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EC number: 232-055-3 | CAS number: 7784-25-0
- 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:
- 71.1 mg/m³
- Most sensitive endpoint:
- neurotoxicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
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
Workers - 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
1. Introduction:
In this chapter, all the endpoints from Aluminium ammonium (bis) sulfate are re-examined and analyzed in order to establish a DNEL (s)/DMEL (s) for each one of them if possible. The followed method is that proposed in the guidance for the implementation of Reach (Chapter R.8: Characterisation of dose (concentration)-response for human health, May 2008)
2. Classification in the Annex VI of CLP Regulation (Regulation (EC) N°1272/2008)
Aluminium ammonium (bis) sulfate is not classified according to the Directive 67/548/EC and the CLP Regulation..
3. DNELs/DMELs derivation according to the toxicological profile of Aluminium ammonium (bis) sulfate
Inhalation exposure was the most appropriate route for assessing occupational risk in workers. Dermal exposure is not considered as a relevant route of exposure since Aluminium ammonium (bis) sulfate is not likely to be systematically absorbed by dermal route (see §7.1).
Neither indications of carcinogenic nor reprotoxic potential were observed or expected. Tests assessing the mutagenic potential of Aluminium ammonium (bis)sulfatein vitroandin vivoprovided no evidence of mutagenic or genotoxic activity.
No acute toxicity hazard has been identified and no peak exposure has been predicted for Aluminium ammonium (bis)sulfate, therefore the long-term DNEL by inhalation route ensure a sufficient level of protection. No DNELacutefor inhalation route has been derived.
Calculation of long-term DNEL by inhalation for systemic effects for Aluminium / Worker
The concentration descriptor has been obtained from the combined toxicity study (OECD 426/452) by oral route (see § 7.9.1). Granulometry on the powder of Aluminium ammonium (bis)sulfate showed no detectable particles in the alveolar fraction and a very low percentage of total particulates in the inhalable fraction (<100 µm). These particles are expected to be dissolved by the mucus from the respiratory tract in order to be swalled. Consequently the toxicity by inhalation is warranted due to the potential for oral toxicity and no uncertainty factor is considered for the absorption between the oral route and the inhalation.
Under the test conditions of the chronic neurotoxicity study using Aluminium citrate (considered as a worst-case relevant aluminium salt), neuromuscular effects were observed on male and female rats. The NOAEL in this study is 30 mg Aluminium/kg bw/d.
The following Table 3.1 indicates the inhalation DNEL-long term for systemic effects calculation.
Table 3.1:Calculation of long-term DNEL by inhalation route for systemic effects
Worker |
Long-term DNEL / inhalation / systemic effects |
Step a : determination of the critical dose |
|
Key study |
Combined study OECD 426/452, K2 (read-across) |
Relevant dose descriptor |
NOAEL = 30 mg Al/kg bw/d (rat, oral) for neuromuscular effects (females and males) |
Step b : Correct starting point – factor for uncertainties |
|
Differences in absorption depending on route of exposure (route-route extrapolation, human/animal) |
1 (oral absorption for aluminium sulfate /absorption by inhalation) |
Modification for exposure (experiment in animal and human) |
1/0.38 (standard respiratory volume animal/human) |
Modification for the respiratory volume |
6.7/10 (respiratory rate difference under standard conditions and under conditions of light activity for 8 hours) |
Correct starting point = relevant dose descriptor / overall factor for uncertainties |
52.9 mg Al/m3 |
Step c : assessment factors |
|
Interspecies differences - Differences in metabolic rate per b.w. (allometric scaling)
- Remaining differences
|
- (Not applicable)
2.5 |
Intraspecies differences |
5 (worker) |
Duration extrapolation (sub-acute/sub-chronic/chronic) |
1 (one-year repeated dose toxicity study) |
Issues related to dose-response |
1 |
Quality of the whole database |
1 |
Overall assessment factor |
12.5 |
DNEL calculation |
4.23 mg Al/m3 |
71.1 mg salt/m3* |
*Molecular Weightsalt=906.6 at 20°C
The inhalation DNEL long-term for systemic effects is 71.1 mg salt/m3in the worker. This value corresponds to an exposure of 4.23 mgAl/m3 which is already covered by the indicative occupationnal exposure level (IOEL) of 2 mg Al/m3used in many European countries.
