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EC number: 204-650-8 | CAS number: 123-77-3
- 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 mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study methodology was broadly consistent with modern OECD test guideline 476, and a claim of GLP compliance was made, however as the guideline itself was not directly followed, and as the study report is missing a few very important details (test substance purity, for example), the study cannot be considered reliable without restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- : No lot number, purity or expiry date was indicated.
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- C,C'-azodi(formamide)
- EC Number:
- 204-650-8
- EC Name:
- C,C'-azodi(formamide)
- Cas Number:
- 123-77-3
- Molecular formula:
- C2H4N4O2
- IUPAC Name:
- diazene-1,2-dicarboxamide
- Details on test material:
- - Name: Celogen AZ 130
- Description: yellow powder
no data on purity or batch number
- Source: Pharmakon Research
- Date of recepetion: February 23, 1984
- Storage: at room temperature in the container received from the sponsor.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Cell culture: Chinese hamster ovary cells, clone K1, subclone BH4, designated CHO-K1-BH4, from Dr. AbrahamW. Hsie, Biology Division, Oak Ridge National Laboratories, PO Box Y, Oak Ridge, Tennessee 37380
- Type and identity of media: F12FCM5 (Ham's F12 supplemented with 5% dialyzed and heat-inactivated bovine serum)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced male Sprague-Dawley rat liver homogenate with the appropriate buffer and cofactors
- Test concentrations with justification for top dose:
- cytotoxicity: 0.01,0.04, 0.13, 0.4, 1.3, 4.0, 13.3, 40, 133 and 400 µg/ml
mutation assay: 5, 16.7, 50, 167 and 500 µg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO;
- Justification for choice of solvent/vehicle: solubility
All required dilutions were made with DMSO, Lot #741643, supplied by Fisher Scientific.
Dilutions were prepared the day of the test. Dosing solutions were used within two hours of preparation.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: ethyl methanesulfonate [EMS, 200 ug/ml (Sigma M0880)] with S9: dimethylnitrosamine [DMN, 100 ug/ml (Aldrich N2,500-1)]
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium;
DURATION
- Preincubation period:none
- Exposure duration: 19h
- Expression time (cells in growth medium): 8days
NUMBER OF REPLICATIONS:5
DETERMINATION OF CYTOTOXICITY
- Method: relative cell survival - Evaluation criteria:
- The mutant frequency, expressed as TGr mutants/10^6 clonable cells, was calculated by dividing the total number of mutant clones by the number of cells plated, corrected for the cloning efficiency (average of three plates) of the cells at the time of mutant selection.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Celogen AZ, was evaluated in a cytotoxicity prescreen with [2% (v/v)] and without S-9 at dose levels of 0.01, 0.04, 0.13, 0.4, 1.3, 4, 13.3, 40, 133 and 400 µg/ml. The 400 µg/ml dose approached the limit of solubility of the test article. The doses evaluated produced no detectable cytotoxicity to the CHO cell line without metabolic activation and produced 63.1% relative cell survival with metabolic activation at the 400 µg/ml level.
Based upon these findings, Celogen AZ, was evaluated in duplicate cultures in the mutation assay at dose levels of 5, 16.7, 50, 167 and 500 µg/ml with and without S-9.
There were no dose-dependent increases in the mutant frequencies of the cultures treated with the test article. The 500 µg/ml dose approximated the limit of solubility of the test article in DMSO. Therefore, the test article did not exhibit mutagenic activity under the conditions of the assay. This study fulfilled all the criteria of an acceptable assay.
