Reaction mass of 1,1,1,5,5,5-hexamethyl-3-phenyl-3-((trimethylsilyl)oxy)trisiloxane and 1,1,1,7,7,7-hexamethyl-3,5-diphenyl-3,5-bis[(trimethylsilyl)oxy]tetrasiloxane and 1,1,1,9,9,9-hexamethyl-3,5,7-triphenyl-3,5,7-tris((trimethylsilyl)oxy)pentasiloxane

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:

no data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The study did not meet current guideline requirements for reproductive toxicity. It does, however, add weight of evidence for reproductive toxicity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Repeated oral dose 4-week study to assess effects on male reproductive system.

GLP compliance:

no

Remarks:

study precedes GLP

Type of method:

in vivo

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

4 weeks

Frequency of treatment:

daily (5 days/week)

Duration of test:

4 weeks

Doses / concentrations

Dose / conc.:

1 other: ml/kg bw/day (actual ingested)

No. of animals per sex per dose:

10

Control animals:

other: tap water... (see attached file)

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

>= 1 other: ml/kg bw/day

Based on:

test mat.

Sex:

male

Basis for effect level:

other: no significant adverse effects on the male reproductive system observed at this dose

Observed effects

Treatment with Dow Corning(R) 556 Cosmetic Grade Fluid had no significant effect on the absolute or relative weights of the testes, epididymis or prostate. An apparent dilation of the vessels supplying the testes was seen in one treated rat. No general systemic toxicity was observed.

Applicant's summary and conclusion

Conclusions:

In a non-guideline study conducted prior to the introduction of GLP, no adverse effects were observed on the reproductive systems of ten male rats administered Dow CorningR 556 Cosmetic Grade Fluid orally at 1 ml/kg bw/day for 4 weeks. In this limited study, the no-observed-adverse-effect level (NOAEL) was 1 ml/kg bw/day (the only dose tested).

Executive summary:

In a non-guideline study, conducted prior to the introduction of GLP, the potential for oral exposure to Dow Corning^R556 Cosmetic Grade Fluid to affect the reproductive systems of male rats was investigated.

 

Ten male Sprague-Dawley rats were given daily doses of the test material at 1 ml/kg bw via oral gavage five days a week, for four weeks. A further two groups of ten rats acted as controls, and were given either A&D Ointment (without hexachlorophene) or tap water. Animals were necropsied and gross abnormalities were recorded. The weights of all testes, epididymides and prostates were recorded.

 

In one rat, an apparent dilation of the vessels supplying the testes was observed. Besides this, there were no gross abnormalities detected in treated rats. There were no treatment-related effects on the absolute or relative weights of the reproductive organs. In this limited study, the no-observed-adverse-effect level (NOAEL) was 1 ml/kg bw/day (the only dose tested).