Silicic acid, aluminum magnesium sodium salt

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

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

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum magnesium sodium salt

EC Number:

234-919-5

EC Name:

Silicic acid, aluminum magnesium sodium salt

Cas Number:

12040-43-6

Molecular formula:

Na(0.017-1.739)Mg(0.008-0.823)Al(0.002-0.2473)SiO(2.018-3.837)

IUPAC Name:

aluminium(3+) magnesium(2+) sodium tris(oxosilanebis(olate))

Test material form:

solid: particulate/powder

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

Test animals

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.

Administration / exposure

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

Results and discussion

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.

Effect levels

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.

Applicant's summary and conclusion

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.