Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
29-Feb-1984 to 01-Mar-1984
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only a summary report was available for review.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Evaluation for cytopathic effect by placing the test material, octamethyltrisiloxane, in direct contact for 24 hours with a confluent monolayer of human embryonic cells in vitro.
GLP compliance:
yes
Remarks:
FDA GLP Regulations
Type of method:
in vitro
Endpoint addressed:
other: tissue cell biocompatibility

Test material

Constituent 1
Chemical structure
Reference substance name:
Octamethyltrisiloxane
EC Number:
203-497-4
EC Name:
Octamethyltrisiloxane
Cas Number:
107-51-7
Molecular formula:
C8H24O2Si3
IUPAC Name:
2,2,4,4,6,6-hexamethyl-3,5-dioxa-2,4,6-trisilaheptane

Test animals

Species:
human
Strain:
other: Flow 7000 human embryonic foreskin cells
Sex:
male

Administration / exposure

Route of administration:
other: in vitro
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
24 hours
Frequency of treatment:
once
Post exposure period:
not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
no data
Basis:
no data
No. of animals per sex per dose:
not applicable
Control animals:
yes
other: positive control (unspecified)

Results and discussion

Details on results:
No cytopathic effect was observed after treatment with the test material [no details available].

Applicant's summary and conclusion

Conclusions:
Octamethyltrisiloxane was evaluated for its cytopathic effect in human embryonic cells. After 24 hours in direct contact, no cyotpathic effect was observed.
Executive summary:

Octamethyltrisiloxane (Dow Corning 200 Fluid, 1 CS) was tested for cytopathic effects in vitro in a non-guideline study conducted to GLP. It was applied in direct contact with a monolayer of cultured human embryonic cells and the cultures incubated at 37 °C for 24 hours. On microscopic examination there was no evidence of cytopathic effect in comparison with positive and negative controls.