Any other information on results incl. tables
Mutagenicity Data | ||||||
Control Cultures | ||||||
compound | µg/ml | S-9 | Relative Initial Survival (%) | Total No. of Mutants (5 plates) | Cloning Efficiency (%) | Mutant Frequency (Mutants/10^6 clonable cells) |
Untreated | (-) | 108.2 | 1 | 68.8 | 1.5 | |
Untreated | (-) | 91.8 | 0 | 60.3 | 0.0 | |
Untreated | (+) | 90.0 | 0 | 74.3 | 0.0 a | |
Untreated | (+) | 91 | 0 | 71. 7 | 0.0 a | |
DMSO | 10 | (-) | 118.2 | 1 | 82.2 | 1.2 |
DMSO | 10 | (-) | 86.2 | 1 | 72.3 | 1.4 |
DMSO | 10 | (+) | 82 | 2 | 65.2 | 3.1 |
DMSO | 10 | (+) | 98.9 | 8 | 50.3 | 15.9 |
EMS | 200 | (-) | 88.4 | 175 | 57.5 | 304.3 |
EMS | 200 | (-) | 82.7 | 149 | 43.3 | 344.1 |
DMN | 100 | (+) | 12.5 | 90 | 30.6 | 294.1 |
DMN | 100 | (+) | 10.9 | 74 | 41.2 | 179.6 |
Celogen AZ | 5 | (-) | 99 | 1 | 57.8 | 1.7 |
Celogen AZ | 5 | (-) | 105.6 | 1 | 75.3 | 1.3 |
Celogen AZ | 16.7 | (-) | 82.4 | 1 | 63.2 | 1.6 |
Celogen AZ | 16.7 | (-) | 64.9 | 2 | 57.5 | 3.5 |
Celogen AZ | 50 | (-) | 88.8 | 1 | 58.5 | 1.7 |
Celogen AZ | 50 | (-) | 83.2 | 0 | 46.3 | 0 |
Celogen AZ | 167 | (-) | 109.1 | 0 | 64.3 | 0.0 a |
Celogen AZ | 167 | (-) | 76.1 | 0 | 58.7 | 0.0 a |
Celogen AZ | 500 | (-) | 48.7 | 1 | 80.7 | 1.2 |
Celogen AZ | 500 | (-) | 54.5 | 10 | 65.2 | 15.3 |
Celogen AZ | 5 | (+) | 86.6 | 1 | 56.5 | 1.8 |
Celogen AZ | 5 | (+) | 74.2 | 1 | 60.2 | 1.7 |
Celogen AZ | 16.7 | (+) | 96.8 | 0 | 53 | 0 |
Celogen AZ | 16.7 | (+) | 116.4 | 1 | 54 | 1.8 |
Celogen AZ | 50 | (+) | 92 | 1 | 65.5 | 1.5 |
Celogen AZ | 50 | (+) | 90.4 | 2 | 34.8 | 5.7 |
Celogen AZ | 167 | (+) | 22.7 | 1 | 64.2 | 1.6 |
Celogen AZ | 167 | (+) | 26 | 1 | 64.2 | 1.6 |
Celogen AZ | 500 | (+) | 7.5 | 0 | 70.8 | 0.0 a |
Celogen AZ | 500 | (+) | 5.7 | 0 | 65.2 | 0.0 a |
a = No scorable mutants |
Applicant's summary and conclusion
- Conclusions:
- Celogen AZ did not exhibit mutagenic activity under the conditions of the assay.
- Executive summary:
Celogen AZ, was evaluated in the CHO/HGPRT Mammalian Cell Forward Gene Mutation Assay to determine its ability to induce mutations at the hypoxanthine-guanine phosphoribosyl transferase (HGPRT) locus in cultured Chinese hamster ovary (CHO) cells (Pharmakon Research International 1984, PH314 -UN-003 -84). Cytotoxicity of the test article was first estimated in a prescreen by exposing CHO cells to 10 levels of Celogen AZ in the presence and absence of metabolic activation. The metabolic activation mixture (S-9) contained 2% (v/v) of an Aroclor 1254-induced male Sprague-Dawley rat liver homogenate with the appropriate buffer and cofactors. Doses of 0.01, 0.04, 0.13, 0.4, 1.3, 4, 13.3, 40, 133 and 400 µg/ml were evaluated. The 400 µg/ml dose approached the limit of solubility of the test article. The doses evaluated produced no detectable cytotoxicity to the cell line without metabolic activation and resulted in 63.1% relative cell survival with metabolic activation at the 400 µg/ml dose.
Based upon these findings, Celogen AZ was evaluated in duplicate cultures in the mutation assay at dose levels of 5, 16.7, 50, 167 and 500 µg/ml with and without S-9. The 500 µg/ml dose approximated the limit of solubility of the test article in DMSO.
There were no dose-dependent increases in the mutant frequencies of the cultures treated with the test article. Therefore, the test article did not exhibit mutagenic activity under the conditions of the assay. This study fulfilled all the criteria of an acceptable assay.
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