1. Introduction:
In this chapter, all the endpoints from Aluminium ammonium (bis) sulfate are re-examined and analyzed in order to establish a DNEL (s)/DMEL (s) for each one of them if possible. The followed method is that proposed in the guidance for the implementation of Reach (Chapter R.8: Characterisation of dose (concentration)-response for human health, May 2008)
2. Classification in the Annex VI of CLP Regulation (Regulation (EC) N°1272/2008)
Aluminium ammonium (bis) sulfate is not classified according to the Directive 67/548/EC and the CLP Regulation..
3. DNELs/DMELs derivation according to the toxicological profile of Aluminium ammonium (bis) sulfate
Inhalation exposure was the most appropriate route for assessing occupational risk in workers. Dermal exposure is not considered as a relevant route of exposure since Aluminium ammonium (bis) sulfate is not likely to be systematically absorbed by dermal route (see §7.1).
Neither indications of carcinogenic nor reprotoxic potential were observed or expected. Tests assessing the mutagenic potential of Aluminium ammonium (bis)sulfatein vitroandin vivoprovided no evidence of mutagenic or genotoxic activity.
No acute toxicity hazard has been identified and no peak exposure has been predicted for Aluminium ammonium (bis)sulfate, therefore the long-term DNEL by inhalation route ensure a sufficient level of protection. No DNELacutefor inhalation route has been derived.
Calculation of long-term DNEL by inhalation for systemic effects for Aluminium / Worker
The concentration descriptor has been obtained from the combined toxicity study (OECD 426/452) by oral route (see § 7.9.1). Granulometry on the powder of Aluminium ammonium (bis)sulfate showed no detectable particles in the alveolar fraction and a very low percentage of total particulates in the inhalable fraction (<100 µm). These particles are expected to be dissolved by the mucus from the respiratory tract in order to be swalled. Consequently the toxicity by inhalation is warranted due to the potential for oral toxicity and no uncertainty factor is considered for the absorption between the oral route and the inhalation.
Under the test conditions of the chronic neurotoxicity study using Aluminium citrate (considered as a worst-case relevant aluminium salt), neuromuscular effects were observed on male and female rats. The NOAEL in this study is 30 mg Aluminium/kg bw/d.
The following Table 3.1 indicates the inhalation DNEL-long term for systemic effects calculation.
Table 3.1:Calculation of long-term DNEL by inhalation route for systemic effects
Worker |
Long-term DNEL / inhalation / systemic effects |
Step a : determination of the critical dose |
|
Key study |
Combined study OECD 426/452, K2 (read-across) |
Relevant dose descriptor |
NOAEL = 30 mg Al/kg bw/d (rat, oral) for neuromuscular effects (females and males) |
Step b : Correct starting point – factor for uncertainties |
|
Differences in absorption depending on route of exposure (route-route extrapolation, human/animal) |
1 (oral absorption for aluminium sulfate /absorption by inhalation) |
Modification for exposure (experiment in animal and human) |
1/0.38 (standard respiratory volume animal/human) |
Modification for the respiratory volume |
6.7/10 (respiratory rate difference under standard conditions and under conditions of light activity for 8 hours) |
Correct starting point = relevant dose descriptor / overall factor for uncertainties |
52.9 mg/m3 |
Step c : assessment factors |
|
Interspecies differences - Differences in metabolic rate per b.w. (allometric scaling)
- Remaining differences
|
- (Not applicable)
2.5 (remaining differences) |
Intraspecies differences |
5 (worker) |
Duration extrapolation (sub-acute/sub-chronic/chronic) |
1 (one-year repeated dose toxicity study) |
Issues related to dose-response |
1 |
Quality of the whole database |
1 |
Overall assessment factor |
12.5 |
DNEL calculation |
4.23 mg Al/m3 |
71.1 mg salt/m3* |
*Molecular Weightsalt=906.6 at 20°C
The inhalation DNEL long-term for systemic effects is 71.1 mg salt/m3in the worker. This value corresponds to an exposure of 4.23 mgAl/m3 which is already covered by the indicative occupationnal exposure level (IOEL) of 2 mg Al/m3used in many European countries.
