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EC number: 221-394-2 | CAS number: 3085-30-1
- 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
Endpoint summary
Administrative data
Description of key information
Upon contact with water or moisture (e.g. within mucous membranes) aluminium tributanolate hydrolyses immediately to butan-1ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species
A test following the protocol of OECD 429 was performed in mice treated with 5, 10 and 25% of butan-1-ol in distilled water during 3 consecutive days (Ryan 2000). On day 5 animals were treated with 3H-methylthymidine and the amount of 3H-TdR was measured in a cell suspension derived from the auricular lymphnodes (pooled/animal). The stimulation index was 1.6, 1.2 and 1.4 at 5, 10 and 25%. This is indicative for no sensitizing effects.
Basketter (1999) investigated the allergenic potential of a.o. aluminium chloride hexahydrate (5, 10 and 25% in petrolatum) in the Local Lymph Node Assay (LLNA). Groups of 4 CBA/Ca mice (7 to 12 weeks of age) were treated with 25 μL of substance or with an equal volume of the vehicle alone, on the dorsum of both ears. The mice were treated once daily for 3 days. Two days later, the mice were injected with 250 μL of phosphate buffered saline (PBS) with 20 μCi of tritiated thymidine (2 Ci mmol-l). The mice were killed 5 hours later and a single-cell suspension of lymph node cells was prepared by mechanical disaggregation. Aluminium chloride hexahydrate did not induce a lymph node proliferation response compared to concurrent vehicle-treated controls, and therefore the response was judged as negative. The results of this study add to the weight of evidence for a low sensitisation potential of aluminium 3+ cations.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- 100%
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley Inc, Indianapolis IN, USA
- Age at study initiation: 6-12 weeks
- Weight at study initiation: no data
ENVIRONMENTAL CONDITIONS: no data
Animals were housed, fed and handled according to the USA Animal Welfare Act - Vehicle:
- other: distilled water
- Concentration:
- 0, 5, 10 and 20% v/v
- No. of animals per dose:
- 5 females
- Details on study design:
- PRE-SCREEN TESTS: no data on pre-test and selection of the doses
MAIN STUDY:
Mice were treated for 3 consecutive days with 25 uL of the concentration at the dorsal site of the ears. After 5 days mice were injected with 3H-methylthymidine in PBS (20 uCi). Five hours thereafter mice were euthanised and draining auricular lymphnodes were removed (pooled per animal) and single cell suspensions were prepared by mechanical disaggregation through a nylon mesh (100 um pore size). Cell suspension were washed, precipitated with TCA and left overnight (at 4 degr C). After further preparation and suspension in scintillation cocktail the 3H-methylthymidine incorporation was measured by beta-scintillation counting (expressed as DPM/mouse) - Positive control substance(s):
- other: the test contained several substances with positive results
- Statistics:
- NA
- Parameter:
- other: DPM
- Value:
- 366
- Variability:
- ± 44
- Test group / Remarks:
- control
- Remarks on result:
- other: SI =1
- Parameter:
- other: DPM
- Value:
- 598
- Variability:
- ± 157
- Test group / Remarks:
- 5% group
- Remarks on result:
- other: SI = 1.6
- Parameter:
- other: DPM
- Value:
- 451
- Variability:
- ± 17
- Test group / Remarks:
- 10% group
- Remarks on result:
- other: SI = 1.2
- Parameter:
- other: DPM
- Value:
- 530
- Variability:
- ± 91
- Test group / Remarks:
- 25% group
- Remarks on result:
- other: SI = 1.4
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- control
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 20%
- Cellular proliferation data / Observations:
- No additional data available
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not sensitizing in the LLNA test
- Executive summary:
A test following the protocol of OECD 429 was performed in mice treated with 5, 10 and 25% of the substance in distilled water during 3 consecutive days. On day 5 animals were treated with 3H-methylthymidine and the amount of 3H-TdR was measured in a cell suspension derived from the auricular lymphnodes (pooled/animal). The stimulation index was 1.6, 1.2 and 1.4 at 5, 10 and 25%. This is indicative for no sensitizing effects.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- :
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Species and strain: mouse, 4 CBA/Ca
Source: Harlan Olac, Bicester, UK.
Justification of species and strain: Mouse is the preferred animal for this test (OECD TG#429)
Sex: not stated
Body weight range at the beginning of the study: not stated
Age at testing: 7 to 12 weeks
No further details mentioned - Vehicle:
- other: petrolatum
- Concentration:
- 5.0%, 10.0%, and 25.0%
- No. of animals per dose:
- 4
- Details on study design:
- Two days after the last exposure, the mice were injected with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of tritiated thymidine (from Amersham International, Amersham, UK). Five hours later, the mice were killed, draining lymph nodes excised and a single-cell suspension of the pooled lymph node samples was prepared.
The lymph node cell suspension was washed in excess PBS, precipitated with 5% trichloroacetic acid (TCA) at 4 ºC for 18 hours. After resuspension in TCA, β-scintillation counting was used to measure tritium incorporation.
The method used to kill the animals was not reported.
Observations:
Proliferation of cells in the lymph nodes.
- A positive result was defined as a threefold or greater proliferation than in the concurrent vehicle treated controls. - Positive control substance(s):
- other: positive results were seen for metal salts of gold, beryllium, cobalt, mercury, platinum and tin that were tested in parallel
- Statistics:
- NA
- Positive control results:
- positive responses were noted
- Key result
- Parameter:
- SI
- Value:
- >= 0.7 - <= 0.8
- Test group / Remarks:
- 5% 0.8; 10% 0.8; 25% 0.7
- Parameter:
- EC3
- Remarks on result:
- not determinable
- Remarks:
- all values SI values < 3
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 25
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Aluminium chloride hexahydrate did not show sensitizing potential under the conditions used in this assay.
- Executive summary:
Basketter et al. (1999) investigated the allergenic potential of 13 metal salts including aluminium chloride hexahydrate (99% purity) in the Local Lymph Node Assay (LLNA). Groups of 4 CBA/Ca mice (7 to 12 weeks of age) were treated with 25 μL of substance or with an equal volume of the vehicle alone, on the dorsum of both ears. The mice were treated once daily for 3 days. Two days later, the mice were injected with 250 μL of phosphate buffered saline (PBS) with 20 μCi of tritiated thymidine (2 Ci mmol-l). The mice were killed 5 hours later and a single-cell suspension of lymph node cells was prepared by mechanical disaggregation. A substance was considered a skin sensitizer the proliferation in the lymph nodes of treated mice was 3-fold or greater than that in the concurrent vehicle-treated controls. Aluminium chloride hexahydrate administered in petrolatum (vehicle) at test concentrations of 5.0%, 10.0% and 25.0% did not induce a lymph node proliferation response compared to concurrent vehicle-treated controls, and therefore the response was judged as negative. The results of this study add to the weight of evidence for a low sensitisation potential of aluminium 3+ cations.
Referenceopen allclose all
The results for aluminium chloride hexahydrate were negative. There was no information on the irritancy of the tested concentration from a pre-test
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
None of the hydrolysis products is expected to cause sensitization of the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the outcome of the studies with both hydrolysis products of aluminium tributanolate, the substance has not to be classified for sensitizing properties according to Regulation EC 1272/2008.
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