Silicic acid, aluminum magnesium sodium salt

Endpoint summary

Description of key information

Oral:

Silicic acid, aluminium magnesium sodium salt

LD50: > 2000 mg/kg bw for rats (Key, Colas, 2009, OECD 423, SMAS, RL1)

In accordance with the OECD guideline 423, the LD50 cut-off of the test item may be considered higher than 5000 mg/kg bw by oral route in the rat.

Inhalation:

Silicic acid, aluminium magnesium sodium salt

In accordance with the OECD guideline 403, the LC50 of the test item is higher than 5.221 mg/l aerosol concentration by inhalation route in the rat . (Key, Stahl, 2012, sim. OECD 403, SMAS, RL1)

Dermal:

Silicic acid, aluminium magnesium sodium salt

LD50: > 2000 mg/kg bw for wistar rats (Key, Hozova, 2016, OECD 402, SMAS, RL1)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24.02. - 11.03.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

resp. EU method B1.tris

GLP compliance:

yes (incl. QA statement)

Remarks:

Groupe Interministeriel Des Produits Chimiques, 75572 Paris Cedex 12, France

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): Silicic acid Aluminium Magnesium Sodium salt
- Physical state: White powder
- Analytical purity: >99%
- Lot/batch No.: 901274002
- Expiration date of the lot/batch: 26 January 2011
- Production date: 27 January 2009
- Storage condition of test material: Room temperature

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 186 - 202 g
- Fasting period before study: Food was removed at D-1 and then redistributed 4 h after test item administration.
- Housing: by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; each cage contains sawdust bedding which was changed at least 2 times a week; each cage was installed in conventional airconditioned animal husbandry.
- Diet: ad libitum (M20, rat/mouse maintenance, made from the formulation EXTRALABO from PIETREMENT)
- Water: ad libitum (tap water from public distribution system, microbiological and chemical analyses carried out every six months by the Institut europeen de l'Environnement de Bordeaux)
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approx. 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 h continuous light (7:00 to 19:00)/12 hours darkness

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

single dose of 2000 mg/kg bw

No. of animals per sex per dose:

6 (3 animals in Step 1, 3 animals in Step 2), 3 control animals

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations (symptoms, mortality); weighings on D0, D2, D7 and D14
- Necropsy of survivors performed: yes

Statistics:

no data

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Sex:

female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

other: deduced from LD0 value

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs related to the administration of the test item were observed.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

RL1

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

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:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

not specified

GLP compliance:

yes

Remarks:

Hungarian GLP Regulations: 9/2001

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Test item: Silic acid Aluminium Magnesium Sodium salt
Batch No.: 1107274003
Appearance: White powder
Composition: Silic acid Aluminium Magnesium Sodium salt
CAS No.: 12040-43-6
Einecs No.: 234-919-5
Molecular formula: not stated
Purity: > 99 %
Date of production: July 2011
Expiry date: November 2018
Store: at room temperature 20 ± 5°C, dry

Species:

rat

Strain:

other: CRL (WI) BR of Wistar origin

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
Hygienic level: SPF at arrival and kept in good conventional environment during the study.
Age of animals: Young adult rats, 8-12 weeks old
Body weight range at treatment: Male: 307-363 g Female: 192-206 g
Number of animals: 5 male and 5 female (nulliparous and non pregnant animals) rats
Number of animals/group: 5 animals/ sex
Acclimatisation time: 21 days
Acclimatisation to the
test apparatus: 20 days

Environmental conditions
Illumination: Artificial light, from 6 a.m. to 6 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 8-12 air exchanges/hour by central air-condition system.
Environmental conditions were maintained by an air-condition system. Temperature and relative humidity were verified and recorded daily during the study.

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

not specified

Details on inhalation exposure:

A group of ten animals (five males and five females) was exposed to an atmosphere of the test item for a single, continuous four-hour period, generated according to the system and flow rates determined during the technical trials. The four-hour exposure period did not start until theoretical chamber concentration equilibration had been reached. Twice during treatment the aerosol generator was re-filled and the exposure system was cleaned from deposited dust of the test item. These periods were not taken into account in calculation of the average test item concentration and the duration of exposure was expanded accordingly by 54 minutes.
The actual concentration was monitored by the Aerosol Light Scattering Photometer that is part of the exposure system. The test item input rate was adjusted according to the actual readings.

