Registration Dossier
Registration Dossier
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EC number: 701-263-0 | CAS number: -
Genetic toxicity: in vivo
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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Reaction mass of 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]dioxirane and [2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane and [2,2'-[methylenebis(2,1-phenyleneoxymethylene)]dioxirane
- EC Number:
- 701-263-0
- Cas Number:
- 9003-36-5
- Molecular formula:
- C6 H6. C3 H5 Cl . C H2 O)x
- IUPAC Name:
- Reaction mass of 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]dioxirane and [2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane and [2,2'-[methylenebis(2,1-phenyleneoxymethylene)]dioxirane
- Reference substance name:
- Formaldehyde, polymer with 2-(chloromethyl)oxirane and phenol
- IUPAC Name:
- Formaldehyde, polymer with 2-(chloromethyl)oxirane and phenol
- Reference substance name:
- Bisphenol F Diglycidylether (BPFDGE)
- IUPAC Name:
- Bisphenol F Diglycidylether (BPFDGE)
- Details on test material:
- As per IUCLID5 Sections 1.1 - 1.4.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system 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.
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