Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-10-3 to 1988-07-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP study according to previous OECD technical guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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:
- - Sample designation: 2,4-Xylidine
- Batch number: 048828-04
- The test substance was contained in three bottles, each containing approx. 1 litre
- One bottle contained a yellow liquid, two a pink liquid. IR spectra revealed no differences
- On the advice of the supplier the contents of the three bottles were mixed for use in this study
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd, Abbots Ripton Road, Wyton, Huntingdon, England
- Age at study initiation: 6-8 weeks
- Weight at study initiation: ca. 200g on day of exposure
- Housing: propylene cages (38cm x 56cm x 18cm) with detachable wire mesh tops and floors, in groups of five (same sex).
- Diet: free access to a measured excess amount of food (Labsure LAD 1)
- Water: free access to a measured excess amount of tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 41-51%
- Photoperiod (hrs dark / hrs light): 12/12hrs
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- clean air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Depending on the concentrations tested a vapour generator (highest dose only) or an aerosol generator (all other doses tested)
- Exposure chamber volume: approx. 120 litres
- Method of holding animals in test chamber: chamber divided by meshpartitions to provide 10 separate animal compartments
- Source and rate of air: supply of clean and fresh air , 25 litres per minute
- Method of conditioning air: in-flow meter was used to monitor air flow throughout the exposure
- System of generating particulates/aerosols: via syringe connected to the generator
- Method of particle size determination: May multistage liquid impringer
TEST ATMOSPHERE
- Brief description of analytical method used: wet-type gasmeter and May liquid multistage impringer
- Samples taken from breathing zone: 5 or 6 samples were taken from the chamber during exposure
- There were no differences in temperature or relative humidity consiered likely to influence the results of the study
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: the results show that on average at least 84% of the test item present in the chamber atmosphere was in the form of vapour or droplets of respirable size, i.e. below 5.5µm aerodynamic diameter - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gas chromatography
- Duration of exposure:
- 4 h
- Concentrations:
- 0.620 (15% variation); 0.549 (10% variation); 1.530 (18% variation); 2.213 (23% variation); 1.695 (48% variation); 1.438 (38% variation) mg/L
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:weighing: daily, clinical observations: continuously during exposure, twice daily during observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights (lung), histopathology (lungs preserved for further histopathological examinations), Food and Water consumption - Statistics:
- Calculation of LC50 according to the log probit method of Miller and Tainter
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1.53 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: std. error. 0.205mg/L
- Mortality:
- table 1
- Clinical signs:
- other: - signs seen were as expected for inhalation of an irritant aerosol/vapour, hence including partial closing of the eyes, a reduced and irregular respiration rate and adoption of hunched body posture - at the higher concentrations a reduced motor activity
- Body weight:
- - all rats that died as a result of exposure lost weight until their death
- suriviving rats had moderate decrease in body weight and body weight gain up to three days following exposure
- water and food consumption were reduced - Gross pathology:
- - rats that died as a result of exposure: congestion of lungs, bladder distension and liver pallor; findings probably due to the long period of unconciousness
- surviving rats: no treatment related effects - Other findings:
- - the lung weight to body weight ratio was increased due to a high lung weight in some rats that died following exposure to the test item
- the lung weights were within normal limits for the control rats and those that survived exposure to the test item
Any other information on results incl. tables
Table 1: Mortality
Group |
Deaths Male |
Deaths Female |
Deaths Total |
Control |
0/5 |
0/5 |
0/10 |
0.620 mg/L |
0/5 |
0/5 |
0/10 |
0.549 mg/L |
0/5 |
0/5 |
0/10 |
1.530 mg/L |
1/5 |
0/5 |
1/10 |
2.213 mg/L |
5/5 |
5/5 |
10/10 |
1.695 mg/L |
5/5 |
5/5 |
10/10 |
1.438 mg/L |
2/5 |
0/5 |
2/10 |
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- From the mortality data of the treated groups the LC50 (4-hour) for 2,4-Xylidine was established at 1.53 mg per litre of air. The standard error of the estimate was 0.205mg/L.
The substance has to be classified as T, R23; H 330 - Fatal if inhaled (Cat. 2). - Executive summary:
The substance has to be classified as T, R23; H 330 - Fatal if inhaled (Cat. 2).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.