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EC number: 245-082-0 | CAS number: 22564-43-8
- 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:
- 1992-01-31 - 1993-06-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- as set out in EEC Directive 84/449/EEC, method B.14
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- as of 1983-05-26
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: New and Revised Health Effects Test Guidelines October 1984. HG - Gene Muta - S. typhimurium
- Version / remarks:
- October 1984
- Deviations:
- not specified
- Principles of method if other than guideline:
- The study was performed according to OECD 471 as adopted in 1983, so only four strains (instead of five strains including S. typhimurium TA 102) were used, which was first foreseen in the revised version of 1997. Consequently, the study does not show any deviations from the guideline as adopted in 1983, but from the most recent guideline.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(2-chloroethyl)-N-ethylaniline
- EC Number:
- 245-082-0
- EC Name:
- N-(2-chloroethyl)-N-ethylaniline
- Cas Number:
- 22564-43-8
- Molecular formula:
- C11H16ClN
- IUPAC Name:
- N-(2-chloroethyl)-N-ethylaniline
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- his-
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: deep rough; reduced ability to repair damage from UV light
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced S9 mix
- Test concentrations with justification for top dose:
- 0, 8, 40, 200, 1000, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol (test item); DMSO (positive controls)
- Justification for choice of solvent/vehicle: The used solvent was selected from a priority list in the order water, methanol, ethanol, acetone, DMSO, DMF and ethylene glycol dimethylether (EGDE).
Controls
- Untreated negative controls:
- yes
- Remarks:
- vehicle
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: nitrofurantoin; 4-nitro-1,2-phenylene diamine, 2-aminoanthracene
- Remarks:
- sodium azide 10 µg/plate (only TA1535), nitrofurantoin 0.2 µg/plate (only TA100), 4-nitro-1,2-phenylene diamine 10 µg/plate (only TA1537) / 0.5 µg/plate (only TA98), 2-aminoanthracene 3 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 30 sec
- Exposure duration: 48 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48 h
SELECTION AGENT (mutation assays): his-negative agar
NUMBER OF REPLICATIONS: 4 plates per strain, dose, ± S9
DETERMINATION OF CYTOTOXICITY
- Method: The toxicity of the substance was assessed in three ways. First background growth on the plates for mutant determination was inspected. If a reduction in background growth was observed, this indication for toxicity was indicated in the tables by the letter "B" after the mutant count. A single "B" without any numerical value for a mutant count represents four plates with reduced background growth at a given concentration. (The same applies to the symbols "C", "V", "P", "N" or "%", which may also appear in the tables.) Secondly, a toxic effect of the substance was assumed when the mutant count per plate was reduced significantly and in a dose-dependent manner as compared to the corresponding negative control. The third criterion was the bacteria titer. Total bacterial counts were taken on two plates with S9 mix for each concentration studied. If a test was performed only without S9 mix, however, the bacterial count was taken on plates without S9 mix. - Evaluation criteria:
- A test is defined as being positive if a reproducible and dose-related increase of mutant colony numbers becomes apparent for at least one strain. For TA 1535, TA 100 and TA 98 mutant colony numbers should increase by a factor of two or more over negative control numbers, while at least a three-fold increase should be apparent for TA 1537. Otherwise, the result is judged as negative. However, these guidelines may be overruled by good scientific judgement. In case of questionable results, investigations should continue, possibly with modifications, until a final evaluation is possible.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: TA 1535 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: TA 1537 and TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY:
There was no indication of a bacteriotoxic effect at doses of up to and including 40 µg per plate. The total bacteria counts consistently produced results in the range of the negative controls, or differed only insignificantly. No growth inhibition was observed. Higher doses revealed a weak bacteriotoxic effect. Nevertheless, doses up to 2000 µg per plate could still be used for assessment purposes.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: positive
Testing for mutagenicity in bacteria was performed according to OECD guideline 471 as adopted 1983-05-26. Although not being conducted to recent guidelines, the test was conducted scientifically reasonable with negligible deficiencies. Also, the testing was sufficiently documented, positive and negative controls gave the appropriate response. Hence, the results can be considered as sufficiently reliable to assess the mutagenic potential of the test substance in bacteria. Due to the sensitivity, clear indication of mutagenic effects for the test substance could be found at assessable doses up to 2000 µg per plate for the two strains TA 1535 and TA 100. In consequence, the test substance is considered to be mutagenic under the conditions of this test. - Executive summary:
In a reverse gene mutation assay in bacteria (OECD 471), histidine-auxotrophic strains TA1535, TA100, TA1537 and TA98 of S. typhimurium were exposed to the test substance in ethanolat concentrations of 0, 8, 40, 200, 1000, 5000 µg/plate in the presence and absence of mammalian metabolic activation (induced S9) via plate co-incubation.
The positive controls induced the appropriate responses in the corresponding strains.
Doses of up to 40 µg of test substance per plate did not induce bacteriotoxic effect in the Salmonella/microsome test: Total bacteria counts remained unchanged and no growth inhibition was observed. the substance revealed weak bacteriotoxic effects at higher doses but doses up to 2000 µg per plate could still be used for assessment purposes.
Evaluation of individual dose groups, with respect to relevant assessment parameters (dose effect, reproducibility), revealed clear, biologically relevant variations from the respective negative controls for TA 1535 and TA 100. These were regarded as mutagenic effects of the test substance. Since the lowest reproducible effective dose was in the low dose range, and a mutagenic effect was noted both in Salmonella typhimurium TA 1535 and TA 100, the Salmonella/microsome test showed the test substance to be a strong and definite mutagen.
In spite of the low doses used, positive controls increased the mutant counts significantly over negative control levels which demonstrated the system's high sensitivity.
Due to the sensitivity, clear indication of mutagenic effects for the test substance could be found at assessable doses up to 2000 µg per plate for the two strains TA 1535 and TA 100.
This study is classified as acceptable; it satisfies the requirement for Test Guideline OECD 471 (as adopted 1983-05-26) for in vitro mutagenicity (bacterial reverse gene mutation) data with minor deviations from the recent Guideline. According to REACH Annex VII column 2, further mutagenicity studies shall be considered in case of a positive result. However, further tests can be omitted as "de-risking" in mammalian cells / in vivo is not necessary, because the substance is only registered as an intermediate under strictly controlled conditions, where exposure is controlled anyway.
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