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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Start: 15 Oct. 1962
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Significant methodological deficiences, acceptable as screening

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
Deviations:
yes
Remarks:
no complete one generation study according to current standards: too low number of animals and examinations, one dose only, dose selection unclear (relatively low dose selected).
Principles of method if other than guideline:
Method:
5 instead of 20 females, 1 male per 5 females (mating ratio 1:5 instead of 1:2); mating over 14 d, only 1 male used per treated and control group
GLP compliance:
no

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:
dioxosilane
Details on test material:
Aerosil, not further specified, hydrophilic: CAS-Name: Silica, amorphous, fumed, crystalline free, CAS-No. 112945-52-5

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
Exposure period: 6 months
Premating exposure period (males): 4.5 months
Premating exposure period (females): 4.5 months
Duration of test: 6 months
Frequency of treatment:
daily
Details on study schedule:
Number of generation studies: 1
Doses / concentrations
Remarks:
Doses / Concentrations:
497 mg/(kg bw*d) (m); 509 mg/(kg bw *d)(f)
Basis:

No. of animals per sex per dose:
5 instead of 20 females, 1 male per 5 females
Control animals:
yes

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
497 mg/kg bw/day
Sex:
male/female

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
497 mg/kg bw/day
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Result: negative

Parents: No clinical symptoms; no mortality,no abnormalities in  body-weight gain and feed consumption, no haematological findings.
 
In pups during lactation [total: 45 and 37 (control), resp.], no behavioral or developmental or structural abnormalities.
 

Applicant's summary and conclusion