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EC number: 207-321-7 | CAS number: 462-06-6
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames-Test: negative; similar to OECD TG 471; 2021; no GLP; K2; Salmonella typhimurium strains TA 1535, TA 1538, TA 100, TA 1537 and TA 98; no Escherichia coli strain; with and without metabolic activation
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- AMES
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium, other: TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix from PCB-induced rat liver
- Test concentrations with justification for top dose:
- 0.08, 0.16, 0.32, 0.64, 1.28, 2.56, 5.12 or 10.24 µI/plate
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoantharcene
- Details on test system and experimental conditions:
- The test was performed in duplicate and repeated at least 3 times separately. Plates were inverted and incubated at 37°C in the dark for 3 days. Colonies of his+ revertants were counted after incubation.
- Evaluation criteria:
- Chemicals inducing more than twice the number of revertant colonies on the control plate were considered as mutagenic.
- Species / strain:
- S. typhimurium, other: TA 98, TA 1538, TA 1537, TA 100 and TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 5.12 µl/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Conclusions:
- Fluorobenzene was not mutagenic in any of the strains tested either with or without metabolic activation.
Reference
Number of revertant colonies in Ames test with fluorobenzene in S. typhimurium TA 98, TA 1538, TA 1537, TA 100 and TA 1535:
Compound |
Dose/plate |
His+revertants/plate |
|||||||||
TA 98 |
TA 1538 |
TA 1537 |
TA 100 |
TA 1535 |
|||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
||
DMSO |
0.05 ml |
28±6 |
30±5 |
22±7 |
24±5 |
8±3 |
11±4 |
181±23 |
175±36 |
32±8 |
30±9 |
ENNG |
2 µg |
- |
- |
- |
- |
- |
- |
1994±377 |
- |
- |
- |
10 µg |
- |
- |
- |
- |
- |
- |
- |
- |
2489±287 |
- |
|
2-NF |
2 µg |
1798±258 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
5 µg |
- |
- |
1659±228 |
- |
- |
- |
- |
- |
- |
- |
|
9-AA |
100 µg |
- |
- |
- |
- |
1288±198 |
- |
- |
- |
- |
- |
2-AA |
5 µg |
- |
1249±202 |
- |
753±62 |
- |
132±36 |
- |
1549±269 |
- |
174±21 |
Fluorobenzene |
0.08 µl |
28±3 |
29±4 |
28±4 |
32±6 |
10±3 |
9±2 |
184±19 |
196±21 |
33±3 |
31±3 |
0.16 µl |
31±4 |
33±8 |
24±3 |
22±4 |
10±2 |
10±3 |
165±12 |
188±16 |
30±3 |
51±7 |
|
0.32 µl |
33±5 |
28±4 |
21±3 |
27±5 |
12±4 |
8±1 |
157±22 |
195±19 |
40±5 |
41±8 |
|
0.64 µl |
30±3 |
26±3 |
23±4 |
27±4 |
10±3 |
8±2 |
180±16 |
204±28 |
38±4 |
31±4 |
|
1.28 µl |
28±3 |
33±5 |
27±5 |
20±3 |
11±3 |
9±2 |
160±19 |
172±15 |
31±3 |
32±3 |
|
2.56 µl |
26±3 |
21±3 |
18±2 |
24±4 |
9±2 |
7±1 |
204±18 |
185±17 |
33±4 |
30±3 |
|
5.12 µl |
15±4* |
26±4 |
8±4* |
18±2 |
2±4* |
8±2 |
172±14 |
191±24 |
34±5 |
36±6 |
|
10.24 µl |
0* |
0* |
0* |
0* |
0* |
0* |
0* |
0* |
0* |
0* |
Data represent the results of 3 separate experiments and give the mean values of 3 plates. The number of revertant colonies indicates mean±SD. All these revertant colonies were counted after 68-72 h incubation. * indicates toxic effects.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
MNT: negative; according to OECD TG 474; 1991; GLP; K1; NMRI mice
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Tierfarm Füllinsdorf, CH-4414 Füllinsdorf/Basel, Switzerland
- Age at study initiation: minimum 10 weeks
- Weight at study initiation: approx. 30 g
- Fasting period before study: 18 hours before treatment
- Housing: single housing in Makrolon Type I cages
- Diet: pelleted standard diet (ALTROMIN 1324, D-4937 Lage/Lippe) ad libitum except during fasting period
- Water: tap water ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: corn oil
- Justification for choice of solvent/vehicle: relative nontoxicity for the animals
- Concentration of test material in vehicle:
- Amount of vehicle: 10 ml/kg - Duration of treatment / exposure:
- not specified
- Frequency of treatment:
- once
- Post exposure period:
- 24, 48 and 72 hours
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 6 animals/sex/dose were treated, 5 animals/sex/dose were evaluated
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide (CPA)
- Route of administration: orally, once
- Doses / concentrations: 30 mg/kg bw - Tissues and cell types examined:
- 1000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in the same sample.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
A preliminary study on acute toxicity .was performed with the same strain and under identical conditions as in the mutagenicity study. It is generally recommended to use the maximum tolerated dose or the highest dose that can be formulated and administered reproducibly. The volume to be administered should be compatible with physiological space available. The maximum tolerated dose level was determined to be the dose that caused toxic reactions, without having major effects on survival within 72 hours.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
Approximately 18 hours before treatment with the test article the animals received no food but water ad libitum. At the beginning of the treatment the animals were weighed and the individual volume to be administered was adjusted to the animal's body weight. The animals received the test article once. Twelve animals, six males and six females, were treated per dose group. Sampling of the bone marrow was done 24, 48 and 72 hours after
treatment.
