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EC number: 408-090-7 | CAS number: 100418-33-5 METHYLGELB
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: mammalian bone marrow chromosome aberration test (migrated information)
Test material
- Reference substance name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- EC Number:
- 408-090-7
- EC Name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- Cas Number:
- 100418-33-5
- Molecular formula:
- C9H12N2O3
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)amino]ethan-1-ol
- Test material form:
- solid: crystalline
- Details on test material:
- red powder
Batch # : 6718 Fass 10/20
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- PEG 400
- Frequency of treatment:
- three consecutive treatments at 24 hours intervals
- Post exposure period:
- 24 hours after the last administration
Doses / concentrationsopen allclose all
- Dose / conc.:
- 187.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 375 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 750 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 40 mg/kg bw cyclophosphamide
Examinations
- Details of tissue and slide preparation:
- Slides were prepared from the bone marrow preparations and stained with May-Grünwald/Giemsa.
- Evaluation criteria:
- At least 2000 PCEs per animal were evaluated for the number of polychromatic erythrocytes (PCE) with micronuclei (without knowledge of the dose group). In addition, the ratio between polychromatic and total erythrocytes per animal was determined. Ten animals per test group (5 males and 5 females) were evaluated as described above.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- only in the highest test dose of 750 mg/kg bw
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Hydroxyethyl-2-nitro-p-toluidine was not mutagenic in the in vivo micronucleus test using NMRI mice after multiple oral administrations up to the maximum tolerated dose of 750 mg/kg bw.
- Executive summary:
Hydroxyethyl-2-nitro-p-toluidine, dissolved in PEG 400, was administered once daily for three consecutive days to groups of six male and six female NMRI mice (supplied by RCC Ltd, Switzerland; 8-10 week old) by gavage of 187.5, 375 and 750 mg/kg bw in a total volume of 10 ml/kg bw. Dose selection was based on findings in the preliminary experiments for toxicity, in which 1000 and 750 mg/kg bw were administered to two female and two male mice each under the same treatment regimen. Treatment with 1000 mg/kg bw lead to excessive toxicity and death in both genders, whereas 750 mg/kg bw was considered to be a suitable high dose for the main experiment. Negative control groups received PEG 400 as described above and concurrent positive control groups received 40 mg/kg bw cyclophosphamide (CPA) dissolved in deionised water once 24 hours before sacrifice. Femoral bone marrow was sampled from mice after sacrifice (24 hours after the last dosing) for all dose groups and the vehicle control. Bone marrow of the concurrent positive control group animals was sampled 24 h after administration of the single dose. Slides were prepared from the bone marrow preparations and stained with May-Grünwald/Giemsa. At least 2000 PCEs per animal were evaluated for the number of polychromatic erythrocytes (PCE) with micronuclei (without knowledge of the dose group). In addition, the ratio between polychromatic and total erythrocytes per animal was determined. Ten animals per test group (5 males and 5 females) were evaluated as described above. The animals of the high dose group were examined for acute toxic symptoms at several time points within the first 24 hours of each administration. Stability and homogeneity data were not provided in the study. However, the dosing-solutions were prepared fresh each day immediately before administration and continuously stirred during the administration. Consequently, it can be assumed that the test item solutions were homogenous and stable for the required single application. In the first preliminary experiment, in which 1000 mg/kg bw was administered three times to 4 animals (2 males and 2 females), one female died within 24 h after the first dose and one male died within 4 hours after the second administration. After this fatality the experiment was terminated and the two remaining animals were humanely killed. At 750 mg/kg bw clear signs of toxicity (apathy, ruffled fur, eyelid closure, abdominal position and reduced spontaneous activity) were noted between 1 and 24 hours after all three administrations, but no cases of death occurred. Therefore 750 mg/kg bw was chosen as the top dose for the main experiment. In the main experiment at the highest test dose of 750 mg/kg bw, the signs of toxicity observed were identical to those of the preliminary experiment. An orange discolouring of the urine was noted within 24 hours after each administration in the high dose group. The ratio of PCEs among total erythrocytes was not affected by the test item at any dose tested. Hence, Hydroxyethyl-2-nitro-p-toluidine showed no clear cytotoxic effect in the bone marrow even if tested at clearly systemically toxic doses with multiple applications. However, the occurrence of discoloured urine together with the occurrence of pronounced systemic toxic effects clearly demonstrates that the substance was systemically distributed and bioavailable. This assumption is further supported by the observations of the subcronic toxicity studies and the results of an in vitro toxicokinetics study, which demonstrated a very good penetration of Hydroxyethyl-2-nitro-p-toluidine through the intestinal barrier. There was no statistically significant or biologically relevant increase in the number of micronuclei per 2000 PCEs in the mice of any of the Hydroxyethyl-2-nitro-p-toluidine treated groups versus the respective vehicle control groups. The positive control group (CPA) produced a clear and significant increase in micronucleated PCEs and the vehicle control was well within the range of historical control data of the performing laboratory. This demonstrates the validity and sensitivity of the test system.
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