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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to a testing guideline or the GLP regulations. Furthermore, there was limited study detail upon witch to access the validity of the study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no
Type of assay:
chromosome aberration assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1 - 1.4.

Test animals

Species:
hamster, Chinese
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Chinese hamsters weighing 22 - 31 grams were used for the study. They were maintained on a diet of NAFAG No. 924 and provided water ad libitum. The animal room had a temperature of 21 C +/- 1 C and a humidity of 70 - 80%. Illumination was 12 hr/day.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Polyethylene glycol
Details on exposure:
Oral gavage
Duration of treatment / exposure:
2 days
Frequency of treatment:
Twice
Post exposure period:
none
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 1000, 2000, and 4000 mg/kg of body weight.
Basis:
nominal conc.
No. of animals per sex per dose:
8
Control animals:
yes, concurrent vehicle
Positive control(s):
Cyclophosphamide 64 mg/kg

Examinations

Tissues and cell types examined:
bone marrow
Details of tissue and slide preparation:
the bone marrow cells wee harvested by centrifugation and the resulting cell pellets fixed in methanol/acetic acid 3:1 for 30 min at room temperature. The pellets were resuspended in fixative and centrifuged at 150 g for 5 minutes. The pellets were resuspended in fixative and stored overnight at 4 C. The pellets were resuspended again, centrifuged and the pellet resuspended in approximately 0.5 mL fixative. This final suspension was pipetted onto wet slides and stained with acetic-orcein.
Evaluation criteria:
No data
Statistics:
No data

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Treatment of chinese hamsters with the positive control cyclophosamide resulted a substantial increase in the number of bone marrow cells observed with chromosomal aberrations of approximately 24%. There was no increase of the chromosomal aberration frequency in bone marrow cells from the Chinese hamsters treated with Bisphenol F Diglycidylether (BPFDGE) up to the high dose level of 4000 mg/kg.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Oral gavage treatment of Chinese hamsters with Bisphenol F Diglycidylether up to a high dose of 4000 mg/kg did not cause an increase of structural chromosome damage in bone marrow cells. Therefore, BPFDGE is not genotoxic under the conditions of this in vivo assay.
Executive summary:

Bisphenol F Diglycidylether (BPFDGE) was accessed for the potential to induce chromosomal aberrations in the bone marrow cells of Chinese hamsters treated by oral gavage up to a high dose level of 4000 mg/kg. Oral gavage treatment of Chinese hamsters with Bisphenol F Diglycidylether up to a high dose of 4000 mg/kg did not cause an increase of structural chromosome damage in bone marrow cells. Therefore, BPFDGE is not genotoxic under the conditions of this in vivo assay.