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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: in compliance with the guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
- Principles of method if other than guideline:
- Method: other: acute inhalation toxicity study (5 rats/sex/conc., 4 hrs, aerosol exposure, whole-body inhalation, 14-day observation period with subsequent necropsy)
- GLP compliance:
- yes
- Test type:
- other: Acute inhalation toxicity study
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-ethylanilin, purity: 99.45 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory, Portage, MI
- Age at study initiation: ca 9- 10 weeks
- Weight at study initiation: males: ca. 323 g, females ca. 203 g
- Housing : individual suspended stainless steel mesh cages, over paper bedding
- Diet: ad libitum, except during exposure
- Water: ad libitum, except during exposure
- Acclimation period: 10 d
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 64 to 79 °F
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 h
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: a 300 liter New York University-style stainless steel chamber with a pyramidal top and bottom
- Exposure chamber volume: 300 liter New York University-style
- Method of holding animals in test chamber: individual stainless steel wire mesh cages, positioned in two tiers in the chamber
- Method of particle size determination: analysis performed with an Anders cascade inpactor - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- 4 per exposure at approx. one-hour intervals
- Duration of exposure:
- 4 h
- Concentrations:
- 2.1, 2.5, 3.2 mg/l in air
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: during exposure observations: approx. hourly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- LC50 males: calculated by Binomial method, LC 50 females and combined LC50: calculated by Probit method
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 2.6 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- group 2.1 mg/l: males 0/5, females 2/5; group 2.5 mg/l: males: 0/5, females 4/5; group 3.2 mg/l: males 3/5, females 5/5
- Clinical signs:
- other: Signs of intoxication: --during exposure: hypoactivity and clear nasal discharge --immediately after exposure: nonresponsive, disuse of limbs, labored respiration, clear nasal discharge, salivation --post-exposure day 1-4: nonresponsive, prostrate, d
- Body weight:
- weight loss in all animals by post-exposure day 2, by post-exposure day 14 all animals were gained weight and exceeded their pre-exposure weights
- Gross pathology:
- Gross necropsy findings noted in unscheduled deaths were corneal opacity, abnormal discharge/encrustation about eyes, abnormal liver color, fecal stained skin, abnormal color of testis, and abnormal contents (green fluid) of urinary bladder. The only necropsy findings noted at the scheduled sacrifices were corneal opacity and hydronephrosis. Hydronephrosis, however is relatively common in animals of this strain and age and was not considered test-related.
Any other information on results incl. tables
RS-Freetext:
LC50 (male): 3.1 mg/l
LC50 (female): 2.2 mg/l
LC50 (combined 2.6 mg/l
Mortality
occurred from the first day post exposure:
2.1 mg/l-gr.: 0/5 males, 2/5 females
2.5 mg/l-gr.: 0/5 males, 4/5 females
3.2 mg/l-gr.: 3/5 males, 5/5 females
Signs of intoxication:
--during exposure: hypoactivity and clear nasal discharge
--immediately after exposure:
nonresponsive, disuse of lims, labored respiration, clear nasal discharge, salivation
--post-exposure day 1-4:
nonresponsive, prostrate, disuse of limbs, labored respiration, slow respiration, rattling sounds, red/brown perinasal encrustation, purulent ocular discharge, lacrimation, ocular opacity, periocular encrustation
--post-exposure day 5-14:
ocular opacity
mean Particle size(Mass Median Aerodynamic Diameter):
2.1 mg/l: 3.9 micrometer
2.5 mg/l: 3.9 micrometer
3.2 mg/l: 3.6 micrometer
Applicant's summary and conclusion
- Executive summary:
In an acute inhalation study (Bechtel 1989) three groups of 5 male and 5 female Sprague-Dawley rats were each exposed for 4 hours to an atmosphere of aerosolized 2-methyl-6-ethylaniline at mean analytical concentrations of 2.1, 2.5, or 3.2 mg per liter in air (whole body exposure). Exposure was followed by a 14-day observation period and subsequent necropsy. At the highest exposure concentration eight rats died, at the 2.5 mg/l level four animals dies and at the 2.1 mg/l level two animals died. The calculated LC50 values for both sexes were 2.6 mg/l, for females 2.2 mg/l. and for the males 3.1 mg/l. The observations during exposure showed a visible hypo-activity of the animals and clear nasal discharge. The clinical signs noted immediately after exposure were non-responsiveness, disuse of limbs, labored respiration, clear nasal discharge, and salivation. The observations made during post-exposure day one and four showed non-responsiveness, prostrate, disuse of limbs, respiration difficulties, and ocular opacity. From post-exposure days 5 to 14 the only clinical sign noted was ocular opacity. There was weight loss in all animals by post-exposure day 2. By post-exposure day 14 all animals were gained weight and exceeded their pre-exposure weights. Gross necropsy findings noted in unscheduled deaths were corneal opacity, abnormal discharge/encrustation about eyes, abnormal liver color, fecal stained skin, abnormal color of testis, abnormal contents of urinary bladder. The only necropsy findings noted at the scheduled sacrifices were corneal opacity and hydronephrosis, which is relative common in animals of this strain and age and was not considered test-related. The LC50 for both sexes for 2-methyl-6-ethylaniline as administered in this study is 2.6 mg/l in air.
The LC50 for 2-methyl-6-ethylaniline as administered in this study is 2.6 mg/l/ 4 h in air. According to the findings of this study MEA should be classified as harmful by inhalation.
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