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EC number: 202-440-0 | CAS number: 95-68-1
- 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:
- supporting study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: None-guideline study following a scientifically sound study design (mechanistic study) with sufficient study reporting.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- no guideline available
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- only males tested, 20 day study
- Principles of method if other than guideline:
- Method as described in Short et al., see reference.
The study was designed to provide a histopathologic evaluation of specific target organs following oral administration of the test substance for either 5, 10 or 20 days. Each rat in the 8 treatment groups and the group of controls were gavaged once daily. Each group contained 30 rats and all groups began treatment on the same day. The materials were administered orally via gavage needle without vehivle at 25 % of the estimated oral LD50. 10 rats out of each group were sacrificed at 5 days (after 5 consecutive doses). Ten more were sacrificed at 10 days, and the final at 10 and 20 days, following continual daily dosing. - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2,4-xylidine
- EC Number:
- 202-440-0
- EC Name:
- 2,4-xylidine
- Cas Number:
- 95-68-1
- Molecular formula:
- C8H11N
- IUPAC Name:
- 2,4-dimethylaniline
- Details on test material:
- Source: Aldrich Chemical Co.
Purity: 98.7 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - nine weeks of age
- 10d acclimation period
- 2 rats per cage
- 12hr light-cycle
- 72°F +/-2°F
- Purina rat chow and water were supplied ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The study was designed to provide a histopathologic evaluation of specific target organs following oral administration of the test substance for either 5, 10 or 20 days. Each rat in the 8 treatment groups and the group of controls were gavaged once daily. Each group contained 30 rats and all groups began treatment on the same day. The materials were administered orally via gavage needle without vehicle at 25 % (117 mg/kg bw/d) of the estimated oral LD50 (467 mg/kg bw). 10 rats out of each group were sacrificed at 5 days (after 5 consecutive doses). Ten more were sacrificed at 10 days, and the final at 10 and 20 days, following continual daily dosing.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5, 10 or 20 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
117mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 30 rats per substance, 10 sacrificed after 5d, 10 sacrificed after 10d and 10 sacrificed after 20d of expousre
- Control animals:
- yes, sham-exposed
- Details on study design:
- please refer to "Details on exposure"
- Positive control:
- no data
Examinations
- Observations and examinations performed and frequency:
- Daily observations of general health, estimates of food and water consumption, and body weights during acclimation and treatemt period
- Sacrifice and pathology:
- - 10 rats at day 5
- 10 rats at day 10
- 10 rats at day 20
- Exsanguination via cardiac puncture after being rendered unconcious in an atmosphere of CO2
- Liver, spleen, thyroid, urinary bladder and kidneys were removed, trimmed of fat, weighed and fixed in neutral buffered 10% formalin, as well as samples of trachea and esophagues
- Bone marrow impressions were made from a cross section of femur
- Histological sections were prepared and stained by hematoxylin and eosin by conventional methods
- Sections of liver, spleen and kidney were also stained with Prussian Blue for confirmation of hemosiderin scoring - Other examinations:
- none
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- thinness and rough hair
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- thinness and rough hair
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- depressed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- severely depressed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- increased kidney and liver weight
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- mild tracheitis
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- - 2 dead rats after 10d of dosing and 1 dead rat after 20d of dosing
- clinical signs comprised: thinness, rough hair coat
- body weight decreased
- spleen to body weight rations were increased, w/o specific changes in spleen weights
- liver weights and liver to body weight ratio was increased
- kidney weights were unchanged, with a slight increase in kidney to body weight ratio
- histopathological lesions: mild tracheitis, probably due to the administration procedure
- slight congestion of the spleen
- slight hemosiderosis in spleen
- toxic hepatopathy with extensive cloudy swelling, diffuse hepatocellular necrosis, early periacinar connective tissue proliferation, biliary hyperplasia, and periacinar vacuolar degeneration
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- < 117 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: changes in body weight and organs
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Rats treated with 2,4 -Dimethylaniline had a toxic hepatopathy characterized by extensive cloudy swelling deffisue hepatocellular necrosis, early periacinar connective tissue proliferation, biliary hyperplasia, and periacinar vacuolar degeneration as described in article. In addition there were secret island of periacinar vacuolar degeneration that appeared as small islands of lipoid cells.
Applicant's summary and conclusion
- Conclusions:
- From the results presented in this publication a NOAEL for 2,4-Dimethylaniline is < 117 mg/kg bw/d based on severe hepatic effects.
- Executive summary:
The study was designed to provide a histopathologic evaluation of specific target organs following oral administration of the test substance for either 5, 10 or 20 days. Each rat in the 8 treatment groups and the group of controls were gavaged once daily. Each group contained 30 rats and all groups began treatment on the same day. The materials were administered orally via gavage needle without vehicle at 25 % (117 mg/kg bw/d) of the estimated oral LD50 (467 mg/kg bw). 10 rats out of each group were sacrificed at 5 days (after 5 consecutive doses). Ten more were sacrificed at 10 days, and the final at 10 and 20 days, following continual daily dosing.
The following effects were observed:
2 dead rats after 10d of dosing and 1 dead rat after 20d of dosing
- clinical signs comprised: thinness, rough hair coat
- body weight decreased
- spleen to body weight rations were increased, w/o specific changes in spleen weights
- liver weights and liver to body weight ratio was increased
- kidney weights were unchanged, with a slight increase in kidney to body weight ratio
- histopathological lesions: mild tracheitis, probably due to the administration procedure
- slight congestion of the spleen
- slight hemosiderosis in spleen
- toxic hepatopathy with extensive cloudy swelling, diffuse hepatocellular necrosis, early periacinar connective tissue proliferation, biliary hyperplasia, and periacinar vacuolar degeneration.
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