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EC number: 256-917-3 | CAS number: 51022-74-3
- 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:
- 1978-10-23 1979-01-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-[[2-[2-[2-[2-(3-carboxy-2,4,6-triiodoanilino)-2-oxoethoxy]ethoxy]ethoxy]acetyl]amino]-2,4,6-triiodobenzoic acid;(2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol
- Cas Number:
- 68890-05-1
- Molecular formula:
- C29H35I6N3O14
- IUPAC Name:
- 3-[[2-[2-[2-[2-(3-carboxy-2,4,6-triiodoanilino)-2-oxoethoxy]ethoxy]ethoxy]acetyl]amino]-2,4,6-triiodobenzoic acid;(2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol
Constituent 1
- Specific details on test material used for the study:
- - Name used in the test report: Biliscopin minor
- Physical appearance: Clear colorless liquid
Method
- Target gene:
- Histidine locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98 and TA100
- Details on mammalian cell type (if applicable):
- MEDIA USED
- Type and identity of media used: Selective agar plates
- Species / strain / cell type:
- Saccharomyces cerevisiae
- Remarks:
- D4
- Details on mammalian cell type (if applicable):
- MEDIA USED
- Type and identity of media used: Selective agar plates
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 homogenate
- Test concentrations with justification for top dose:
- 1, 5, 10, 50, 100 and 500 µL
- Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (50 µL / plate)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-METHYL,N-NITRO,N—NITROSOGUANIDINE
- Remarks:
- -S9: TA1535, TA100, D4,10 µg / plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (50 µL / plate)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- -S9, TA1537, 50 µg / plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (50 µL / plate)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- -S9, TA1538, TA98, 10 µg / plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (50 µL / plate)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine
- Remarks:
- +S9: TA1535, TA1537, TA1538, TA98, TA100, D4, 2.5 µg / plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Plate Test: Agar Incorporation: Approximately l08 cells from an overnight culture of each indicator strain were added to separate test tubes containing 2.0 ml molten nagar supplemented with biotin and a trace of histidine. For nonactivation tests, at least 4 dose levels of the test compound
added to the contents of the appropriate tubes and poured over the surfaces of selective-agar plates. In activation tests, at least 4 dose levels of the test chemical were added to the appropriate tubes with cells. Just prior to pouring, an aliquot of reaction mixture (0.5 ml containing the 9,000 x g_liver homogenate)
was added to each of the activation overlay tubes, which were then mixed, and the contents poured over the surface of a
minimal agar plate and allowed to solidify. The plates were incubated for 48 hrs at 37°C and scored for the number of colonies growing on each plate“ 04 yeast plates were incubated at 30°C for 3>5 days and then scored. Positive and solvent controls using both directly active positiva chemicals and those that require metabolic activation were run with each assay‘
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: Relative total growth - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- EVALUATION CRITERIA
- Evaluation Criteria for Ames Assay: Because the procedures used to evaluate the mutagenicity of the test chemical are semiquantitative, the criteria used to determine positive effects are inherently subjective and are based primarily on a historical data base."Most data sets are evaluated using the
following criteria: .
- l. Strains TA-l535, TA-1537 and TA-1538: If the solvent control value is within the normal range, a chemical that.produces a positive dose response over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.
- Strains TA-98, TA-lOO and D4: If the solvent control value is within the-normal range, a chemical that produces a positive dose response over three concen rations with the highest increase equal to twice the solvant control value for TA-lOO and.2-3 times the solvent control value for strains TA-98 and D4 is considered to be mutagenic. For these strains, the dose-response increase should start at approximately the solvent control value. - Statistics:
- Not specified
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA100 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Saccharomyces cerevisiae
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In this study, the test compound, Biliscopin minor, did not demonstrate genetic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions.
- Executive summary:
In a reverse bacterial mutation assay, the test item was examined for mutagenic potential employing Salmonella typhimurial strains TA1535, TA1537, TA1538, TA98 and TA100 and Saccharomyces cereviciae strain D4 at test concentrations of 1, 10, 50, 100 and 500 µL/plate.
The test compound exhibited slight toxicity with the strains TA1535 and TA100 at the 500 µL dose level. The results.of the tests conducted on the compound in the absence of a metabolic activation system were all negative. The results of the tests conducted on the compound in the presence of a rat liver activation system were all negative. Hence, in this study, it was demonstrated that the test substance is non mutagenic.
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