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EC number: 236-882-0 | CAS number: 13531-52-7
- 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-10-18 - 1990-12-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment; only four strains were tested.
- Justification for type of information:
- Corresponding to the draft decision (CCH-D-2114618994-36-01/D) the registrant agrees to conduct an OECD 471.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- , only four strains
- 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
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix prepared from sprange Dawlay rat livers after Aroclor 1254 activation
- Test concentrations with justification for top dose:
- 0, 20 ,100, 500, 2500, 5000 µg/plate (TA 100, TA 1537, TA 98; SPT)
0, 500, 1000, 5000, 7000 µg/plate (TA 1535; SPT)
0, 4, 20, 100, 500, 2500 µg/plate (all tester strains; PIT) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see details
- Details on test system and experimental conditions:
- Standard plate test
Test tubes containing 2 ml portions of saft agar kept in a water bath at 45°C, and the remaining companents are added in the following order:
0.1 mL test solution
0.1 mL bacterial suspension
0.5 mL S-9 mix (in tests with metabolic activatian) or
0.5 mL phosphate buffer (in tests without metabalic activatian)
After mixing, the samples are poured onto Vogel-Bonner agar plates. After incubation at 37°C for 48 -72 hours in the dark, the bacterial calonies (his+ revertants) are counted.
Preincubation test
0.1 mL test solution or vehicle, 0.1 ml bacterial Suspension and 0.5 mL S-9 mix are incubated at 37°C for the duration of 20 minutes. Subsequently, 2 ml of soft agar is added and, after mixing, the samples are poured onto the agar plates within approx.30 seconds.
Both Tests
In each experiment 3 Test plates per dose per control used. After incubation at 37°C for 48 hours in the dark, the bacterial colonies (his+ revertants) are counted.
Posivite Control:
with S-9 mix:
10 µg 2-aminoanthracene (2-AA) (dissolved in DMSO) for the strains TA 100, TA 98, TA 1537and TA 1535
without S-9 mix:
5 µg N-methyl-N'-nitro-N-nitroso-guanidine (MNNG) (dissolved in DMSO) for the strains TA 100 and TA 1535
10 µg 4-nitro-o-phenylendiamine (NOPD) (dissolved in DMSO) for the strain TA 98
100 µg 9-aminoacridine (AAC) chloride monohydrate (dissolved in DMSO) for the strain TA 1537
The Titer was determined and in regularly measurements the strain characteristics were checked. Sterility control performed. - Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test hat to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Toxicity: A bacteriotoxic effect was observed in the standard plate test with and without S-9 mix at 5000 µg/plate.
In the preincubation assay bacteriotoxicity was found only without metabolic activation at 2500 µg/plate.
Mutagenicity: An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
According to the results of the present study, the test substance is not mutagenic in the Ames test under the experimental conditions chosen here. The slightly enhanced figures in the 1st experiment using TA 1535, which might partly be explained by the very 1ow spontaneous rate was not confirmed in two additional standard plate tests and in a preincubation assay. Therefore, these finding are regarded as incidental and not as an indication of a point mutagenic activity.
The positive controls (+S9-mix: 2AA; -S9-mix: MNNG, NOPD, AAC) showed the expected results. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Reference
Results in detail (Ames-test, BASF 1990, Project No. 40M0228/894480)
Plate incorporation with S-9 mix (colony number = mean values) - experiment 1:
Dose (µg/per plate) | TA 100 | TA 1537 | TA 98 | TA1535 |
0 (aqua dest.) | 106 | 11 | 33 | 11 |
20 | 95 | 8 | 34 | 10 |
100 | 96 | 9 | 35 | 13 |
500 | 65 | 11 | 32 | 15 |
2500 | 72 | 9 | 28 | 26 |
5000 | 61 | 12 | 21 | 29 |
10 µg 2-AA | 1563 | 163 | 1507 | 305 |
Plate incorporation without S-9 mix (colony number = mean values) - experiment 1:
Dose (µg/per plate) | TA 100 | TA 1537 | TA 98 | TA 1535 |
0 (aqua dest.) | 99 | 6 | 22 | 18 |
20 | 107 | 6 | 22 | 27 |
100 | 112 | 7 | 19 | 25 |
500 | 108 | 8 | 26 | 24 |
2500 | 95 | 8 | 18 | 23 |
5000 | 83 | 9 | - | 21 |
5 µg MNNG | 1500 | 1465 | ||
100 µg AAC | 539 | |||
10 µg NPD | 808 |
Plate incorporation with S-9 mix (colony number = mean values) - experiment 2:
Dose (µg/per plate) | TA 1535 |
0 (aqua dest.) | 18 |
500 | 23 |
1000 | 22 |
3000 | 21 |
5000 | 24 |
7000 | 19 |
10 µg AA | 195 |
Plate incorporation without S-9 mix (colony number = mean value) - experiment 2:
Dose (µg/per plate) | TA 1535 |
0 (aqua dest.) | 18 |
500 | 27 |
1000 | 25 |
3000 | 24 |
5000 | 23 |
7000 | 21 |
5 µg MNNG | 1465 |
Plate incorporation with S-9 mix (colony number = mean value) - experiment 3:
Dose (µg/per plate) | TA 100 | TA 1537 | TA 98 | TA1535 |
0 (aqua dest.) | 117 | 15 | 42 | 18 |
4 | 106 | 12 | 45 | 10 |
20 | 120 | 11 | 35 | 12 |
100 | 132 | 11 | 32 | 9 |
500 | 122 | 15 | 24 | 18 |
2500 | 101 | 10 | 21 | 25 |
10 µg 2-AA | 1061 | 96 | 687 | 187 |
Plate incorporation with S-9 mix (colony number = mean value) - experiment 3:
Dose (µg/per plate) | TA 100 | TA 1537 | TA 98 | TA1535 |
0 (aqua dest.) | 105 | 12 | 21 | 23 |
4 | 105 | 12 | 14 | 18 |
