Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
multi-generation reproductive toxicity
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline study with survival of offspring and gross morphological changes as the only parameters examined.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Effects of soluble silica on growth, nutrient balance and reproductive performance of albino rats.
Author:
Smith, G. S. et al.
Year:
1973
Bibliographic source:
J. Animal Sc. 36, 271-278
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Principles of method if other than guideline:
The study was not conducted according to any guideline. For details on test procedure see below.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SOURCE: Diamond Alkali Company, Cleveland, Ohio, USA
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: Molar ratio 3.2

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Duration of treatment / exposure:
Exposure period: 12 weeks, between weaning and sexual maturity, each generation F0, F1, F2, F3 & F4
Premating exposure period (males): 12 weeks
Premating exposure period (females): 12 weeks
Duration of test: 2.5 years
Frequency of treatment:
continuous
Doses / concentrations
Remarks:
Doses / Concentrations:
79 and 159 mg sodium silicate/kg body weight/d
Basis:

Control animals:
yes, concurrent no treatment

Examinations

Statistics:
Chi-square Test

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
> 159 mg/kg bw/day (nominal)
Sex:
female
Basis for effect level:
mortality

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Sex:
male/female
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX: 600 and 1200 mg SiO2/l in  drinking water, corresponding to 790 ppm

and 1580 ppm sodium silicate, respectively. This converts to 79 and 159 mg/kg bw/d on the assumption of  a mean body weight

of 200 g and a mean daily water consumption of 20 ml/d.


TOXIC RESPONSE/EFFECTS BY DOSE LEVEL: 
-Parental data and F1: No effects on mortality, the only parameter  studied, were observed in the parental generation at any

dose level. Reduced pup survival was observed in the treatment groups.

- Mortality: No effects on length of life of the rats receiving sodium silicate in drinking water after weaning. Offspring from the

treatment  groups was frequently stillborn or small and weak, with survival limited  to only a few days. Cannibalism was prevalentamong females receiving  sodium silicate, especially among those receiving 1200 ppm.

The results from the 4 consecutive breedings are reported in the  publication as summed data only:

                              0          600       1200 ppm SiO2
-----------------------------------------------------------------
Number of matings         77          77           77
Number of litters             54          51           49
Total offspring born       517        346*        414*
Total offspring weaned  182        83*          44*

% of offspring weaned   35%       24%          11%
Difference, % of controls
   born                       -           67%          80%
   weaned                     -           46%          24%
-----------------------------------------------------------------
* Values differ from controls, P<0.001

- Offspring toxicity F1: 
- Litter size and weights: On average 9.6, 6.8 and 8.4 animals/litter (at 0, 600 and 1200 mg SiO2/l). No data on body weights
- Viability index: see table above
- Post natal survival until weaning: 35%, 24% and 11% (at 0, 600 and 1200 mg SiO2/l)
- Effects on offspring: Necrosis of the tail and of the feet as well in both treated groups. Litters were frequently stillborn or small and weak.

Applicant's summary and conclusion