Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
September 1983
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Four-Day Uterine Weight Assay, Screening Methods in Pharmacology
Principles of method if other than guideline:
Based on the effect of oestrogene to increase the protein synthesis and consequently to increase the uterine weights and water retention in the uterine tissue.
GLP compliance:
yes
Type of method:
in vivo

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
EC Number:
915-673-4
Cas Number:
211519-85-6
Molecular formula:
C18H42O6SxSi2
IUPAC Name:
Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Test animals

Species:
mouse
Strain:
NMRI
Sex:
female
Details on test animals or test system and environmental conditions:
animal weights: 10 - 12 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on exposure:
Test substance: 50 ml /kg bw by gavage
Positive control: 0.001 /kg bw oestradiol (as oestradiolbezoate) intramuscular
Negative control: 50 ml / kg bw peanut oil by gavage
Negative control: 10 ml /kg bw peanut oil intramuscular
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
3 days
Frequency of treatment:
3 times, each after 24 h
Duration of test:
4 days
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
50 ml/kg bw
Basis:
nominal conc.
test substance (oral)
Remarks:
Doses / Concentrations:
0.001 µg / kg bw estradiol
Basis:
nominal conc.
oestradiol as positive control (i.m.)
Remarks:
Doses / Concentrations:
50 ml/kg bw
Basis:
nominal conc.
peanut oil as negative control (oral)
Remarks:
Doses / Concentrations:
10 ml/kg bw
Basis:
nominal conc.
peanut oil as negative control (i.m.)
No. of animals per sex per dose:
10 animals
Control animals:
yes, concurrent vehicle
other: positive control
Details on study design:
On day 4 the animals were sacrificed. The wet and dry (dried at 100°C , 24h) weights of uteri were determined
Statistics:
Student's t-test

Results and discussion

Effect levels

open allclose all
Dose descriptor:
other: uteri weights
Effect level:
> 50 other: ml /kg bw (nominal)
Based on:
test mat.
Sex:
female
Dose descriptor:
other: uteri weights
Effect level:
0.001 other: µg/kg bw
Based on:
other: positive control, oestradiol
Sex:
female

Observed effects

No effects in the test material and negative control group.
A statistical significant increase in the uteri wet and dry weights in the positive control.

Applicant's summary and conclusion

Conclusions:
Based on the results of the study with the read-across substance (polysulfides, bis[3-(triethoxysilyl)propyl], 211519-85-6) (LPT 1983) no endocrine effects were determined.