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EC number: 944-584-3 | CAS number: -
- 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
Non mutagenic
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- October 02, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 rat liver fraction
- Test concentrations with justification for top dose:
- 0.2, 2, 20, 200 and 2000 µg (or nl) per Petri dish
- Vehicle / solvent:
- Sterile water
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-anthramine
- Remarks:
- with S9 mix
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- other: daunomycine, N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- Without S9 mix
- Details on test system and experimental conditions:
- REPLICATES: 3
CHECKING OUT TESTER STRAINS
All strains were tested for the presence of their mutations.
a) The mutation in the histidine operon, basic to the test system was tested by checking for growth in the presence and absence of histidine on a minimal medium-agar base.
Bacteria of the nutrient agar plate were streaked on a minimal medium plate supplemented with 0.1 ml of 0.1 mM L-histidine and 0.1 ml of 0.5 mM biotin as a growth requirement.
The plates were incubated at 37 °C overnight. Growth, for all strains, was seen only where histidine and biotin were present.
b) Sensitivity to crystal violet is a check for the presence of the deep rough (rfa) mutation, the loss of the lipopolysaccharide coat on the bacterial surface.
Three drops of the broth culture were spread on the surface of a nutrient agar plate. A sterile filter paper disc containing crystal violet (10 µl of a I mg/ml solution) was placed on this surface. A zone of inhibition around the disc, after 24 hours incubation, shows the presence of the (rfa) mutation.
c) Two of the tested strains (TA 98 and TA 100) contain a plasmid expressing resistance to ampicillin (R factor). To check for the presence of the plasmid, a sterile filter paper disc containing Ampicillin (10 µl of 8 mg/ml in 0.02 N NaOH) was placed on a nutrient agar plate spread with the broth.
In strains TA 1535 and TA 1537 a zone of inhibition occurs around the disc, but for TA 98 and TA 100 where the R factor is present, no zone of inhibition is seen.
d) The uvrB deletion, the loss of the excision repair system, makes the bacteria sensitive to UV irradiation.
One drop of the broth was cross-streaked in a nutrient agar plate. One half of the plate was irradiated for 20 seconds under a 15 watt UV lamp at a distance of approximately 30 cm. After 24 hours' incubation, growth was found only on the unirradiated part of the streak for all strains. - Species / strain:
- other: TA I535, TA I537, TA 98 and TA lOO
- 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
- Positive controls validity:
- not specified
- Conclusions:
- Non mutagenic
- Executive summary:
Method
The substance was tested with the Salmonella typhimurium strains TA I535, TA I537, TA 98 and TA 100 at concentrations from 0.2 to 2000 µg per Petri dish both in the presence and absence of metabolic activation, according to a method similar to the OECD Guideline 471.
Results
No mutagenic effect was observed.
Reference
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
GERM CELL MUTAGENICITY
This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.
Category 1: Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans. Substances known to induce heritable mutations in the germ cells of humans.
Categoty 2: Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.
Classification for heritable effects in human germ cells is made on the basis of well conducted, sufficiently validated tests as In vitro mutagenicity tests such as these indicated in 3.5.2.3.8:
- in vitro mammalian chromosome aberration test;
- in vitro mammalian cell gene mutation test;
- bacterial reverse mutation tests
The substance did not create gene mutations in the strains of Salmonella typhimurium under the performed test, therefore according to the 3.5. of the CLP Regulation EC n.1272/2008, it cannot be classified as mutagenic for germ cells.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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