DETAILS OF SLIDE PREPARATION:
The animals were sacrificed by cervical dislocation. The femora were removed, the epiphyses were cut off and the marrow was flushed out with fetal calf serum, using a 5 ml syringe. The cell suspension was centrifuged at 1,500 rpm for 10 minutes and the supernatant was discarded. A small drop of the resuspended cell pellet was spread on a slide. The smear was air-dried and then stained with May-Grünwald (MERCK, D-6100 Darmstadt)/Giemsa (Gurr, BDH Limited Poole, Great Britain). Cover slips were mounted with EUKITT (KINDLER, D-7800 Freiburg). At least one slide was made from each bone marrow sample.
METHOD OF ANALYSIS:
Evaluation of the slides was performed using NIKON microscopes with 100x oil immersion objectives. 1000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in the same sample and expressed in normochromatic erythrocytes per 1000 the PCEs. The analysis was performed with coded slides. Five animals per sex and group were evaluated as described. The remaining animal of each test group was evaluated in case an animal had died in its test group spontaneously or due to gavage error. - Evaluation criteria:
- A test article is classified as mutagenic if it induces a statistically significant increase in the number of micronucleated polychromatic erythrocytes at for at least one of the test points. A test article producing no statistically significant increase in the number of micronucleated polychromatic erythrocytes at any of the test points is considered non-mutagenic in this system. This can be confirmed by means of the nonparametric Mann-Whitney test. However, both biological and statistical significance should be considered together.
- Statistics:
- Statistical significance at the five per cent level (p < 0.05) was evaluated by means of the non-parametric Mann-Whitney test.
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- One out of 18 treated animals died.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
In a pre-experiment 4 animals (2 males, 2 females) received orally a single dose of 5000 mg/kg bw Fluorbenzol suspended in corn oil. The volume administered was 10 ml/kg bw.
- Dose: 5000 mg/kg
- Clinical signs of toxicity in test animals: reduction of spontaneous activity (1 male and 1 female 24 hours post-treatment), eyelid closure (2 males and 1 female 6 hours post-treatment; 1 male and 1 female 24 hours post-treatment), apathy (1 female 24 hours post-treatment), death (1 female 48 hours post-treatment).
RESULTS OF DEFINITIVE STUDY
The mean number of normochromatic erythrocytes was increased after treatment with the test article at preparation interval 48 h as compared to the mean value of NCEs of the corresponding negative control, indicating that Fluorbenzol had cytotoxic properties. In comparison to the corresponding negative controls there was no significant enhancement in the frequency of the detected micronuclei at any preparation interval after application of the test article. The mean values of micronuclei observed after treatment with Fluorbenzol were in the same range as compared to the negative control groups. - Conclusions:
- The test article did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse.
Reference
Summary of results:
Test Group |
Dose (mg/kg bw) |
Sampling time (h) |
PCEs with micronuclei (%) |
Range ofmicronuclei in 1000 PCE per animal |
PCE/NCE |
Negative control |
0 |
24 |
0.10% |
0-4 |
1000/861 |
Fluorbenzol |
5000 |
24 |
0.07% |
0-2 |
1000/830 |
Positive control |
30 |
24 |
1.36% |
6-25 |
1000/766 |
Negative control |
0 |
48 |
0.06% |
0-3 |
1000/941 |
Fluorbenzol |
5000 |
48 |
0.10% |
0-3 |
1000/1316 |
Negative control |
0 |
72 |
0.12% |
0-4 |
1000/697 |
Fluorbenzol |
5000 |
72 |
0.20% |
0-3 |
1000/760 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008.
The test substance was negative in the Ames assay when investigated in Salmonella typhimurium strains with and without metabolic activation. Also, the test substance did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse (MNT).
As a result, the substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008, as amended for the seventeenth time in Regulation (EC) No. 2021/849.
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