2 (1.1%) |
1 (2.2%) |
3 (1.3%) |
|
Previous history of bronchitis |
1 (0.6%) |
1 (2.2%) |
2 (0.9%) |
|
Previous history of dermatitis |
10 (5.6%) |
3 (6.7%) |
13 (5.8%) |
|
Cough at employment |
2 (1.1%) |
0 (0%) |
2 (0.9%) |
|
Wheeze at employment |
3 (1.7%) |
0 (0%) |
0 (0%) |
|
*Total: The sum of people with such a history at the pre-employment examination and those with a subsequent history during their employment at the smelter. |
Table2 |
The association between OAAS and potential individual risk factors |
|||
|
Crude odds ratios |
Adjusted odds ratios* |
Alternative adjusted odds ratios� |
|
Variable studied |
(95% CI) |
(95% CI) |
(95% CI) |
|
Hay fever (at employment) |
1.65 (0.59 to 4.60) |
2.28 (0.76 to 6.89) |
2.66 (0.84 to 8.42) |
|
All hay fever |
2.91 (1.35 to 6.26) |
3.58 (1.57 to 8.21) |
3.32 (1.37 to 8.05) |
|
Family history of asthma (at employment) |
|
|
|
|
Family history of asthma |
1.60 (0.58 to 4.42) |
1.63 (0.57 to 4.69) |
2.23 (0.71 to 7.03) |
|
First degree family history |
1.73 (0.61 to 4.89) |
1.80 (0.61 to 5.33) |
2.25 (0.71 to 7.10) |
|
Numbers of family members |
1.59 (0.80 to 3.13) |
1.60 (0.79 to 3.21) |
1.99 (0.91 to 4.34) |
|
Family history of asthma (at employment and subsequently) |
|
|
|
|
Family history of asthma |
1.29 (0.60 to 2.79) |
1.44 (0.64 to 3.24) |
1.28 (0.55 to 2.97) |
|
First degree family history |
1.40 (0.64 to 3.07) |
1.60 (0.69 to 3.68) |
1.37 (0.58 to 3.25) |
|
Numbers of family members |
1.21 (0.60 to 2.43) |
1.26 (0.61 to 2.61) |
1.07 (0.51 to 2.24) |
|
A history of hay fever and familial asthma |
1.54 (0.71 to 3.35) |
1.94 (0.85 to 4.43) |
2.42 (0.99 to 5.93) |
|
Tobacco smoking |
|
|
|
|
Never smoker |
reference |
reference |
reference |
|
Ex-smoker at employment |
0.81 (0.25 to 2.64) |
0.70 (0.21 to 2.35) |
0.83 (0.24 to 2.84) |
|
Smoking at start of employment |
1.31 (0.64 to 2.69) |
1.29 (0.61 to 2.75) |
1.46 (0.66 to 2.84) |
|
Light smoker |
0.47 (0.06 to 3.98) |
0.43 (0.05 to 3.72) |
0.60 (0.07 to 5.14) |
|
Moderate smoker |
1.62 (0.78 to 3.38) |
1.49 (0.68 to 3.26) |
1.82 (0.82 to 4.03) |
|
Heavy smoker |
1.11 (0.37 to 3.40) |
1.64 (0.50 to 5.43) |
1.23 (0.39 to 4.01) |
|
Smoking at termination of employment or diagnosis |
1.52 (0.77 to 3.00) |
1.70 (0.84 to 3.42) |
1.72 (0.85 to 3.51) |
|
History of bronchitis |
4.00 (0.25 to 63.95) |
3.68 (0.20 to 66.49) |
5.87 (0.31 to 112.00) |
|
History of childhood asthma |
2.00 (0.18 to 22.06) |
3.02 (0.26 to 34.86) |
11.61 (0.63 to 213.84) |
|
History of dermatitis |
1.21 (0.32 to 4.52) |
1.96 (0.49 to 7.84) |
1.79 (0.43 to 7.55) |
|
Maori/Samoan ethnicity |
1.48 (0.50 to 4.34) |
1.42 (0.46 to 4.45) |
1.18 (0.38 to 3.63) |
|
Wheeze on auscultation at pre-employment examination |
4.00 (0.56 to 28.40) |
4.81 (0.65 to 35.44) |
6.55 (0.56 to 77.10) |
|
Being overweight (BMI 25.0–29.9) |
1.13 (0.56 to 2.31) |
1.10 (0.52 to 2.36) |
1.41 (0.60 to 3.28) |
|
Being obese (BMI >30.0) |
2.09 (0.71 to 6.16) |
2.17 (0.68 to 6.87) |
2.82 (0.79 to 10.04) |
|
Spirometric variables |
|
|
|
|
FVC (% of predicted) |
1.01 (0.97 to 1.04) |
1.01 (0.98 to 1.05) |
1.00 (0.96 to 1.04) |
|
FEV1 (% of predicted) |
0.98 (0.95 to 1.01) |
0.99 (0.96 to 1.02) |
0.98 (0.95 to 1.01) |
|
FER (FEV1/FVC %) |
0.93 (0.88 to 0.98) |
0.93 (0.88 to 0.99) |
0.93 (0.88 to 0.99) |
|
Stratified analysis |
|
|
|
|
FER >80.0% |
reference |
reference |
reference |
|
FER 75.0–79.9% |
2.22 (1.05 to 4.72) |
2.05 (0.93 to 4.52) |
3.07 (1.26 to 7.50) |
|
FER 70.0–74.9% |
3.35 (1.15 to 9.75) |
2.62 (0.85 to 8.07) |
3.46 (1.01 to 11.89) |
|
FER ,70.0% |
2.04 (0.20 to 20.56) |
2.09 (0.20 to 21.68) |
2.94 (0.24 to 36.46) |
|
*Adjusted for exposure index, current and ex smoking at employment, and Maori/Samoan ethnicity. |
|
Applicant's summary and conclusion
- Conclusions:
- Individuals with hay fever may be more susceptible to occupational asthma when exposed to airborne irritants in aluminium smelting. The pathological basis may be reduced nasal filtration and increased bronchial hyperresponsiveness
- Executive summary:
- Aims:To assess the significance of individual risk factors in the development of occupational asthma of aluminium smelting (OAAS).Methods:A matched case-control study nested in a cohort of 545 workers employed in areas with moderate to high levels of smelting dust and fume. The cohort comprised those who had their first pre-employment medical examination between 1 July 1982 and 1 July 1995; follow up was until 31 December 2000. Forty five cases diagnosed with OAAS and four controls per case were matched for the same year of pre-employment and age within ±5 years. The pre-employment medical questionnaires were examined, blinded as to case-control status, and information obtained on demographics and details of allergic symptoms, respiratory risk factors, respiratory symptoms, and spirometry. Data from the subsequent medical notes yielded subsequent history of hay fever, family history of asthma, full work history, date of termination or diagnosis, and tobacco smoking history at the end-point.Results:There was a significant positive association between hay fever diagnosed either at or during employment and OAAS (adjusted OR 3.58, 95% CI 1.57 to 8.21). A higher forced expiratory ratio (FEV1/FVC%) at employment reduced the risk of developing OAAS (adjusted OR 0.93, 95% CI 0.88 to 0.99). The risk of OAAS was more than three times higher in individuals with an FER of 70.0–74.9% than in individuals with an FERConclusions:Individuals with hay fever may be more susceptible to occupational asthma when exposed to airborne irritants in aluminium smelting. The pathological basis may be reduced nasal filtration and increased bronchial hyperresponsiveness
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.