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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Carcinogenicity

Currently viewing:

Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
GLP compliance:
not specified
Remarks:
Not specified in OECD (2016)

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicon dioxide
EC Number:
231-545-4
EC Name:
Silicon dioxide
Cas Number:
7631-86-9
Molecular formula:
O2Si
IUPAC Name:
Silicon dioxide
Test material form:
solid
Specific details on test material used for the study:
Syloid 244

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Duration of treatment / exposure:
93 weeks continuous exposure with interim kill after 6 and 12 months.
Doses / concentrationsopen allclose all
Dose / conc.:
1.25 other: % nominal concentration
Dose / conc.:
2.5 other: % nominal concentration
Dose / conc.:
5 other: % nominal concentration
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
ca. 5 000 - ca. 7 000 mg/kg bw/day (actual dose received)
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: Cancerogenicity

Target system / organ toxicity

Key result
Critical effects observed:
no
System:
other: L5178YTK mouse lymphocytes
Organ:
other: L5178YTK mouse lymphocytes

Applicant's summary and conclusion

Conclusions:
Synthetic silicon dioxide was not found to be cancerogenic in vitro using mammalian cells.
Executive summary:

Mice of both genders were contionously exposed to synthetic silicon dioxide for 93 weeks via oral feed.

NOAEL (highest dose level tested: 5 % in the diet) was approximately 5000 — approximately 7000 mg/kg bw/day (actual dose received. Synthethic silicon dioxide was not found to be cancerogenic.