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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose 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. Read-across to other 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 For repeated dose toxicity via the oral route, two unpublished subacute studies were evaluated. OECD ranked the reliability of the study as 2: Meets generally accepted scientific standards, sufficiently documented, acceptable for assessment.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Sodium aluminosilicate
IUPAC Name:
Sodium aluminosilicate

Test animals

Species:
other: OECD evaluation of available rat and mouse studies

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
14 days
Frequency of treatment:
Continuous
Doses / concentrations
Remarks:
Doses / Concentrations:
0.625-10%
Basis:
nominal in diet
No. of animals per sex per dose:
5

Results and discussion

Results of examinations

Body weight and weight changes:
effects observed, treatment-related
Details on results:
The body weight of the male rats in the 10% feeding group was significantly reduced (-39%). No substance-related clinical findings were observed at any dose levels.

Effect levels

Dose descriptor:
NOAEL
Effect level:
ca. 2 500 mg/kg bw/day (nominal)
Basis for effect level:
other: Body weight gain

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No adverse effects could be demonstrated after oral application, except at very high doses. OECD SIDS conclusions: after oral application an overall NOAEL of approximately 2500 mg/kg bw can be established.
Executive summary:

OECD (2004) evaluated the available test data on Na-Al-silicate. For repeated dose toxicity via the oral route, two unpublished subacute studies (14 days feeding studies in rats and mice) were evaluated. No adverse effects could be demonstrated after oral application, except at very high doses, when the body-weight gain in male rats was significantly reduced (-39%). OECD SIDS conclusions: after oral application an overall NOAEL of approximately 2500 mg/kg bw can be established.