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EC number: 222-001-7 | CAS number: 3312-60-5
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test compound was evaluated in an Ames test with and without metabolic activation (Abbott Labs, 1978) and did not demonstrate mutagenic activity in any of the assays conducted in the evaluation and was considered as not mutagenic under the test conditions.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Ames test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977-12-02 to 1978-01-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Sample A-5297 for strain TA-1535 was retested at varous concentrations (see table) in May 1978
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- Salmonella typhimurium TA-1538 and Saccharomyces cerevisiae: D4 was also tested
- Metabolic activation:
- with and without
- Metabolic activation system:
- Reaction mixture containing TPN, G6P, Sodium phosphate, MgCl2, KCL and homogenate fraction
S9 Homogenate - Test concentrations with justification for top dose:
- The compound was tested over a series of concentrations such that there was either quantitative or qualitative evidence of some chemically-induced physiological effects at the high dose level. The dose range employed for the evaluation of this compound was from 0.001 µl to 5 µl per plate.
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 2-nitrofluorene
- other: Methylnitrosoguanidine (MNNG) in Water or Saline, non-activated; Quinacrine mustard (QM) in Water or Saline, non-activated; 2-Anthramine (ANTH) in DMSO, activated; 8-Aminoquinoline (AMQ) in DMSO, activated
- Details on test system and experimental conditions:
- -Plate- Test (Overlay Method)
Approximately 10^8 cells from an overnight culture of each indicator strain were added to separate test tubes containing 2.0 mL of molten agar supplemented with biotin and a trace of histidine. For nonactivation tests, at least four dose levels of the test compound were added to the contents of the appropriate tubes and poured over the surfaces of selective agar plates. In activation tests, a minimum of four different concentrations 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 hours at 37C, and scored for the number of colonies growing on each plate. The concentrations of all chemicals are given in the Results Section. Positive and solvent controls using both directly active positive chemicals and those that require metabolic activation were run with each assay.
- Recording -and Presenting -Data
The numbers of colonies on each plate were counted and recorded on printed forms. These raw data were analyzed in a computer program and reported on a printout. The results are presented
as revertants per plate for each indicator strain employed in the assay. The positive and the solvent controls are provided as reference points. Other relevant data are provided on the computer printout - Evaluation criteria:
- Because the procedures used to evaluate the mutagenicity of the test chemical are semi quantitative, 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:
Strains TA-1535, 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-100, -and- D4
If the solvent control value i s within the normal range, a chemical that produces a positive dose response over three
concentrations with the highest increase equal to twice the solvent control value for TA-100 and two to three times the
solvent control value for strains TA-98 and 04 is considered to be mutagenic. For these strains , the dose response
increase should start at approximately the solvent control value.
Pattern
Because TA-1535 and TA-100 were both derived from the same parental strain (G-46) and because TA-1538 and TA-98 were
both derived from the same parental strain (D3052), there is a built-in redundancy in the microbial assay. In general
the two strains of a set respond to the same mutagen and such a pattern is sought. It is also anticipated that if a
nonactivation tests it will generally do so in activation tests. While similar response patterns are not required for all mutagens, they can be used to enhance the reliability of an evaluation decision.
Reproducibility
If a chemical produces a response in a single test that cannot be reproduced in one or more additional runs, the
initial positive test data loses significance. The preceding criteria are not absolute and other extenuating
factors may enter into a final evaluation decision. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- 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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- Saccharomyces cerevisiae
- Remarks:
- D4
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- The data for strain TA-1535 was judged to be equivocal and therefore was re-tested at Litton Bionetics. The results were clearly negative for genotoxicity (see table).
- Conclusions:
- The test compound did not demonstrate mutagenic activity in any of the assays conducted in the evaluation and was considered as not mutagenic under the test conditions.
- Executive summary:
The compound was tested in an Ames test in six different strains with and without activation incl. positive and negative control. in summary, the test compound did not demonstrate mutagenic activity in any of the assays conducted in the evaluation and was considered as not mutagenic under the test conditions.
Reference
Results of the re-test of strain TA-1535
Concentration | Revertants per plate, nonactivation test | Revertants per plate, activation test |
Solvent control | 26 | 30 |
Positive control | 940 | 285 |
0.001 | 25 | 27 |
0.01 | 33 | 35 |
0.1 | 31 | 35 |
1.0 | 35 | 29 |
5.0 | 36 | 35 |
10.0 | 0 | 9 |
20.0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The test compound was evaluated in an Ames test (Abbott Labs, 1978) and according to criteria of CLP regulation 1272/2008 was considered as not mutagenic under the test conditions.
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