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EC number: 217-968-7 | CAS number: 2022-85-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-05-24 to 2004-06-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- 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:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- his-/uvrB- for S. typhimurium and trp-/uvrA- for E. coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Experiment 1:
Salmonella strains: 0.05, 0.15, 0.5, 1.5, 5, 15, 50 µg/plate
E. coli strain: 15, 50, 150, 500, 1500, 5000 µg/plate
Experiment 2:
Salmonella strains: 0.05, 0.15, 0.5, 1.5, 5, 15 µg/plate
E. coli strain: 15, 50, 150, 500, 1500, 5000 µg/plate
Amendment was performed based on the results from Experiment 1.
Highest concentration was determined in a preliminary experiment - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solvent formed the best dosable suspension
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene, with metabolic acitvation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48h
NUMBER OF REPLICATIONS: 3 - Rationale for test conditions:
- Test conditions meet the requirements of the OECD test guidelines
- Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met:
The test material should have induced a reproducible, dose-related and statistically (Dunnet´s method ef linear regression) significant increase in the revertant count in at least one strain of bacteria.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 98, TA100, TA1535; TA1537 and E.coli WP2uvrA-
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test material formed a suspension in distilled water, dimethyl-sulphoxide and acetone and was insoluble in dimethyl formamide, ethanol and acetonitrile at 50 mg/mL and tetrahydrofuran at 200 mg/mL.
- Precipitation: non reported
RANGE-FINDING/SCREENING STUDIES: A preliminary test was conducted in TA100 and WP2uvrA- with the following concentrations, 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: detection of the reduction of the backgraund lawn or reduction in number of revertants
Any other information on results incl. tables
Table 1: Number of revertants per plate (mean of 3 plates) experiment I
|
[TA98] |
[TA100] |
[WP2uvrA-] |
[TA1535] |
[TA1537] |
|||||||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
|
0* |
19 ± 2.5 |
32 ± 4.9 |
no |
100 ± 10.8 |
105 ± 16.5 |
no |
20 ± 2.1 |
20 ± 2.5 |
no |
29 ± 1.2 |
16 ±0.0 |
no |
9 ± 2.6 |
19 ± 2.6 |
no |
|
0.05 |
16 ± 6.4 |
27 ± 9.5 |
no |
111 ± 3.2 |
94 ± 17.8 |
no |
NT |
NT |
|
35 ± 6.9 |
12 ± 1.0 |
no |
11 ± 1.5 |
20 ± 3.2 |
no |
|
0.15 |
11 ± 3.2 |
30 ± 4.4 |
no |
91 ± 11.5 |
113 ± 40.4 |
no |
NT |
NT |
|
27 ± 3.8 |
8 ± 0.6 |
no |
9 ± 6.4 |
19 ± 4.6 |
no |
|
0.5 |
8 ± 2.9 |
31 ± 3.8 |
no |
81 ± 12.4 |
