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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)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Four-Day Uterine Weight Assay, Screening Methods in Pharmacology
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD 440: Uterotrophic bioassay in rodents, a short-term screening test for oestrogenic properties
Version / remarks:
2017
Deviations:
yes
Remarks:
Only one treatment group, limited information on the experimental conditions
Principles of method if other than guideline:
Based on the effect of estrogen 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:
For the substance, C18H42O6SnSi2 (n = 2 – 4) Constituent 1 (S2): C18H42O6S2Si2 Constituent 2 (S3): C18H42O6S3Si2 Constituent 3 (S4): C18H42O6S4Si2
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 estradiol (as estradiolbezoate) 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
Dose / conc.:
50 other: ml/kg bw
Remarks:
Basis:
nominal conc.
test substance (oral)
Dose / conc.:
0.001 other: µg / kg bw estradiol
Remarks:
Basis:
nominal conc.
estradiol as positive control (i.m.)
Dose / conc.:
50 other: ml/kg bw
Remarks:
Basis:
nominal conc.
peanut oil as negative control (oral)
Dose / conc.:
10 other: ml/kg bw
Remarks:
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, estradiol
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 this four-day uterine weight assay, no increase in uterine weight was determined with the test item compared to the control group.