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EC number: 401-610-3 | CAS number: 122012-52-6 GENIPLEX A
- 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:
- 1985-09-13 to 1985-09-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well-documented study according to OECD 471 with minor deviations: only four strains of S. typhimurium (TA1535, TA1537, TA98, TA100) as indicated in the latest guideline were used, data on E.coli WP2 strains or S. typhimurium TA102 are lacking. However, since these strains were mainly included in the recent version of OECD 471 because the four formerly only recommended S. typhimurium strains TA1535, TA1537, TA98 and TA100 may not detect certain oxidising mutagens, cross-linking agents and hydrazines, and this mode of action is not likely to occur based on the chemical structure of the test item, this restriction is considered to be negligible.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- OECD Guideline for testing of chemicals no. 471:- Genetic Toxicology : Salmonella tvphimurium. Reverse Mutation Assay. Presumed of 1981.
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- self-declaration
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diamminediisocyanatozinc
- EC Number:
- 401-610-3
- EC Name:
- Diamminediisocyanatozinc
- Cas Number:
- 122012-52-6
- Molecular formula:
- C2H6N4O2Zn
- IUPAC Name:
- copper(2+) bis(carbonylazanide) diamine
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- his-
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 liver S9-Mix, induced by Aroclor 1254
Method of preparation of S9 mix
Species: Rat
Strain: CD (Sprague-Dawley-derived).
Source: Charles River UK Limited, Manston Road, Margate, Kent, England.
Age range: 7-8 weeks on arrival.
Weight range: 180-200 g on arrival.
Diet: Spratt's Laboratory Diet No. 1.
Number of rats used: 8
Stimulation of rat liver enzymes: Mixed-function oxidase systems in the rat liver were stimulated following a single i/p injection of Aroclor 1254 (diluted in Arachis oil to 200 mg/ml) at a dosage of 500 mg/kg. On the fifth day of induction, following an overnight starvation, the rats were killed and their livers aseptically removed.
Preparation of liver homogenate S-9: All steps were at 0-4°C using sterile solutions and glassware. The livers were placed in beakers containing 0.15 M KCl. After weighing, livers were transferred to a beaker containing 0.15 M KCl (the volume of KCl in ml was equivalent to 3 times the weight of liver in gram), minced with a sterile scalpel and homogenized in an MSE top-drive homogenizer. This homogenate was centrifuged for 10 minutes at 9000 x 'g' and the supernatant divided into 15 ml aliquots. These were frozen on dry ice and stored at -80°C, and tested with the carcinogen 7,12-dimethylbenzanthracene before use. For this assay, previously prepared aliquots of S-9 which have been deep frozen were thawed and used to prepared the S-9 mix as follows:
S-9 mix contains: S-9 fraction (10% v/v), MgCl2 (8 mM), KCl (33 mM), sodium phosphate buffer pH 7.4 (100 mM), glucose-6-phosphate (5 mM), NADP (4 mM). All the cofactors are filter-sterilized before use. - Test concentrations with justification for top dose:
- Dose range finding test: 5000, 500, 50, 5 µg/plate
Mutation tests: 5000, 1500, 500, 150, 50 µg/plate - Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- buffer or S-9 mix but without solvent or test compound
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-Aminoanthracene (TA 1535. TA 1537), 2-Aminoanthracene (TA 1538, TA 98, TA 100)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- 5 strains per concentration
- 3 individual revertant colony counts per dose level and strain
METHOD OF TREATMENT/ EXPOSURE:
- 0.1 ml overnight bacterial culture containing approximatey 2x10^9 cells/ml
- 0.5 ml S-9-Mix or 0.5 ml 0.1 M sodium phosphate buffer (pH 7.4)
- 0.1 ml test solution
- 2 ml his- agar
- shaken and overlaid onto prepared plates containing 15 ml minimal agar.
TREATMENT AND HARVEST SCHEDULE:
- incubation at 37 °C for 72 h
- After this period plates were examined for the appearance of a complete bacterial lawn. Revertant colonies were counted using a Biotran Automatic Colony Counter. Any toxic effects of the test substance were detected by a substantial reduction in revertant colony counts or by the absence of a complete background bacterial lawn. - Evaluation criteria:
- The mean number of revertant colonies for all treatment groups is compared with those obtained for negative and positive control groups. The effect of metabolic activation is assessed by comparing the results obtained both in the presence and absence of the liver microsomal fraction for each treatment group.
A compound is deemed to provide evidence of mutagenic potential if
(1) a statistically significant dose-related increase in the number of revertant colonies is obtained in two separate experiments, and
(2) the increase in the number of revertant colonies is at least twice the concurrent solvent control value
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- no vast cytotoxicity noted
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- no vast cytotoxicity noted
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- no vast cytotoxicity noted
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- no vast cytotoxicity noted
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- no vast cytotoxicity noted
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with and without metabolic activation
The study is regarded as a valid guideline study with self-reported GLP compliance. The test item did not show mutagenic effects in both experiments. The revertants were not increased in comparison with the spontaneous revertants (solvent only). Therefore it can be stated, that under the test conditions, the test item is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and TA 1538. - Executive summary:
This study was performed in order to evaluate the mutagenic potential of Diaminodiisocyanatozinc.
The study was performed under GLP and conducted in accordance with the following guideline: OECD Guidelines for the Testing of Chemicals „Bacterial Reverse Mutation Test" Part 471, presumed 1981.
In this in vitro assessment of the mutagenic potential of the test item, histidine dependent auxotrophic mutants of Salmonella typhimurium (strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100) were exposed to the test material, diluted in dimethylsulphoxide, which was also used as a negative control.
Two independent mutation tests were performed using agar plates, in the presence and absence of liver preparations from Aroclor 1254 -induced rats.
In the preliminary dose range finding study no toxicity was observed at concentrations of up to 5000 µg/plate. Therefore 5000 µg/plate was chosen as the highest dose level for the subsequent mutation study. Other dose levels used in the mutation assays were: 1500, 500, 150, 50 µg/plate.
The concurrent positive control compounds demonstrated the sensitivity of the assay and the metabolising activity of the metabolic activation system.
No evidence of mutagenic activity was seen at any dose level of the test item in either mutation test.
It is concluded that, when tested at dose levels up to 5000 µg/plate in dimethylsulphoxide, the test item was not mutagenic in either the presence or absence of metabolic activation.
THE TEST ITEM DIAMINODIISOCYANATOZINC CAN BE STATED AS "NOT MUTAGENIC UNDER THE CONDITIONS OF THE TEST".
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