Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
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.

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 oral toxicity, only one study was available, in which rats were given 5000 mg/kg of the test substance. OECD ranked the reliability of the study as 2: Meets national standards with acceptable restrictions: short documentation, sufficient for assessment.
GLP compliance:
no
Test type:
other: OECD evaluation of available tests (fixed dose)
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:
rat

Administration / exposure

Route of administration:
oral: gavage
Doses:
5000 mg/kg

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality observed at the test dose.

Any other information on results incl. tables

OECD concluded that the oral acute toxicity test failed to produce signs of toxicity or deaths in treated animals.

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 oral ingestion to high doses of Na-Al-silicate (5000 mg/kg bw) will produce no systemic toxicity. LD50 was >5000 mg/kg bw.
Executive summary:

The OECD SIDS(2004) evaluated the available test data on Na-Al-silicate. For acute oral toxicity, only one study was available, in which rats were given 5000 mg/kg of the test substance. In the OECD SIDS, it was concluded that acute oral ingestion of high doses of Na-Al-silicate (5,000 mg/kg bw) will produce no systemic toxicity. LD50was >5,000 mg/kg bw.