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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 234-919-5 | CAS number: 12040-43-6
- 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
Skin sensitisation
Silicic acid Aluminium Magnesium Sodium Salt was not a skin sensitiser under the test conditions of OECD 429. (Key, Roth, 2015, OECD 429, SMAS, RL1)
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Identification: Silicic acid Aluminium Magnesium Sodium Salt
Batch: code # 1107274003
Purity: > 99%
Appearance: White powder
Expiry Date: November 01, 2018
Storage Conditions: (provided by the Sponsor) At room temperature, moisture protected
Stability: Stable a room temperature
Stability in Solvent: Stable in DMSO - Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- The animals were kept conventionally. The experiment was conducted under standard laboratory conditions.
Housing: group
Cage Type: Makrolon Type II (pre-test) / III (main study), with wire mesh top
Bedding: granulated soft wood bedding
Feed: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
Water: tap water, ad libitum
Environment: temperature 22 ± 2°C relative humidity approx. 45-65% artificial light 6.00 a.m. - 6.00 p.m. - Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0.5, 1, and 2.5% (w/w)
- No. of animals per dose:
- 4
- Details on study design:
- In order to study a possible skin sensitising potential of Silicic acid Aluminium Magnesium Sodium Salt, three groups each of four female mice were treated once daily with the test item at concentrations of 0.5, 1, and 2.5% (w/w) in DMSO by topical application to the dorsum of each ear for three consecutive days. The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by two pre-experiments. A control group of four mice was treated with the vehicle (DMSO) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a β-scintillation counter.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 1.13, 1.16, and 0.96 were determined with the test item at concentrations of 0.5, 1, and 2.5% (w/w) in DMSO.
The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3. - Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 0.0 % (w/w) (control group)
- Key result
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- 0.5 % (w/w)
- Key result
- Parameter:
- SI
- Value:
- 1.16
- Test group / Remarks:
- 1.0 % (w/w)
- Key result
- Parameter:
- SI
- Value:
- 0.96
- Test group / Remarks:
- 2.5 % (w/w)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Test item concentration % Measurement DPM DPM per lymph node 0 9914 1236.9 0.5 11222 1400.4 1 11523 1438.1 2.5 9512 1186.1
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item Silicic acid Aluminium Magnesium Sodium Salt was not a skin sensitiser under the test conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The study performed with SMAS (Roth, 2015, OECD 429, SMAS) did not sensitize any animals, therefore the substance was considered not skin sensitizing.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Although no study specifically on respiratory sensitisation is available, one on acute inhalation did not found any item-related effects during the inhalation exposure and observation period in the male and female test animals. (Stahl, 2012, sim. OECD 403, SMAS)
Furthermore, due to the mass median aerodynamic diameter (MMAD) of the test item Silic acid Aluminium Magnesium Sodium Salt of more than 10µm no respiration is expected.
Experimental studies/investigations about the exposure during the application/production give no hint that dust of the test item is respired by the applicants/workers
Justification for classification or non-classification
As no hazard was identified, there is no need for classification or labelling as skin or respiaratory sensitising agent.
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.