4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane

Toxicity to reproduction: other studies

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Four-Day Uterine Weight Assay, Screening Methods in Pharmacology

Test guideline 2

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

Test material information

Constituent 1

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 / concentrations

Doses / concentrations 1

Dose / conc.:

50 other: ml/kg bw

Remarks:

Basis:
nominal conc.
test substance (oral)

Doses / concentrations 2

Dose / conc.:

0.001 other: µg / kg bw estradiol

Remarks:

Basis:
nominal conc.
estradiol as positive control (i.m.)

Doses / concentrations 3

Dose / conc.:

50 other: ml/kg bw

Remarks:

Basis:
nominal conc.
peanut oil as negative control (oral)

Doses / concentrations 4

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

1

Dose descriptor:

other: uteri weights

Effect level:

> 50 other: ml /kg bw (nominal)

Based on:

test mat.

Sex:

female

2

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.