Silicic acid, calcium salt

Toxicity to reproduction

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

Test material information

Constituent 1

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.