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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: 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: see 'Remark'
Remarks:
A scientific review by authorative international body. Read-across to synthetic amorphous silica: The amorphous glass phase of FeCr-slag consists of practically insoluble silicates, and therefore selection of synthetic amorphous silica for read-across is justified.

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 synthetic amorphous silca. For acute dermal toxicity, only one acceptable study was available, in which rabbits were treated dermally with up to 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: evaluation by authoritative body

Test material

Constituent 1
Reference substance name:
synthetic amorphous silica
IUPAC Name:
synthetic amorphous silica
Constituent 2
Reference substance name:
112926-00-8
EC Number:
601-214-2
Cas Number:
112926-00-8
IUPAC Name:
112926-00-8

Test animals

Species:
rabbit

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: Silica, precipitated, cryst.-free

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The OECD (2004) evaluation on synthetic amorphous silica includes two acute dermal toxicity studies, of which one is a critical study for SIDS endpoint. This study with synthetic amorphous silica did not show acute dermal toxicity.
Executive summary:

OECD (2004) evaluated one acceptable study on acute dermal toxicity of synthetic amorphous silca. After dermal application of up to 5000 mg/kg bw of aqueous pastes of precipitated synthetic amorphous silica to the intact and abraded skin of rabbits for 24 hours under occlusive conditions, no signs of systemic or organ toxicity were noted. There were only very slight transient erythemas at the site of treatment in solitary animals. OECD concluded that the dermal exposure to high doses of synthetic amorphous silica will produce no systemic toxicity.