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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

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Administrative data

Endpoint:
eye irritation
Remarks:
other: OECD evaluation of unpublished in vivo studies
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 For eye irritation, three unpublished studies were evaluated. OECD ranked the reliability of the study as 2: Meets national standards with acceptable restrictions, and 2: Meets generally accepted scientific standards, sufficiently documented, acceptable for assessment.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Sodium aluminium silicate
IUPAC Name:
Sodium aluminium silicate

Test animals / tissue source

Species:
rabbit

Results and discussion

In vivo

Results
Irritation parameter:
other: erythema and oedema
Time point:
other: 24 h
Score:
>= 0 - <= 2
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Results of three different studies reviewed by OECD
Irritant / corrosive response data:
Not irritating. No effects, or only weak and transient effects on the conjunctivae were observed.

Any other information on results incl. tables

No effects, or only weak and transient oedema and/or erythema were observed after 24 h, but the symptoms had subsided after 48 h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
In the OECD SIDS it was concluded that Na-Al-silicate is not irritating to eyes under experimental conditions.
Executive summary:

OECD (2004) evaluated the available test data on Na-Al-silicate. For eye irritation, three unpublished studies were evaluated. In the OECD SIDS it was concluded that Na-Al-silicate is not irritating to eyes under experimental conditions. No effects, or only weak and transient effects on the conjunctivae were observed.