113 ± 41.9 |
no |
NT |
NT |
|
34 ± 6.1 |
13 ± 4.7 |
no |
5 ± 2.3 |
12 ± 4.0 |
no |
|
1.5 |
8 ± 2.5 |
21 ± 3.5 |
no |
77 ± 4.5 |
57 ± 6.7 |
yes |
NT |
NT |
|
28 ± 6.7 |
9 ± 1.2 |
yes |
2 ± 1.5 |
13 ± 7.0 |
no |
|
5 |
5 ± 0.0 |
4 |
yes |
6 ± 3.2 |
0 ± 0.0 |
yes |
NT |
NT |
|
14 ± 7.9 |
0 ± 0.0 |
yes |
0 ± 0.0 |
0 ± 0.0 |
yes |
|
15 |
0 ± 0.0 |
0 ± 0.0 |
yes |
0 ± 0.0 |
0 ± 0.0 |
yes |
11 ± 2.0 |
13 ± 3.8 |
|
0 ± 0.0 |
0 ± 0.0 |
yes |
0 ± 0.0 |
0 ± 0.0 |
yes |
|
50 |
0 ± 0.0 |
0 ± 0.0 |
yes |
0 ± 0.0 |
0 ± 0.0 |
yes |
6 ± 5.0 |
9 ± 1.7 |
no |
0 ± 0.0 |
0 ± 0.0 |
yes |
0 ± 0.0 |
0 ± 0.0 |
yes |
|
150 |
NT |
NT |
|
NT |
NT |
|
8 ± 1.5 |
4 ± 1.2 |
no |
NT |
NT |
|
NT |
NT |
|
|
500 |
NT |
NT |
|
NT |
NT |
|
3 ± 1.5 |
9 ± 2.0 |
no |
NT |
NT |
|
NT |
NT |
|
|
1500 |
NT |
NT |
|
NT |
NT |
|
0 ± 0.6 |
4 ± 2.9 |
yes |
NT |
NT |
|
NT |
NT |
|
|
5000 |
NT |
NT |
|
NT |
NT |
|
0 ± 0.0 |
0 ± 0.6 |
yes |
NT |
NT |
|
NT |
NT |
|
|
Positive control |
116 ± 17.3 |
281 ± 22.7 |
|
725 ± 55.6 |
1232 ± 41.2 |
|
1149 ± 59.5 |
163 ± 58.8 |
|
349 ± 40.0 |
244 ± 25.5
|
|
1082 ± 15.7 |
315 ± 40.5 |
|
|
*solvent control with DMSO
NT = not tested at this dose level
Table 2: Number of revertants per plate (mean of 3 plates) experiment II
|
[TA98] |
[TA100] |
[WP2uvrA-] |
[TA1535] |
[TA1537] |
|||||||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
|
0* |
18 ± |
44 ± 10.0 |
no |
88 ± 4.0 |
95 ± 10.2 |
no |
16 ± 2.6 |
40 ± 3.1 |
no |
20 ± 7.6 |
33 ± 4.6 |
no |
12 ± 2.3 |
17 ± 2.1 |
no |
|
0.05 |
20 ± |
29 ± 1.5 |
no |
83 ± 10.3 |
91 ± 11.1 |
no |
NT |
NT |
|
21 ± 3.6 |
32 ± 8.1 |
no |
7 ± 2.1 |
10 ± 2.6 |
no |
|
0.15 |
19 ± |
23 ± 6.1 |
no |
81 ± 9.5 |
94 ± 4.2 |
no |
NT |
NT |
|
17 ± 1.7 |
14 ± 5.2 |
no |
15 ± 4.0 |
15 ± 2.5 |
no |
|
0.5 |
13 ± |
19 ± 1.5 |
no |
71 ± 5.5 |
90 ± 7.2 |
no |
NT |
NT |
|
17 ± 6.6 |
12 ± 4.6 |
no |
9 ± 2.1 |
10 ± 3.1 |
no |
|
1.5 |
21 ± |
17 ± 7.8 |
no |
66 ± 8.5 |
89 ± 2.6 |
yes |
NT |
NT |
|
18 ± 3.0 |
10 ± 2.5 |
no |
7 ± 3.2 |
13 ± 3.0 |
no |
|
5 |
14 ± |
12 ± 1.7 |
no |
35 ± 3.1 |
52 ± 12.6 |
yes |
NT |
NT |
|
3 ± 1.7 |
4 ± 1.2 |
yes |
0 ± 0.0 |
1 ± 0.6 |
yes |
|
15 |
4 ± |
0 ± 0.0 |
yes |
1 ± 0.6 |
0 ± 0.0 |
yes |
9 ± 2.9 |
9 ± 3.0 |
no |
2 ± 1.2 |
0 ± 0.0 |
yes |
1 ± 1.0 |
1 |
yes |
|
50 |
NT |
NT |
|
NT |
NT |
|
14 ± 4.6 |
11 ± 3.2 |
no |
NT |
NT |
|
NT |
NT |
|
|
150 |
NT |
NT |
|
NT |
NT |
|
10 ± 1.0 |
15 ± 2.3 |
no |
NT |
NT |
|
NT |
NT |
|
|
500 |
NT |
NT |
|
NT |
NT |
|
9 ± 1.0 |
8 ± 3.8 |
no |
NT |
NT |
|
NT |
NT |
|
|
1500 |
NT |
NT |
|
NT |
NT |
|
2 ± 1.2 |
6 ± 2.1 |
no |
NT |
NT |
|
NT |
NT |
|
|
5000 |
NT |
NT |
|
NT |
NT |
|
0 ± 0.0 |
0 ± 0.0 |
yes |
NT |
NT |
|
NT |
NT |
|
|
Positive control |
130 ± 12.9 |
325 ± 21.2 |
|
574 ± 71.8 |
2430 ± 57.7 |
|
705 ± 27.2 |
307 ± 50.5 |
|
373 ± 26.0 |
306 ± 14.0
|
|
