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EC number: 246-309-6 | CAS number: 24549-06-2
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic data given, comparable to standards but with limitations concerning dosage and observation parameters compared to the guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Subacute Toxicity of Several Ring-Substituted Dialkyanilines in the Rat.
- Author:
- Short, C.,R; King, C.; Sistrunk, P.; Kriklyn, M.,K
- Year:
- 1 983
- Bibliographic source:
- Fund Appl Toxicol 3: 285-292
Materials and methods
- Principles of method if other than guideline:
- Method: other subacute toxicity study
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 6-ethyl-2-toluidine
- EC Number:
- 246-309-6
- EC Name:
- 6-ethyl-2-toluidine
- Cas Number:
- 24549-06-2
- Molecular formula:
- C9H13N1
- IUPAC Name:
- 2-ethyl-6-methylaniline
- Details on test material:
- IUCLID4 Test substance: other TS: 2-methyl-6-ethylaniline, purity: 98.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Source: Charles River Breeding Laboratories, Wilminton, MA; animals were held for a 10-day acclimatization period after random assignment to test groups; the rats were housed two per cage in stainless steel cages in a room with 12-hour light cycle and 72°F (+/-2°F) temperature; purina rat chow and tap water were provided ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test material was administered orally via gavage needle without vehicle at 25% of the estimated oral LD50.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 5, 10 or 20 d
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
221 mg/kg bw/d
Basis:
- No. of animals per sex per dose:
- 30 rats per dose group; 10 rats were sacrificed at 5 days (after five consecutive doses), 10 rats were sacrificed at 10 days, and the final ten at twenty days, following continual daily dosing
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no
- Positive control:
- Aniline and o-toluidine were included in the study as positive controls for the production of splenic and bone marrow effects
Examinations
- Observations and examinations performed and frequency:
- Body and organ weights (liver, kidney, spleen) were measured at each sacrifice period, i. e., at 5, 10 and 20 days of treatment or sham gavage (controls); clinical signs and mortality: daily
- Sacrifice and pathology:
- Histopathological evaluation of: spleen, bone marrow, liver, esophagus, trachea, thyroid, para-thyroid, urinary bladder and kidney,
histopathological evaluations were conducted using a scoring system which graded the severity of lesions from 0 (no effect) to 4 (severe). - Statistics:
- Analysis of body and organ weight changes (compared to matched concurrent controls) was conducted by analysis of variance and Dunnett's procedure, with differences in means accepted at the p<0.05 level, mean scores for lesions and exposure-related mortality were examined for significant difference from controls using the Fischers Exact Test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- The study was designed to evaluate the subacute toxicity of several industrially important disubstituted anilines on selected tissues: liver, kidney, spleen, bone marrow. o-toluidine was included as positive control for the production of splenic and bone marrow effects.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 221 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: hypercellularity in the bone marrow
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
MORTALITY
- number of death: 0/30
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
---Clinical signs: none
---Body weight: not significant different to concurrent control rats (dose group versus controls):
-after 5 days: 193.3g versus 214.0g
-after 10 days: 221.4g versus 225.4g
-after 20 days: 211.1g versus 232.9g
---Organ weights:
liver, kidney and spleen: not significant different to the concurrent control rats
HISTOPATHOLOGY
---liver, esophagus, trachea, thyroid, para-thyroid, unrinary bladder and spleen: no histopathological lesions
---bone marrow - hypercellularity:
mean scores (TS versus Controls: d5, d10, d10):
0.56, 1.30(sign.*), 0.33 versus 0.0, 0.0, 0.0*significantly different from matched control value by Fishers Exact Test, <=0.05
Applicant's summary and conclusion
- Executive summary:
In a subacute toxicity study male Fischer 344 rats were treated orally via gavage needle with 2-methyl-6-ethylaniline (221 mg/kg and day). The rats were treated for 5, 10 or 20 days. No clinical signs and mortality were seen in the 2-methyl-6-ethylaniline (MEA) treated rats. The body weight of the treated rats was not significant different to the concurrent control rats. No significant differences in organ weights of liver, kidney and spleen were found in the treated rats compared to the control group. In addition no histopathological lesions were found in the liver, esophagus, trachea, thyroid, para-thyroid, urinary bladder, and spleen after MEA treatment, whereas a hypercellularity in the bone marrow was seen after MEA treatment. The effect was significant different from control on day 10, but not on day 20 (Short 1983).
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