Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 407-560-9 | CAS number: 107934-68-9 CAF
- 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
Additional information
The in-vitro genetic toxicity of 4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (CAS 107934-68-9) was assessed in a bacterial reverse mutation assay (Ames test) (Riccio, 1988). The study was performed equivalent to OECD 471, but without the required TA 102 or E. coli strain and for the characterisation of S9-mix only 2-aminoanthracene was used. The plate incorporation method was applied using S. typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100 at concentrations up to 5000 µg/plate with and without metabolic activation. The test substance did not induce reversions in any of the S. typhimurium strains with or without metabolic activation. Cytotoxicity was observed at 5000 µg/plate without metabolic activation in the first experiment with TA 1537. All the positive controls were valid. Precipitation was seen from 500µg/plate and upwards, for 1000 and 5000 µg/plate it interfered with counting of colonies wherefore plates were handcounted at those concentrations.
In addition to the bacterial reverse mutation assay a test in saccharomyces cerevisae equivalent to OECD 480 was performed with 4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline). Saccharomyces cerevisae D3 was tested with 0.05, 0.1, 0.5, 1.0, 2.5% (w/v) in the presence and absence of metabolic activation. The cells from the overnight culture were preincubated with the test material for 4 h at 30°C. After pre-incubation serial dilutions of the mixture were plated on agar plates for 3 days at 30°C and 1 day at 4°C. Thereafter the plates were scanned with a microscope and the red colonies, indicative of adenine-deficient homozygosity, were counted. The positive controls (-S9: 1,2,3,4 -diepoxybutane; +S9: sterigmatocystin) were valid. No genotoxic and cytotoxic effects were observed in the experiments with the negative control and the test substance.
The potential of 4,4'-(9H-fluoren-9-ylidene)bis(2 -chloroaniline) (CAS 107934-68-9) to induce chromosomal aberrations was assessed using peripheral human lymphocytes, in a study performed according to OECD 473 (Adams, 1991). The lymphocytes were exposed to 3.1, 12.5, and 30 µg/mL (without S9-mix, 24 h treatment) or 12.5, 50, and 100 µg/mL (with S9-mix, 3 h treatment) test substance diluted in DMSO. The test material did not induce a statistically significant increase in the frequency of cells with chromosome aberrations, with or without metabolic activation. Reduction of mitotic index to 23.9% of controls was seen at 30 µg/mL in the absence of S9 mix. Precipitation was observed at concentrations from 100 µg/mL, while no cytotoxicity was noted at any concentration. The vehicle and positive controls were valid.
An in vitro mammalian cell gene mutation assay was performed using 4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline) (CAS 107934-68-9), according to OECD 476 (Adams, 1991). Mouse Lymphoma cells were treated with the test substance at concentrations of up to 125 µg/mL for 3 h both with and without metabolic activation. Duplicate cultures were used in 2-3 independent experiments each, in the absence or presence of S9-mix, respectively. In the first experiment no increase of the induced mutant frequency (IMF) exceeding the Global Evaluation Factor of 90 (GEF) was observed up to 125 µg/mL and a relative survival of 8% in the absence of S9-mix. In a second experiment two concentrations of 50 and 87.5 µg/mL were included for a more narrow distribution at higher concentrations, yielding a IMF of 94 and 133, respectively. As both concentrations led to a relative survival <10% a third test including 40 µg/mL was performed. A IMF of 87 and a relative survival of 9% was observed after treatment with 40 µg/mL. In all 3 experiments 25 µg/mL was the highest concentration tested yielding a relative survival >10%. IMF values of 18, 65, and 49 were observed after treatment with 40 µg/mL with a relative survival of 14%, 22%, and 13%, respectively.
In the presence of S9-mix no increase of the IMF over the GEF was observed up to concentrations of 125 µg/mL and down to a relative survival of 14%.
In summary, no mutagenic effects were observed in the presence or absence of S9-mix. IMF exceeding the GEF were only observed in the presence of cytotoxicity (relative survival <10%) and in the absence of S9 -mix. Testing in the range of 10 -100% relative survival revealed no positive results. Therefore, the evaluation criteria for a positive result were not fulfilled.
In conclusion,4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline) is considered to be not genotoxic based on the negative results in an Ames test and Saccharomyces cerevisae gene mutation test as well as in a chromosome aberration test and mouse lymphoma assay.
Justification for selection of genetic toxicity endpoint
No study was selected, since all available in vitro genetic toxicity studies were negative.
Short description of key information:
Gene mutation in bacteria (similar to OECD 471, Ames test with S. typhimurium TA 100, TA 1535, TA 98, TA 1537): negative with and without metabolic activation
Gene mutation in yeast (similar to OECD 480, S. cerevisiae): negative with and without metabolic activation
Chromosome aberration in mammalian cells (similar to OECD 473): negative with and without metabolic activation
Gene mutation in mammalian cells (according to OECD 476): negative with and without metabolic activation
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the negative results in in-vitro gene mutation assays in yeast, bacteriae, and mammalian cells and the lack of clastogenic properties in a chromosome aberration assay, 4,4´-(9H-fluoren-9 -ylidene)bis(2 -chloroaniline) does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.