The characteristics of the test atmosphere were as follows:
Mean Mass Median Aerodynamic Diameter (MMAD) (μm): 3.57
Geometric Standard Deviation: 2.93
Inhalable Fraction (% < 4μm): 54.3

Analytical verification of test atmosphere concentrations:

yes

Remarks:

The actual test item concentration was measured gravimetrically at regular intervals during exposure by pulling a volume of 5 L of test atmosphere from the exposure chamber through glass fibre filters Fiberfilm T60A20 (Pallflex Product Corp.).

Duration of exposure:

4 h

Remarks on duration:

followed by a fourteen day observation period

Concentrations:

Mean Achieved Concentration (mg/L): 5.221
Relative Standard Deviation (%): 12.0
Nominal Concentration (mg/L): 24.3

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:twice daily for morbidity and/or mortality, all animals were observed for clinical signs at 1st, 2nd and 3rd hours during exposure, as soon as practicable following removal from restraint, one hour after exposure and subsequently once daily for fourteen days.
Body Weight: Individual bodyweights were recorded on the day of exposure Day 0 (prior to exposure) and Days 1, 3, 7 and 14.
- Necropsy of survivors performed: yes, at the end of the fourteen day observation period, the animals were euthanized by exsanguination under anaesthesia (intra-peritoneal injection of Euthasol® 40%) and gross necropsies were performed. These included a detailed examination of the abdominal and thoracic cavities with special attention given to the respiratory tract for macroscopic signs of irritancy or local toxicity.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: see above

Statistics:

Dose group: 5 mg/L: No animal died during the study.

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.221 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

In the male and female animals no test item related effects during the inhalation exposure and observation period were found.

Body weight:

In both genders body weight loss was observable on the day of inhalation exposure. In both sexes a compensation of body weight loss was found from third day of observation period.
On basis of body weight and body weight gain data, there was no notable test item effect observable in the exposed animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions of this study, no deaths occurred in a group of ten rats exposed to a mean atmospheric concentration of 5.221 mg/L for four hours. The acute inhalation median lethal concentration (4h LC50) of test item Silic acid Aluminium Magnesium Sodium salt, in Wistar Crl:(WI) BR rats, was therefore considered to be higher than 5.221 mg/L.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 221 mg/m³ air

Quality of whole database:

RL1

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-10-04 - 2016-11-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Qualifier:

according to guideline

Guideline:

OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Remarks:

Rheinland-Pfalz Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

Test Item Silicic acid Aluminium Magnesium Sodium Salt
Lot Number code # 1107274003
Purity > 99 %
CAS No 12040-43-6
Appearance White powder
Composition Silicic acid Aluminium Magnesium Sodium Salt
Homogeneity Homogeneous
Production Date 2011
Expiry Date 01.11.2018
Storage Room Temperature: (20 ± 5°C), dry
Test Item Receipt According to SPPA-00147-BIO, Test and Reference Items

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species Wistar rats
Source Dobrá Voda, Slovak Republic
Number and Sex of Animals 5 males and 5 females
Age at First Dose 8-12 weeks; female animals were non-pregnant and nulliparous
Animal Health The health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation The animals were acclimated to the condition identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition The animals were housed in plastic cages suspended on stainless steel racks, up to 2-3 animals per cage, males and females separately in a room equipped with central air-conditioning. The average room temperature was maintained within the range of 22.1 ± 0.3° C, relative humidity within 56.2 ± 2.7 %. The light regimen was set to a 12-hour light /12-hour dark cycle. The sanitation was performed according to the standard operation procedures.
Diet A laboratory food ssniff (ssniff Spezialdiäten GmbH) was offered in recommended doses each day approximately at the same time. The certificate of analysis is included in the raw data.
Water The animals received tap water for human consumption. Supply of drinking water was unlimited. The quality of drinking water is periodical analysed (including microbiological control) and recorded; certificate of analysis is included in raw data.
Bedding Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification Each animal was marked with an ID number. Each cage was affixed with a cage card containing pertinent animal and study information. The animals in cages were marked by a line on the tail with an ink marker.
Justification for the Choice of Species Normally females are used in the test according to OECD TG 402 because mostly females are the more sensitive gender, but there is still a possibility that this assumption will not be confirmed. For this reason, one dose in males was used to verify sensitivity of sexes after assessing acute toxicity in females.

