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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
carcinogenicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
The Tumor-promoting Action of Phenol and Related Compounds for Mouse Skin.
Author:
Boutwell, R.K.
Year:
1959
Bibliographic source:
Cancer Research 19, 413-423

Materials and methods

Principles of method if other than guideline:
Initiation/promotion assay: The TS was applied repeatedly to the skin of the backs of mice following a single application of dimethylbenzanthracene (DMBA).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Fluorobenzene
EC Number:
207-321-7
EC Name:
Fluorobenzene
Cas Number:
462-06-6
Molecular formula:
C6H5F
IUPAC Name:
fluorobenzene

Test animals

Species:
mouse
Strain:
other: Sutter
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 2-3 months
- Housing: in screen-bottomed metal cages in air-conditioned animal rooms
- Diet: Purina Laboratory Chow ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 3

Administration / exposure

Route of administration:
dermal
Vehicle:
other: redistilled thiophene-free benzene
Details on exposure:
About one week prior to the first application of the TS the fur was shaved from the test area of the back of the mice with electric clippers. Because of the possibility of mechanical irritation and damage to papillomas, the mice were not shaved after the experiment was started. The solutions to be tested were applied as a single drop to the mid-dorsal region of each mouse. Since the droppers delivered a known volume, the amount of solute deposited on the skin could be calculated. In each case, treatment with the promoting agent was begun 1 week after the single application of initiator and was continued twice each week until the experiment was discontinued.
Duration of treatment / exposure:
12 weeks
Frequency of treatment:
twice per week
Doses / concentrations
Dose / conc.:
1 other: drop of a 20% (w/v) solution
Remarks:
approx. 25 µl
No. of animals per sex per dose:
24 females

Examinations

Observations and examinations performed and frequency:
The mice were inspected for tumours weekly. Only typical papillomas larger than about 1 mm in diameter were counted, care being taken to exclude hyperplasias and other miscellaneous lesions. The gross identifications of both benign and malignant tumours were confirmed periodically by microscopic examination.

Results and discussion

Results of examinations

Mortality:
not specified
Description (incidence):
Four animals died during the course of the experiment.

Effect levels

Dose descriptor:
other: Tumour-promoting activity
Based on:
test mat.
Sex:
female
Remarks on result:
not determinable due to absence of adverse toxic effects

Any other information on results incl. tables

The incidence of tumours in mice treated with fluorobenzene (Initiator: 0.3% DMBA in acetone. Promotor: in benzene. Data: at 12 weeks.):

Promotor (applied twice weekly)

No. mice

(survivors/original)

Average papilloma per survivor

Per cent survivors with papilloma

Per cent survivors with carcinoma*

20% fluorobenzene

20/24

0

0

0

* The incidence of carcinomas was calculated on the basis of the number of mice alive in each group on the date chosen for presentation of the data; this is not the usual definition for effectual total.

Applicant's summary and conclusion

Conclusions:
No tumour-promoting activity after a single pre-treatment with the carcinogenic dimethylbenzanthracene (DMBA).