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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 279-317-3 | CAS number: 79828-43-6
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Principles of method if other than guideline:
- None
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
- EC Number:
- 279-317-3
- EC Name:
- Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
- Cas Number:
- 79828-43-6
- Molecular formula:
- C38H18Cl2CrN16O20S4.5Na
- IUPAC Name:
- Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
Method
- Target gene:
- Salmonella typhimurium histidine (his) reversion system
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: his(+), uvrB(-), rfa(+), R factor(+)for TA 98 and TA 100; R factor(-)for TA 1535 and TA 1537
- Species / strain / cell type:
- E. coli, other: E.coli WP2P and WP2PuvrA
- Additional strain / cell type characteristics:
- other: uvrA mutation
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix (Rat liver enzymes)
- Test concentrations with justification for top dose:
- 100 - 5000 µg/plate
- Vehicle / solvent:
- water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- for all strains with S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535 without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Acridine Mutagen ICR191
- Remarks:
- TA 1537 without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Daunomycin HCl
- Remarks:
- TA 98 without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- E. coli WP2P without S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- E. coli WP2P uvrA· without S9
- Details on test system and experimental conditions:
- A solution of the test compound (as supplied) was prepared in sterile (filtered: Milli-Q/RO) water to yield a w/v concentration of 50.00 mg/ml.
This was then diluted with water to give additional solutions of 25 mg/ml, 10 mg/ml, 5.0 mg/ml, 2.0 mg/ml and 1.0 mg/ml. Fresh stock solutions and dilutions were prepared as necessary for each experiment.
Water was also included as the negative (solvent) control.
The mutagenicity assays were conducted using the Salmonella bacterial mutation assay as described by Maron and Ames (1983), as updated by the United Kingdom Environmental Mutagen Society's sub-committee on Guidelines for Mutagenicity Testing (Gatehouse et al, 1990) (see Appendix A). The four Salmonella tester strains (TA1535, TA1537, TA98 and TA100) and two E.coli strains (WP2P and WP2PuvrA) used in this assay have been fully described in the literature (Ames et al 1975, and references therein; Venitt and Crofton-Sleigh, 1979).
The sample of Substance S70767 was assayed twice using the standard plate incorporation protocol over a dose range of 5000 - 100 µg per plate using all six strains (in a total of three separate experimental runs), both in the presence and absence of a liver S9-mix prepared from Phenobarbital/ beta-Naphthaflavone-induced Alderley Park (Alpk:APfSD) rats.
The incubation period for each experiment was 3 days (at 37°C).
For each experiment, positive control compounds were tested to validate the bacterial strains and to confirm the activity of each batch of S9-mix used.
Revertant colonies were counted using an automated electronic colony counter (AMS 40-10 Image Analyser fitted with appropriate software, Analytical Measuring Systems Ltd). - Evaluation criteria:
- Test data from individual experiments are considered valid if:
a) the concurrent solvent control data are acceptable;
b) the positive control data show unequivocal positive responses;
c) at least the lowest test compound dose shows no evidence of toxicity, and at least three test doses show no significant toxicity (ie significant loss of background growth and/or reductions in colony numbers).
Failure of one or more tester strain/59 combinations does not invalidate the data for the remainder of a concurrent experiment.
A positive response in a (valid) individual experiment is achieved when one or both of the following criteria are met:
a) a statistically significant dose-related increase in the mean number of revertant colonies is obtained;
b) a two-fold or greater increase in the mean number of revertant colonies (over that observed for the concurrent solvent control plates) which is
statistically significant, is observed at at least one dose level.
A negative result in a (valid) individual experiment is achieved when:
a) There is no statistically significant dose-related increase in the mean number of revertant colonies per plate observed for the test compound; and
b) in the absence of any such dose response, no increase in colony numbers is observed (at any test dose) which exceeds 2x the concurrent solvent control.
For a positive response in an individual experiment to be considered indicative of an unequivocal positive, ie mutagenic, result for that strain/59 combination, then the observed effect(s) must be consistently reproducible. - Statistics:
- All derived calculations (ie mean colony count/plate; standard deviation, etc) shown in the results tables were carried out by computer.
Counts from contaminated plates are not included in these calculations.
An assessment of statistical significance was carried out using a one-tailed Student's t-test (Ehrenberg 1984). The corresponding probability for each dose level was derived by computer using the appropriate degrees of freedom. Values of p<0.01 are treated as significant, with values of 0.01<=p<0.05 being indicative of a possible effect.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks:
- but tested up to limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks:
- but tested up to limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- ambiguous
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks:
- but tested up to limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- In two separate assays, the compound induced significant, reproducible increases in the observed number of revertant colonies in strains TA1535, TA1537, TA98, TA100 and WP2P both in the presence or absence of an auxiliary metabolising system (S9). Limited activity was observed in strain WP2PuvrA both in the presence and absence of S9.
The positive controls for each experiment induced the expected responses, indicating the strains were responding satisfactorily in each case.
Applicant's summary and conclusion
- Conclusions:
- The test substance gave a positive, ie mutagenic response in S.typhimurium strains TA1535, TA1537, TA98 and TA100 and in E.coli strain WP2P in both the presence and absence of S9. Limited activity was observed in E.coli strain WP2PuvrA in both the presence and absence of S9.
- Executive summary:
A study was performed to determine the mutagenecity of Substance S70767 according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) and OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay). Substance S70767 has been evaluated in a bacterial mutagenicity assay (Gatehouse et al, 1990: based on Maron and Ames (1983)) using four strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and two strains of Escherichia coli (WP2P and WP2PuvrA), following protocols complying with OECD Guideline Numbers 471 and 472 (OECD, 1983a and 1983b) and with the United Kingdom Department of Health Guidelines (DoH, 1989).
In two separate experiments, the compound induced significant, reproducible increases in the observed numbers of revertant colonies in all of the tester strains used, both in the presence or absence of an auxiliary metabolising system (S9). In each experiment, the positive controls responded as expected indicating that the assay was performing satisfactorily. Under the conditions of this assay, Substance S70767 therefore gave a positive, ie mutagenic response in S.typhimurium strains TA1535, TA1537, TA98 and TA100 and in E.coli strain WP2P in both the presence and absence of S9. Limited activity was observed in E.coli strain WP2PuvrA in both the presence and absence of S9.
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.