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animals by clipping and shaving. A precise amount of the test item was aspirated into an adjustable pipette and application directly on the shaved skin of back in a single dose uniformly over an area approximately 10 % of the total body surface area. Test item was held in contact with the skin by using semi-occlusive dressing with non-irritating tape throughout the 24-hours exposure period. At the end of the exposure period, any residuals of the test item were removed by using lukewarm water without altering the existing response or integrity of the epidermis.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

A limit dose of 2000 mg/kg body weight was used as starting dose. One female was dosed. Test item-related mortality was not observed during 24 hours. A total of five female rats were dosed with a limit dose of 2000 mg/kg body weight. An additional group of 5 males was tested at the same dose.

Statistics:

All test animals survived the limit dose of 2000 mg/kg body weight

Preliminary study:

A limit dose of 2000 mg/kg body weight was used as starting dose. One female was dosed. Test item-related mortality was not observed during 24 hours. A total of five female rats were dosed with a limit dose of 2000 mg/kg body weight. An additional group of 5 males was tested at the same dose.

Key result

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study. Animals lived through observation period without signs of intoxication.

Clinical signs:

other: Neither change of health nor negative reactions were registered.

Gross pathology:

All animals (5 females and 5 males) were necropsied. During necropsy, no macroscopic changes were noticed.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Silicic acid Aluminium Magnesium Sodium Salt according to the Globally Harmonised System and Category Labelling of Chemicals can be classified in Category 5/Unclassified with LD50 value greater than 2000 mg/kg body weight after single dermal application to Wistar rats.

Executive summary:

The test item Silicic acid Aluminium Magnesium Sodium Salt applied to 5 females and 5 males at a limit dose of 2000 mg/kg body weight did not cause death. All females and males survived the limit dose of 2000 mg/kg body weight. No body weight losses were observed between one and two weeks after application of the test item. No signs of toxicity were observed at the dosage of 2000 mg/kg body weight during the first 4 hours in females or 14-day observation period. No dermal changes were observed. During necropsy no macroscopic findings were noticed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

RL1

Additional information

Oral

The acute oral toxicity of silicic acid, aluminium magnesium sodium salt was tested according to the OECD guideline 423 (Colas 2009). The test substance was administered to female rats at a dose of 2000 mg/kg bw. During the observation period of 14 days, no signs of toxicity or mortality were recorded. In accordance with the OECD guideline 423, the LD50 cut-off of the test item may be considered higher than 5000 mg/kg bw for the oral route in the rat.

 

Inhalation

The inhalative acute toxicity of silicic acid, aluminium magnesium sodium salt was tested according to the OECD guideline 403 (Stahl 2012). The test substance was administered to male and female rats at a dose of 5.221mg/L (aerosol). During the observation period of 14 days, no signs of toxicity or mortality were recorded. In accordance with the OECD guideline 403, the LC50 of the test item is higher than 5.221 mg/l aerosol concentration by inhalation route in the rat.

 

Dermal

Silicic acid Aluminium Magnesium Sodium Salt according to the Globally Harmonised System and Category Labelling of Chemicals can be classified in Category 5/Unclassified with LD50 value greater than 2000 mg/kg body weight after single dermal application to Wistar rats. As no significant effects or signs were observed or indications from other studies are known, test item is not classified according to GHS nor to CLP EUregulation.

Justification for selection of acute toxicity – oral endpoint

test item same as reference substance

Justification for selection of acute toxicity – inhalation endpoint

test item same as reference substance

Justification for selection of acute toxicity – dermal endpoint

test item same as reference substance

Justification for classification or non-classification

Oral and Inhalation

In accordance with the Globally Harmonised System (Regulation (EC) No 1272/2008), the test item does not need to be classified. No signal word and hazard statement are required.

 

Dermal

Silicic acid Aluminium Magnesium Sodium Salt according to the Globally Harmonised System and Category Labelling of Chemicals can be classified in Category 5/Unclassified with LD50 value greater than 2000 mg/kg body weight after single dermal application to Wistar rats.