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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
Formaldehyde, polymer with 2-(chloromethyl)oxirane and phenol
IUPAC Name:
Formaldehyde, polymer with 2-(chloromethyl)oxirane and phenol
Constituent 3
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.

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.