Silicic acid, aluminum calcium sodium salt

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study was conducted using a test method similar to OECD Testing Guideline 402, with one amendment. Limited documentation is available, the study is considered acceptable for assessment. Read-across from the results on the test substance has been made to the registered substance based on the similar structure of the two substances.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

24 hour exposure, abraded and intact skin

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminum sodium salt

EC Number:

215-684-8

EC Name:

Silicic acid, aluminum sodium salt

Cas Number:

1344-00-9

Test material form:

not specified

Details on test material:

ZEOLEX 23A - surface area (BET): 65 -80 m2/g, pH 9.8 - 10.6

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

The test substance was applied as paste to the intact and abraded skin of 2 animals of each dose group
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: impervious bandage
- The test substance was applied as paste to the intact and abraded skin of 2 animals each of the dose group

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- For solids, paste formed: yes, aqueous

VEHICLE
- Amount(s) applied (volume or weight with unit): no data

Duration of exposure:

24 h

Doses:

2000, 3000, 4000, and 5000 mg/kg as aqueous paste

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels

Effect levels 1

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Mortality:

none: 0/16 (0/4 per each dose group)

Clinical signs:

other: no data

Gross pathology:

No pathological findings

Other findings:

Dermal reactions were limited to slight erythema and edema.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance was found to be >5000 mg/kg bw. The substance is not classified as an acute dermal toxin according to EU CLP criteria.

Executive summary:

The acute dermal toxicity of the test substance was determined via use of a guideline similar to the OECD Guideline for Testing of Chemicals 402, with the ammendment from OECD 402 being 24 hour exposure to abraded and intact skin. The test involved occlusive application of between 2000 and 5000 mg/kg bw of the test substance to the abraded and intact skin of rabbits. No mortality was recorded and the LD50 was reported as >5000 mg/kg bw. The substance is not classified as an acute dermal toxin accoring to EU CLP criteria. The structure of both silicic acid, aluminium, sodium salt and silicic acid, aluminium, calcium, sodium salt are macromolecular skeletons of silicon and oxygen with the metal cations binding ionically to negatively charged oxygens in the structure. In the silicic acid, aluminium, calcium, sodium salt the metal cations bind ionically to negatively charged oxygens in the structure. The inclusion of calcium salts to the structure of silicic acid, aluminium, sodium salt would not be expected to change the toxicity of the substance.