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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD SIDS assessment report; reliable, comprehensive evaluation of all available tests. Read-across to synthetic amorphous silicates.

Data source

Reference
Reference Type:
other: evaluation
Title:
SIDS initial assessment report for SIAM 19. Synthetic amorphous silica and silicates.
Author:
OECD
Year:
2004
Bibliographic source:
UNEP Publications, Berlin.

Materials and methods

Principles of method if other than guideline:
OECD evaluated the available test data on Na-Al-silicate. For acute dermal toxicity, only one study was available, in which rabbits were treated dermally with 2000-5000 mg/kg of the test substance. OECD ranked the reliability of the study as 2: Meets generally accepted scientific standards, sufficiently documented, acceptable for assessment.
GLP compliance:
no
Test type:
other: OECD evaluation of acute dermal tests (four doses)
Limit test:
no

Test material

Constituent 1
Reference substance name:
Silicic acid, aluminium sodium salt
IUPAC Name:
Silicic acid, aluminium sodium salt

Test animals

Species:
rabbit

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
24 h
Doses:
2000-5000 mg/kg bw
Details on study design:
In the study evaluated by OECD acute dermal applications of up to 5000 mg/kg bw of aqueous pastes of precipitated Na-Al-silicate were carried out to the intact and abraded skin of rabbits for 24 h under occlusive conditions.

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No

Any other information on results incl. tables

No signs of systemic or organ toxicity were noted, as reported in OECD SIDS.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
OECD SIDS concluded that acute dermal exposure to high doses of synthetic amorphous silicates will produce no systemic toxicity. LD50 was >5000 mg/kg bw.
Executive summary:

In the study evaluated by OECD (OECD SIDS 2004), acute dermal applications of up to 5,000 mg/kg bw of aqueous pastes of precipitated Na-Al-silicate were carried out on the intact and abraded skin of rabbits for 24 h under occlusive conditions. No signs of systemic or organ toxicity were noted in the tested animals. OECD SIDS concluded that acute dermal exposure to high doses of synthetic amorphous silicates will produce no systemic toxicity. LD50was >5,000 mg/kg bw.