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EC number: 404-910-2 | CAS number: 164578-14-7 PIGMENT ADDITIV C
- 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:
- Aug - Oct 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted 26 May 1983
- Deviations:
- no
- Remarks:
- E. coli or Salmonella th. TA102 is missing
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide
- EC Number:
- 404-910-2
- EC Name:
- 2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide
- Cas Number:
- 164578-14-7
- Molecular formula:
- C25H31N7O4
- IUPAC Name:
- N-[3-(diethylamino)propyl]-4-[(1E)-2-{2-oxo-1-[(2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)carbamoyl]propyl}diazen-1-yl]benzamide
- Test material form:
- solid: bulk
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat and hamster S9 mix
- Test concentrations with justification for top dose:
- 4, 20, 100, 500, 2500 and 5000 µg/plate (with 5000 µg/plate as highest test concentration required by guideline)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- congo red
- other: 2-Aminoanthracene (Ames/Prival Test), Benzidine (Prival)
- Details on test system and experimental conditions:
- The mutagenicity tests were conducted in the standard plate test (Ames Test) and in a modified preincubation test (Prival Test). The studies were performed in the absence and presence of a metabolising system derived from rat or hamster liver homogenate. A dose range from 8 different doses from 4 to 5000 µg/plate was used.
Two independent experiments for each test protocol (Ames; Prival; 3 plates per dose) were performed.
METHOD OF APPLICATION:
1. Ames Test:
in agar (plate incorporation)
2. Prival Test:
preincubation;
- Cell density at seeding (if applicable): 0.1 mL of an overnight broth culture of bacterial tester strain
DURATION
- Preincubation period: 30 min (Prival Test)
- Exposure duration: 48-72 h
SELECTION AGENT (mutation assays): Histidine
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: surviving fraction
- Any supplementary information relevant to cytotoxicity:
preliminary toxicity tests were performed with five or four tester strains using three plates per dose. A reduced rate of spontaeously occuring colonies as well as visible thinning of the bacterial lawn were used as indicator for toxicity. - Rationale for test conditions:
- based on pretest
- Evaluation criteria:
- according to OECD guideline
- Statistics:
- none
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- incomplete bacterial at 500 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- incomplete bacterial lawn at 500 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- incomplete bacterial lawn at 500 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- incomplete bacterial lawn at 300 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- incomplete bacterial lawn
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: observed at 2500 µg/plate and above - Remarks on result:
- other:
- Remarks:
- only tested with rat S9 mix
Applicant's summary and conclusion
- Conclusions:
- The test item increased the number of revertant colonies in tester strains Salmonella thyphimurium TA 98 and TA 1538 with an without metabolic activation (10% rat S9 mix): An increase in the number of revertants was also reported in Salmonella thyphimurium TA 98 with metabolic activation (30% rat S9 mix and 30% hamster S9 mix). Therefore, the test substance is considered to be mutagenic under the conditions described. However, based on the detailed results the biological relevance is unclear.
- Executive summary:
The test substance was tested for mutagenicity with Salmonella thyphimurium strains TA 100, TA 1535, TA 1537, TA 1538 and TA 98. The mutagenicity studies were conducted in the standard plate (Ames Test) and in a modified preincubation test (Prival Test). The studies were performed in the absence and in the presence of a metabolising system derived from rat or hamster liver homogenate. A dose range of 8 different doses from 4 to 5000 µg/plate was used. Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All positive control compounds gave the expected increase in the number of revertant colonies.
- Toxicity:
The test compound proved to be toxic to the bacterial strains at 2500 µg/plate. 5000 µg/plate was chosen as top dose level for the mutagencity study.
- Ames Test:
In the absence of metabolic activation the test item gave a dose dependent increase in the number of revertant colonies with the bacterial strains TA 1538 and TA 98. In the presence of metabolic activation (rat S9 mix, 10%) treatment of the cells with the test substance results in relevant increases in the number of revertant colonies with TA 98 and TA 1538.
- Prival Test:
In the presence of hamster liver S9 mix the preincubation method according to Prival and in the presence of rat liver S9 mix (30%) using the standard plate test the test compound resulted in increases in the number of revertant colonies with tester strain TA 98 (TA 1538 was not tested).
However, in case of TA 98 the increase in the number of revertants reached only barlely twice the value of the negative control while the revertant number in case of the positive coontrols was approx. 30fold (in case of 10% rat S9 mix) to 5.5 (in case of hamster S9 mix) depending on utilised positive control compound increased. Furthermore, it should be considered that the tester strain TA 98 contains the R-factor, the plasmid pKM 101, which increases error-prone DNA repair and therefore, artificially increases the susceptibility to DNA damages regardless if their origin. In contrast, no changes were observed in the number revertant colonies in case of the corresponding tester strain TA 1537 not containing the plasmid. Taking into account the before mentioned, the biological relevance and additionally the relevance for humans of the observed tendency to an increasing number of revertant colonies as reported for tester strains TA 98 and 1538 is unclear.
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