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EC number: 277-475-8 | CAS number: 73455-75-1
- 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his-locus
- 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:
- Aroclor 1254 induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 1st experiment: 0; 20; 100; 500; 2500 and 5000 µg/plate
2nd experiment: 0; 500; 1000; 1500; 2000 and 2500 µg/plate
3rd experiment: 0; 0.8; 4; 20; 100 and 500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- strains TA 1535 and TA 100, without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- strain TA 98, without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- strain TA 1537, without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- strain E. coli WP2 uvrA, without S9 mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all strains, with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 minutes at 37°C (preincubation method only)
- Exposure duration: 48-72 hours at 37°C
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants, clearing or diminution of the background lawn (= reduced his- or trp- background growth), reduction in the titer - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
* A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
* The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 500 - 2500 µg/plate onward (standard plate test) and from 100 µg/plate (preincubation test) (strain and test condition dependent)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 500 - 2500 µg/plate onward (standard plate test) and from 100 µg/plate (preincubation test) (strain and test condition dependent)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Test substance precipitation was found from about 500 µg/plate onward.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In a GLP-compliant study, performed according to OECD guideline 471, the test substance was tested for its mutagenic potential based an the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay.The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate.The test article was tested at the following concentrations: 20.0- 5000 µg/plate(SPT) and 0.8 - 500 µg/plate(PIT).
Precipitation of the test substance was found from about 500 µg/plate onward. A bacteriotoxic effect (reduced background growth, decrease in the number of revertants, reduction in the titer) was observed in the standard plate test depending on the strain and test conditions from about 500 - 2500 µg/plate onward. In the preincubation assay bacteriotoxicity was observed depending on the strain and test conditions at doses> 100 µg/plate. According to the results of the present study, the test substance did not lead to an increase in the number of revertant colonies either without S-9 mix or after adding a metabolizing system in three experiments carried out independently of each other (standard plate test and preincubation assay). Thus, under the experimental conditions chosen here, it is concluded that the substance not a mutagenic agent in a bacterial reverse mutation test.
The substance was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro (OECD 476, GLP). Two independent experiments were carried out, both with and without the addition of liver S9 mix from phenobarbital- and β-naphthoflavone induced rats (exogenous metabolic activation). Based on an initial range-finding cytotoxicity test for the determination of the experimental doses and taking into account the cytotoxicity actually found in the main experiments,concentrations up to 0.5 mg/ml were tested.Following attachment of the cells for 20 - 24 hours, cells were treated with the test substancefor 4 hours in the absence and presence of metabolic activation. Subsequently, cells were cultured for 6 - 8 days and then selected in 6-thioguanine-containing medium for another week.
Finally, the colonies of each test group were fixed with methanol, stained with Giemsa and counted. The negative controls gave mutant frequencies within the range expected for the CHO cell line. Both positive control substances, ethyl methanesulfonate (EMS) and 7,12-dimethylbenz[a]anthracene (DMBA), led to the expected increase in the frequencies of forward mutations.
The test substance was poorly soluble. Hence homogeneous test substance preparations in culture medium were add to the cultures. In both experiments in the absence and the presence of metabolic activation at least the highest concentrations tested for gene mutations were clearly cytotoxic. Based on the results of the present study, the test substance did not cause any biologically
relevant increase in the mutant frequencies either without S9 mix or after the addition of a metabolizing system in two experiments performed independently of each other.
Regarding clastogenicity, experimental data on the target substance is not available. No structural alert for protein binding or DNA damage was identified by the profilers in the OECD QSAR toolbox v3.3.0.152.
(Q)SAR modelling using the software TIMES-predicted the substance to be non clastogenic, with the limitation that the structure is out of the applicability domain of the model as it contains a number of fragments unknown to the training set of the model.
No hazard for clastogenicity was identified for copperphthalocyanine both in valid in vitro and in vivo studies. No hazard for clastogenicity in vivo (OECD 474, GLP) was identified for the higher substituted analogue (CAS 108300-90-9). Although the substance has a higher molecular weight, it caused systemic toxicity at lower doses than the target substance in the subacute oral toxicity study in rats. It is therefore considered suitable for the assessment of clastogenicity in vivo.
Absence of clastogenicity in vivo was also observed for a similar UVCB substance (CAS81457-65-0)which has a sulphonamide bond instead of an ionic bond and which contains an excess of free sulonic acid groups. It is of lower water but of much higher octanol solubility. In the in vivo micronucleus study, it was applied using peanut oil as a vehicle. In this vehicle and species, it caused mortality at high doses indicating that systemic uptake has taken place.
Reliable experimental data on related alkylamine cations is described in the US HPV programme and its published robust study summaries (Doc no. 201-14978 December 29, 2003). For example,no hazard for clastogenicity was identified for the analogue amine (Cis-9-Octadecenylamine, CAS 112-90-3).
Taking into account all available data, the target substance is considered to be non clastogenic in a weight-of-evidence approach. A datamatrix and a more detailed read-across justification is attached both in this endpoint summary and to the Chemical Safety report.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for genetic toxicity under Directive 67/548/EEC.
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. As a result the substance is not considered to be classified for genetic toxicity under Regulation (EC) No. 1272/2008.
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.
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