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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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 July - 24 August 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline 429 without any deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Aluminium sulphate
- EC Number:
- 233-135-0
- EC Name:
- Aluminium sulphate
- Cas Number:
- 10043-01-3
- Molecular formula:
- Al.3/2H2O4S
- IUPAC Name:
- Aluminium sulphate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Aluminium sulphate
- Physical state: White flaky powder
- Storage condition of test material: At room temperature in the dark
- Stability under storage conditions: Stable
Constituent 1
- Specific details on test material used for the study:
- - Stability at higher temperatures: Yes, maximum temperature: 600 °C; Thermal decomposition starts at 600 °C
- Stability in vehicle (water): Yes, > 24 h
- Solubility in vehicle (water): 62,9g/100g
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J strain
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France.
- Age at study initiation: Approximately 9 weeks
- Weight at study initiation: 20-25 g
- Housing: Animals were housed individually in labeled Macrolon cages (Ml type; height 12.5 cm) containing sterilized sawdust as bedding material.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiaten GmbH, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C (actual range: 21.5-24.1 °C)
- Humidity: 40-70 % (actual range: 41-78 %)
- Air changes: Approximately 15 air changes per hour
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: 29 July 2009 To: 24 August 2009
Study design: in vivo (LLNA)
- Vehicle:
- other: Water with 1 % pluronic L92
- Concentration:
- Preliminary irritation study: 25 and 50 % w/w
Main study: 10, 25 and 50 % w/w - No. of animals per dose:
- Preliminary irritation study: One animal/dose
Main study: Five animals/dose - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Solubility in vehicle (water): 62.9 g/100 g
- One animal/dose was treated at concentrations of 25 and 50 % w/w on three consecutive days. Approximately 3-4 h after the last exposure, the irritation of the ears was assessed. Bodyweights were determined on Day 3. The animals were sacrificed after the final observation and no necropsy was performed.
- Irritation: No irritation was observed in any of the animals examined. Based on the results, the highest test substance concentration selected for the main study was a 50 % concentration.
MAIN STUDY
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: If the results indicate a Stimulation Index (SI) ≥ 3, the test substance may be regarded as a skin sensitizer, based on the test guideline and recommendations done by ICCVAM. Consideration was given to the EC3 value (the estimated test substance concentration that will give a SI =3).
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance formulations (w/w) were prepared within 4 h prior to each treatment. Homogeneity was obtained to visually acceptable levels by adjusting the pH (pH 3 - 5). 25 µL of control or test item were applied to the dorsal surface of both ears on Days 1, 2 and 3. Each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS) containing 20 μCi of 3H-methyl thymidine on Day 6. After approximately five hours, all animals were killed by intraperitoneal injection with Euthasol 20 % (AST Farma BV, Oudewater, The Netherlands) and the draining (auricular) lymph node of each ear was excised. The relative size of the nodes (as compared to normal) was estimated by visual examination and abnormalities of the nodes and surrounding area were recorded. The nodes were pooled for each animal in approximately 3 mL PBS. A single cell suspension of lymph node cells (LNC) was prepared in PBS by gentle separation through stainless steel gauze (diameter 125 mm). LNC were washed twice with an excess of PBS by centrifugation at 200g for 10 minutes at 4 °C. To precipitate the DNA, the LNC were exposed to 5 % trichloroacetic acid (TCA) stored in the refrigerator until the next day. On Day 7, precipitates were recovered by centrifugation, re-suspended in 1 mL TCA and transferred to 10 mL of Ultima Gold cocktail scintillation fluid. Radioactive measurements were performed using a Packard scintillation counter (2800TR). Counting time was to a statistical precision of ± 0.2 % or a maximum of 5 minutes whichever came first. The scintillation counter was programmed to automatically subtract background and convert Counts Per Minute (CPM) to Disintegrations Per Minute (DPM).
DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No data.