(see GESTIS International Limit values: http://bgia-online.hvbg.de/LIMITVALUE/WebForm_ueliste.aspx)
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:
- DNEL (Derived No Effect Level)
- Value:
- 5.04 mg/kg bw/day
- Most sensitive endpoint:
- neurotoxicity
DNEL related information
- Overall assessment factor (AF):
- 100
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
1. Introduction:
In this chapter, all the endpoints from Aluminium ammonium (bis)sulfate are re-examined and analyzed in order to establish a DNEL (s)/DMEL (s) for each one of them if possible. The followed method is that proposed in the guidance for the implementation of Reach (Chapter R.8: Characterisation of dose (concentration)-response for human health, May 2008)
2. Classification in the Annex VI of CLP Regulation (Regulation (EC) N°1272/2008)
Aluminium ammonium (bis)sulfate is not classified according to the Directive 67/548/EC and the CLP Regulation 1272/2008.
3. DNELs/DMELs derivation according to the toxicological profile of Aluminium ammonium (bis) sulfate
Oral exposure was the most appropriate route for assessing occupational risk for humans exposed via the environment. Inhalation exposure is warranted by the DNEL for oral exposure. Dermal exposure is not considered as a relevant route of exposure since Aluminium ammonium (bis)sulfate is not likely to be systematically absorbed by dermal route (see §7.1).
Neither indications of carcinogenic nor reprotoxic potential were observed or expected. Tests assessing the mutagenic potential of Aluminium ammonium (bis)sulfatein vitroandin vivoprovided no evidence of mutagenic or genotoxic activity.
No acute toxicity hazard has been identified and no peak exposure has been predicted for Aluminium ammonium (bis)sulfate, therefore the long-term DNEL by oral route ensure a sufficient level of protection. No DNELacutefor oral route has been derived.
Calculation of long-term DNEL by oral route for systemic effects for Aluminium /Humans exposed via the environment
The concentration descriptor has been obtained from the combined toxicity study (OECD 426/452) by oral route (see § 7.9.1).
Under the test conditions of the chronic neurotoxicity study of Aluminium citrate (considered as a worst-case relevant aluminium salt), neuromuscular effects were observed on male and female rats. The NOAEL in this study is 30 mg Aluminium/kg bw/d.
The following Table 3.1 indicates the oral DNEL-long term for systemic effects calculation.
Table 3.1:Calculation of long-term DNEL by oral route for systemic effects
Humans exposed via the environment |
Long-term DNEL / oral / systemic effects |
Step a :determination of the critical dose |
|
Key study |
Combined study OECD 426/452, K2 (read-across) |
Relevant dose descriptor |
NOAEL = 30 mg Al/kg bw/d (rat, oral) for neuromuscular effects (females and males) |
Step b : Correct starting point – factor for uncertainties |
|
Differences in absorption depending on route of exposure (route-route extrapolation, human/animal) |
1 (same route of exposure ; same absorption between human and animal) |
Modification for exposure (experiment in animal and human) |
- |
Modification for the respiratory volume |
Not applicable |
Correct starting point = relevant dose descriptor / overall factor for uncertainties |
30 mg Al/kg bw/d |
Step c : assessment factors |
|
Interspecies differences - Differences in metabolic rate per b.w. (allometric scaling)
- Remaining differences
|
4
2.5 |
Intraspecies differences |
10 (general population) |
Duration extrapolation (sub-acute/sub-chronic/chronic) |
1 (one-year repeated dose toxicity study) |
Issues related to dose-response |
1 |
Quality of the whole database |
1 |
Overall assessment factor |
100 |
DNEL calculation |
0.3 mg Al/kg bw/d |
5.04 mg salt/kg bw/d* |
*Molecular mass salt = 906.6 g/mol
The oral DNEL long-term for systemic effects is 5.04 mg Salt/kg bw/d for humans exposedviathe environment.
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