4,4',4''-(ethan-1,1,1-triyl)triphenol

Genetic toxicity: in vitro

Administrative data

Endpoint:

genetic toxicity in vitro

Remarks:

Type of genotoxicity: other:

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance with relevant guideline; the study was conducted prior to current OECD 473 guidline.

Data source

Reference

Reference Type:

other: reference to body responsible for the test

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Annex V (Cytogenetics)

Principles of method if other than guideline:

The test substance was evaluated for clastogenic activity in Chinese hamster ovary cells in vitro following 2 hour treatments with and 7.5 hour treatments without metabolic (S9) activation.

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

4,4',4''-(ethan-1,1,1-triyl)triphenol

EC Number:

405-800-7

EC Name:

4,4',4''-(ethan-1,1,1-triyl)triphenol

Cas Number:

27955-94-8

Molecular formula:

C20H18O3

IUPAC Name:

4,4',4''-(ethan-1,1,1-triyl)triphenol

Details on test material:

- Purity: Not reported.

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Details on mammalian cell type (if applicable):

Chinese hamster Ovary (CHO) - Type and identity of media: McCoy's 5a culture medium supplemented with 10% fetal calf serum (FCS), 1% L-glutamine and 1% penicillin and streptomycin.
- Properly maintained: Cell line has an average cycle time of 12-14 hours with a modal chromosome number of 21.
- Periodically checked for Mycoplasma contamination: Not reported.
- Periodically checked for karyotype stability: Cellsd recloned to maintain karyotypic stability.
- Periodically "cleansed" against high spontaneous background: Not reported.

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S9

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 7.48-7.50, 11.2-11.3, 15.0, 29.9, and 44.9 µg/mL
Concentration range in the main test (without metabolic activation): 7.47, 15.0, 22.4, and 29.9 µg/ml

Vehicle / solvent:

Dimethylsulfoxide

Controls

Untreated negative controls:

yes

Remarks:

McCoy's 5a

Negative solvent / vehicle controls:

yes

Remarks:

10.0 µl/mL

Positive controls:

yes

Positive control substance:

other: Mitomycin C was used for the nonactivation series and cyclophosphamide was used in the metabolic activation series. Two doses of mitomycin C were used, 0.5 µg/ml and 1.00 ug/ml. Doses of cyclophosphamide used were 25.0 and 50.0 µg/ml (10 hour harvest)

Details on test system and experimental conditions:

Exposure period (with metabolic activation): 2 hours
Exposure period (without metabolic activation): 7 hours
Fixation time: 10 hours

Results and discussion

Test results

Test results 1

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(33 µg/ml)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(33 µg/ml)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(>30 µg/ml)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(>30 µg/ml)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
There were no significant increases in the percentage of cells with chromosome aberrations under any of the test conditions used.

Remarks on result:

other: other: preliminary test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test substance is considered negative for inducing chromosomal aberrations in Chinese hamster ovary cells under metabolic activation and nonactivation conditions.

Executive summary:

The test substance was evaluated for clastogenic (chromosome-damaging) activity in Chinese hamster ovary cells in vitro following 2 hour treatments with and 7.5 hour treatments without metabolic (S9) activation. Two independent trials were conducted. The maximum concentrations tested were 44.9 µg/mL with metabolic activation and 29.9 µg/mL without metabolic activation. For trials with activation, post-treatment harvest times were 10, 20, and 30 hours. For trials without activation, post-treatment harvest time was 10 hours.

 

No significant increase in chromosomally aberrant cells was observed at any of the concentrations analyzed in any of the assays. The test substance is considered negative for inducing chromosomal aberrations under both nonactivation and activation conditions.