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Diss Factsheets

Administrative data

Description of key information

Studies in one nanoform of Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) as well as in the read-across substance Silicic acid, aluminum magnesium sodium salt (CAS 12040-43-6, SMAS) did not reveal any skin sensitisation potential.


There is no data on respiratory sensitisation available, but there is no evidence for it after decades of experience with exposed workers.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
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
Conclusions:
The test item Silicic acid Aluminium Magnesium Sodium Salt was not a skin sensitiser under the test conditions of this study.
Executive summary:

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 by topical application to the dorsum of each ear for three consecutive days.


Silicic acid Aluminium Magnesium Sodium Salt was not assessed as a skin sensitiser.

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
experimental phase: Jul. 16, 2016 - Sep. 19, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: DB-ALM Protocol No. 36
Deviations:
not specified
GLP compliance:
yes
Type of study:
human Cell Line Activation Test (h-CLAT)
Specific details on test material used for the study:
Sodasil P95
Details of test system:
other: THP-1 human monocytic leukemia cell line
Details on the study design:
THP-1 cellular line was cultured in RPMI 1640 medium with 2 mM glutamine, 10% FBS, 0.05 mM 2-Mercaptoethanol and 100 U/mL penicillin and 100 μg/mL streptomycin and cultured at 37ºC under 5% CO2 and humidified atmosphere.
The solvent for disperse the test items 0.05% BSA in saline was used as negative control.
A total five concentrations were prepared for a preliminary concentration-range finding assay and measurement of the CD86/CD54 expression. In this case, the maximum dose evaluated for the test item was the highest soluble concentration with a dilution factor 1:2.
Vehicle / solvent control:
saline [442E]
Positive control:
other: NiSO4 at a final concentration of 200 μg/mL was used as positive control for the preliminary assay and DNCB at a final concentration of 4 μg/mL was used as positive control for measurement of CD86/CD54 expression.
Key result
Group:
test chemical
Parameter:
RFI CD54>150 [442E]
Value:
0.61 µg/mL
Cell viability:
95.5 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Parameter:
RFI CD54>150 [442E]
Value:
0.73 µg/mL
Cell viability:
95.0 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Parameter:
RFI CD54>150 [442E]
Value:
0.88 µg/mL
Cell viability:
94.7 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Parameter:
RFI CD54>150 [442E]
Value:
1.06 µg/mL
Cell viability:
95.0 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Parameter:
RFI CD54>150 [442E]
Value:
1.27 µg/mL
Cell viability:
95.3 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Group:
other: solvent control
Parameter:
RFI CD54>150 [442E]
Value:
0 µg/mL
Cell viability:
93.9 %
Vehicle controls validity:
not applicable
Positive controls validity:
valid
Key result
Group:
test chemical
Parameter:
RFI CD86>200 [442E]
Value:
0.61 µg/mL
Cell viability:
95.4 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Parameter:
RFI CD86>200 [442E]
Value:
0.73 µg/mL
Cell viability:
94.5 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Parameter:
RFI CD86>200 [442E]
Value:
0.88 µg/mL
Cell viability:
94.4 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Parameter:
RFI CD86>200 [442E]
Value:
1.06 µg/mL
Cell viability:
94.7 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Group:
test chemical
Parameter:
RFI CD86>200 [442E]
Value:
1.27 µg/mL
Cell viability:
95.0 %
Vehicle controls validity:
valid
Positive controls validity:
valid
Group:
other: solvent control
Parameter:
RFI CD86>200 [442E]
Value:
0 µg/mL
Cell viability:
95.3 %
Vehicle controls validity:
not applicable
Positive controls validity:
valid

Concentrations tested were selected in accordance to the CV75 value. The assays focused on the h-CLAT method applying the test items on THP-1 cells allowed no apparent sensitization potential (i.e. negative response of CD86 and CD54) keeping an appropriate cell viability according to the mean data.

Conclusions:
No sensitization capacity could be observed for Sodasil P95 when assayed under the experimental conditions.
Executive summary:

The aim of this study was to carry out an in vitro test battery with different cell lines addressed to the determination of the basal cytotoxicity, genotoxicity, acute ocular irritation, sensitization and inflammation potentials and bioavailability of eight nanosilicates in order to provide a comprehensive knowledge of the safety profile of these test items. Only the experiments in skin sensitisation with Sodasil P95 are documented here.
Sodasil P95 was unable to induce any sensitization signal on CD86 and CD54 in THP-1 cells after exposure at ranges comprised between 0.61 and 1.27 μg/mL.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Approximately 20 years of cumulative experience in the production of synthetic amorphous Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) have not produced a single case of suspected contact allergy (cf. 7.10.4 Evonik 2009). Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) like synthetic amorphous silica (SAS) is known to result in drying and possibly cracking of the skin. Following prolonged exposure, this was associated with eczematous skin changes.


The implementation of technical measures resulted in a steady reduction of exposure over years. Furthermore, strict personal skin protection, as well as skin care, succeeded in almost eliminating any case of silicate-related skin irritation (Küppers and Ostendorf 2009).


cf. section 7.10.4

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data is available, but there is no evidence for respiratory sensitization after decades of experience with exposed workers.

Justification for classification or non-classification

As no adverse effects were observed, there is no need for classification.