Results and discussion
- Positive control results:
- The six monthly reliability check with Hexylcinnamaldehyde, indicates that the Local Lymph Node Assay as performed at the laboratory is an appropriate model for testing for contact hypersensitivity. At 25 % Hexylcinnamaldehyde, DPM/group and SI/group were 740 and 3.2, respectively.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 10 % test item group
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- 25 % test item group
- Key result
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- 50 % test item group
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- vehicle control group
- Parameter:
- SI
- Value:
- 3.2
- Test group / Remarks:
- positive control group
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 202
- Test group / Remarks:
- 10 % test item group
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 378
- Test group / Remarks:
- 25 % test item group
- Key result
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 109
- Test group / Remarks:
- 50 % test item group
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 231
- Test group / Remarks:
- vehicle control group
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 740
- Test group / Remarks:
- positive control group
Any other information on results incl. tables
Main study:
Skin reactions/irritation: No irritation of the ears was observed in the control animals, the animals treated at 10 % and 25 % and in three animals treated at 50 %. The slight irritation as seen in two animals treated at 50 % and the slight to well-defined irritation as displayed by the positive control animals was considered not to have a toxicologically significant effect on the activity of the nodes.
Macroscopy of the auricular lymph nodes and surrounding area:
All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size, except for one extremely large left node in one experimental animal treated at 10 %. Since this animal also showed abnormalities of the left eye (dull appearance), this animal was rejected from the study and the results were not used for interpretation. No macroscopic abnormalities of the area surrounding the nodes were noted in any of the animals.
Body weights:
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period except for the slight body weight loss as shown by the rejected animal with the abnormality at the left eye.
Toxicity and mortality:
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these test conditions, Aluminium sulphate is not classified as a skin sensitiser according to the Regulation (EC) N°1272-2008 (CLP) and to the GHS.
- Executive summary:
In a local lymph node assay performed according to OECD Guideline 429 and in compliance with GLP, groups of CBA/J mice (5 females/dose) were treated with Aluminium sulphate at concentrations of 10, 25 and 50 % on three consecutive days, by open application on the ear (25 µL/ear). Five vehicle control animals were treated with vehicle alone (1% aqueous L92) and five positive controls were treated with Hexylcinnamaldehyde (25 %). Three days after the last exposure, all animals were injected with 3H–methyl thymidine and after five hours the draining (auricular) lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index (SI) was subsequently calculated for each group. Animals were observed for mortality, clinical signs and body weight during the study. The test concentrations for the main study were determined from a preliminary irritation study at 25 and 50 % using one female/dose.
No mortality and no clinical signs were observed during the observation period. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. No irritation of the ears was observed in the control animals, the animals treated at 10 % and 25 % and in three animals treated at 50 %. The slight irritation was seen in two animals treated at 50 % and the slight to well-defined irritation as displayed by the positive control animals was considered not to have a toxicologically significant effect on the activity of the nodes. All auricular lymph nodes of the animals of the experimental and control groups were considered normal in size, except for one extremely large left node in one experimental animal treated at 10 %. Since this animal also showed abnormalities of the left eye (dull appearance), this animal was rejected from the study and the results were not used for interpretation. No macroscopic abnormalities of the area surrounding the nodes were noted. The median DPM values for the experimental groups treated with test substance concentrations 10, 25 and 50 % were 202, 378 and 109, respectively. The median DPM values for the vehicle and positive control groups were 231 and 740, respectively. The SI values calculated for the substance concentrations 10, 25 and 50 % were 0.9, 1.6 and 0.5, respectively. SI values calculated for vehicle and positive control groups were 1.0 and 3.2, respectively. The SI of the positive control (α- hexylcinnamaldehyde) was > 3; this experiment was therefore considered valid.
Under these test conditions, Aluminium sulphate is not classified as a skin sensitiser according to the Regulation (EC) N°1272-2008 (CLP) and to the GHS.
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.
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