655 ± 52.2 |
493 ± 27.2 |
|
|
*solvent control with DMSO
NT = not tested at this dose level
Table 3: Positive control data 2002
Strain S9-Mix |
TA100 |
TA1535 |
WP2uvrA- |
TA 102 |
TA98 |
TA1537 |
||||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Mean |
460 |
1880 |
347 |
310 |
621 |
866 |
1126 |
858 |
136 |
239 |
1953 |
453 |
SD |
118.2 |
594.3 |
204.0 |
119.7 |
235.5 |
350.5 |
289.4 |
169.5 |
38.2 |
74.7 |
803.1 |
145.9 |
Min |
235 |
499 |
80 |
91 |
185 |
210 |
686 |
568 |
66 |
91 |
486 |
140 |
Max |
952 |
3397 |
1385 |
810 |
1295 |
3406 |
2456 |
2009 |
323 |
507 |
4622 |
1365 |
Table 4: Positive control data 2003
Strain S9-Mix |
TA100 |
TA1535 |
WP2uvrA- |
TA 102 |
TA98 |
TA1537 |
||||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Mean |
429 |
1529 |
297 |
305 |
649 |
656 |
1068 |
911 |
174 |
249 |
1273 |
370 |
SD |
108.1 |
493.1 |
156.8 |
82.6 |
175.7 |
264.4 |
230.0 |
183.8 |
64.6 |
72.2 |
623.1 |
109.9 |
Min |
197 |
485 |
98 |
162 |
273 |
136 |
698 |
559 |
64 |
87 |
262 |
148 |
Max |
849 |
3662 |
1099 |
625 |
1198 |
1373 |
1886 |
1887 |
410 |
465 |
3704 |
759 |
Table 5: Negative (solvent/vehicle) historical control data (2002)
Strain S9-Mix |
TA100 |
TA1535 |
WP2uvrA- |
TA 102 |
TA98 |
TA1537 |
||||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Mean |
91 |
100 |
20 |
17 |
23 |
27 |
322 |
349 |
22 |
35 |
12 |
17 |
SD |
16.6 |
18.0 |
5.5 |
4.3 |
4.8 |
5.3 |
47.7 |
34.6 |
5.2 |
6.8 |
4 |
5 |
Min |
61 |
68 |
8 |
8 |
10 |
14 |
183 |
255 |
11 |
13 |
4 |
5 |
Max |
160 |
162 |
38 |
37 |
47 |
45 |
414 |
449 |
44 |
66 |
29 |
38 |
Table 6: Negative (solvent/vehicle) historical control data (2003)
Strain S9-Mix |
TA100 |
TA1535 |
WP2uvrA- |
TA 102 |
TA98 |
TA1537 |
||||||
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Mean |
98 |
106 |
20 |
15 |
23 |
28 |
331 |
365 |
20 |
30 |
10 |
14 |
SD |
20.7 |
23.4 |
8.5 |
3.9 |
5.6 |
7.0 |
38.2 |
29.0 |
5.1 |
7.1 |
3.9 |
5.0 |
Min |
61 |
64 |
8 |
7 |
11 |
13 |
233 |
264 |
10 |
15 |
3 |
3 |
Max |
165 |
191 |
45 |
39 |
44 |
57 |
400 |
422 |
52 |
53 |
26 |
32 |
Applicant's summary and conclusion
- Conclusions:
- In the present study conducted according to OECD guideline 471, 4 Salmonella thypimurium strains and one Escherichia coli strain were exposed to 5-Fluorocytosine at the following concentrations: Salmonella strains: 0.05, 0.15, 0.5, 1.5, 5, 15, 50 µg/plate E. coli strain: 15, 50, 150, 500, 1500, 5000 µg/plate in two independent experiments. Since the validity criteria were fulfilled and there were no doubling of the revertant number, the substance is considered non-mutagenic under the present conditions. Thus, no classification is needed according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to mutagenicity.
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