Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
CHEMOTHERAPEUTIC ACTIVITY of 5-FLUOROCYTOSINE
Author:
E. GRUNBERG, E. TITSWORTH, and M. BENNETT
Year:
1963
Bibliographic source:
Chemotherapeutic activity of 5-fluorocytosine.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute toxicities were determined by administration of single doses of 5-fluorocytosine to adult Swiss albino mice by the intravenous, intraperitoneal, subcutaneous, and oral routes.
The LD50 values were calculated according to the method of Reed and Muench (1938).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Flucytosine
EC Number:
217-968-7
EC Name:
Flucytosine
Cas Number:
2022-85-7
Molecular formula:
C4H4FN3O
IUPAC Name:
flucytosine
Test material form:
not specified

Test animals

Species:
mouse
Strain:
Swiss
Sex:
not specified

Administration / exposure

Route of administration:
other: intravenous, intraperitoneal and subcutaneous
Vehicle:
not specified
Doses:
not specified
No. of animals per sex per dose:
not specified
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
not specified
Dose descriptor:
LD50
Remarks:
intravenous
Effect level:
500 mg/kg bw
Based on:
test mat.
Key result
Sex:
not specified
Dose descriptor:
LD50
Remarks:
subcutaneous
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
not specified
Dose descriptor:
LD50
Remarks:
intraperitoneal
Effect level:
1 190 mg/kg bw
Based on:
test mat.
Mortality:
not reported
Clinical signs:
not reported
Body weight:
not reported

Applicant's summary and conclusion

Conclusions:
In the present study conducted prior to implementation of GLP and OECD guidelines the test susbtance was administered to Swiss mice, subcutaneously, intravenously and intraperitoneally at up to 2000 mg/kg bw. The LD50 values were calculated according to the method of Reed and Muench (1938). Hence, the LD50 (intravenous) was determined to be 500 mg/kg bw, the LD50 (intraperitoneal) was 1190 mg/kg bw and the LD50 for the subcutaneous application was > 2000 mg/kg bw. Due to methodological deficiencies the study cannot be used for classification and labeling according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).