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EC number: 202-823-2 | CAS number: 100-15-2
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.02.2008 - 20.03.2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD ) and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-methyl-4-nitroaniline
- EC Number:
- 202-823-2
- EC Name:
- N-methyl-4-nitroaniline
- Cas Number:
- 100-15-2
- Molecular formula:
- C7H8N2O2
- IUPAC Name:
- N-methyl-4-nitroaniline
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): N-methyl-4-nitroaniline
- Physical state: yellow to orange cyristalline powder
- Analytical purity: 99.3 %
- Purity test date: CoA dated 06-Feb-2008
- Lot/batch No.: 304269
- Expiration date of the lot/batch: 30-Nov-2008
- Storage condition of test material: at room temperature, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han), SPF quality
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: Males 188 g to 199 g, females 161 g to 181 g
- Fasting period before study: over night
- Housing: groups of up to three animals and one gender per cage (Noryl, type V).
- Diet (e.g. ad libitum): pelleted dry food ad libitum
- Water (e.g. ad libitum): municipal water ad libitum
- Acclimation period: 28.02.2008: arrival of animals, 04.03.2008: start of administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 2 °C
- Humidity (%): 45 % - 75 %
- Air changes (per hr): approximately of 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % aqueous hydroxyethylcellulose
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg - Doses:
- 300 mg/kg body weight
2000 mg/kg body weight - No. of animals per sex per dose:
- 300 mg/kg: 3 females
2000 mg/kg: 3 females and 3 males - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical observation: at least twice daily, on non-working days once
Body weight: Day before administration, Day 2, Day 8 and Day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,PATHOLOGY
Results and discussion
- Preliminary study:
- In animals at 300 mg/kg, no mortality, no clinical signs or influence on body weight
development were noted during the course of the study. No macroscopic changes were
observed at necropsy.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: ALD
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was noted during the study.
- Clinical signs:
- 300 mg/kg (females)
No clinical signs were noted during the study.
2000 mg/kg (males and females)
In all animals, rough coat, decreased locomotor activity, hunched posture, narrow palpebral
fissure and intensively yellow colored urine were noted on Day 1. These signs were absent by
Day 2 at the latest. Additionally, in females, stilted gait was observed 1 h post administration
on Day 1.
From Day 7/8 (males/females) until the end of the observation period, yellowish stained coat
and tail was noted - Body weight:
- No effects on body weight and body weight development were noted in males and females
during the study. - Gross pathology:
- No macroscopic changes were noted at necropsy in male and female rats.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, a single oral administration of
N-methyl-4-nitroaniline at doses of 300 (females) and 2000 mg/kg (males and females) was
associated with no deaths but distinct signs of toxicity at 2000 mg/kg on the day of dosing.
The approximate lethal dose (ALD) is considered to be above 2000 mg/kg in rats.
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