20 | 120 | 8 | 21 | 19 |
100 | 135 | 12 | 22 | 19 |
500 | 111 | 13 | 21 | 20 |
2500 | - | 2 | 7 | 9 |
5 µg MMNG | 981 | 1010 | ||
100 µg AAC | 479 | |||
10 µg NPD | 740 |
Plate incorporation with S-9 mix (colony number = mean values) - experiment 4:
Dose (µg/per plate) | TA 1535 |
0 (aqua dest.) | 16 |
500 | 17 |
1000 | 19 |
3000 | 24 |
5000 | 19 |
7000 | 18 |
10 µg AA | 151 |
Plate incorporation without S-9 mix (colony number = mean value) - experiment 4:
Dose (µg/per plate) | TA 1535 |
0 (aqua dest.) | 14 |
500 | 16 |
1000 | 19 |
3000 | 19 |
5000 | 16 |
7000 | 10 |
5 µg MNNG | 1777 |
- : reduced his- background
2-AA: 2-Aminoanthracene (dissolved in DMSO)
MNNG: N-Methyl-N'-nitro-N-nitrosoguanidine (dissolved in DMSO)
AAC: 9-aminoacridine chloride monohydrate (dissolved in DMSO)
NPD: 4-nitro-o-phenylendiamine (dissolved in DMSO)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
in vitro:
Bacterial gene mutation, target substance (BASF, 1990)
Toxicity: A bacteriotoxic effect was observed in the standard plate test with and without S-9 mix at 5000 µg/plate. In the preincubation assay bacteriotoxicity was found only without metabolic activation at 2500 µg/plate.
Mutagenicity: An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
According to the results of the present study, the target substance is not mutagenic in the Ames test under the experimental conditions chosen here.
The slightly enhanced figures in the 1st experiment using TA 1535, which might partly be explained by the very low spontaneous rate was not confirmed in two additional standard plate tests and in a preincubation assay. Therefore, these finding are regarded as incidental and not as an indication of a point mutagenic activity.
The positive controls (+S9-mix: 2AA; -S9-mix: MNNG, NOPD, AAC) showed the expected results.
Bacterial gene mutation, source substance N3/N4-Amine (BASF, 1997)
Toxicity: A bacteriotoxic effect was observed at doses >= 2,500 µg/plate.
Mutagenicity: An increase in the number of his+ revertants or trp+ was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
According to the results of the present study, the source substance (N3/N4-Amine) is not mutagenic in the Ames test and in the Escherichia coli reverse mutation assay under the experimental conditions chosen here.
Chromosome aberration assay, source substance N3/N4-Amine (BASF, 1997)
In both independent experiments, neither biologically relevant nor statistically significant increases in cells with structural aberrations were observed after treatment with the source substance. In both experiments, no biologically relevant increase in the frequencies of polyploidy metaphases was found after treatment with the source substance (N3/N4-Amine) as compared to the frequencies of the solvent controls. Appropriate mutagens were used as positive controls and showed the expected results.
HPRT Test, source substance N3/N4-Amine (BASF, 1997)
The assay was performed in two independent experiments, using identical procedures, both with and without rat liver microsomal activation.
No precipitation of the source substance occurred up to the maximal concentration neither in the presence nor in the absence of metabolic activation. In the absence of metabolic activation strong toxic effects occurred starting at concentrations of 1000 µg/mL in the first and 2000 µg/mL in the second experiment. In the presence of metabolic activation toxic effects were observed beginning at 3000 µg/mL in the first and at 4000 µg/mL in the second experiment.
No biologically relevant increase in mutant colony numbers was observed in both independent experiments up to the maximal concentration of the source substance neither in the presence nor in the absence of metabolic activation. Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies.
Bacterial gene mutation, source substance N4-Amine (BASF, 2012)
Toxicity: A weakly bacteriotoxic effect was observed only in the preincubation test depending on the test conditions at doses > 2500 µg/plate.
Mutagenicity: An increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
According to the results of the present study, the source substance is not mutagenic in the Ames test under the experimental conditions chosen here. (This result is supported by a previous peformed study with N4 -amine which is listed for the sake of completeness (BASF, 1990)).
in vivo:
Disregarded study with RA substance due to methological deficiencies.
Justification for selection of genetic toxicity endpoint
Only one study available with the test substance. Estimated Klimisch Rating: 2
Conclusion is supported by read-across approach to two other source substances.
Justification for classification or non-classification
Based on the results of the in vitro genetic toxicity study (Ames test), it is concluded that the target test substance has not to be classified:
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation EC (No) 1272/2008. Based on the available study it is concluded that the target test substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008 , as amended for the sixth time in Regulation (EC) No 605/2014.
This justification is supported by the results of the in vitro studies of two source substances (read-across approach).
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