Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A scientific review by authorative international body

Data source

Reference
Reference Type:
review article or handbook
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 silica.
GLP compliance:
no
Remarks:
review - both yes and no status
Test type:
other: different acute oral toxicity tests

Test material

Constituent 1
Reference substance name:
112926-00-8; 112945-52-5
IUPAC Name:
112926-00-8; 112945-52-5
Details on test material:
Tradenames studied in OECD (2004): Aerosil 200; Sident 9; Sipernat 22; Syloid 244; Tixosil 53; Aerosil 130, 150, 200, 300, OX50, Ultrasil VN 2 and 3, silika FK types, Sident 3, Sipernat AS 7, 22, 30 and 42; ZEO 49, ZEOSYL 113, ZEOSYL 200, ZEOFREE 153; Positive Sol 130M; Cab-O-Sil M-5 and F-2

Test animals

Species:
other: rat and mouse

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Remarks on result:
other: hydrophilic precipitated silica
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: hydrophilic precipitated silica
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Remarks on result:
other: several silica types
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 20 000 mg/kg bw
Remarks on result:
other: hydrophilic precipitated silica
Sex:
male
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Remarks on result:
other: hydrophilic pyrogenic silica

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
OECD (2004) includes 12 acute oral toxicity studies with synthetic amorphous silica, of which five is regarded as critical study for SIDS endpoint. These five studies are conducted with hydrophilic precipitated or pyrogenic silica. In the critical studies, the LD50 or LDO value was at least >3160 mg/kg bw, thus showing no acute oral toxicity.
Executive summary:

In OECD (2004), the acute oral administration of hydrophilic precipitated or pyrogenic silica either by gavage or in the diet

failed to produce signs of toxicity or deaths in treated animals with LD50values greater than the top doses applied. Thus, the LD50values varied from >3100 to >20000 mg/kg bw. In conclusion, acute oral ingestion to high doses of synthetic amorphous silica will produce no systemic toxicity.