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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 202-918-9 | CAS number: 101-14-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 - 28 March, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No deviations reported. The study fully meets the current guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Details on test material:
- - Name of test material (as cited in study report): 4, 4'-methylene bis (2-chlorobenzen amine)
- Substance type: white, needlelike crystalline powder
- Physical state: solid
- Analytical purity: 99.76%
- Impurities (identity and concentrations): not mentioned
- Purity test date: 2002-12-12
- Lot/batch No.: FG-3002
- Expiration date of the lot/batch: not mentioned
- Stability under test conditions: stable during study period; purity was 99.11 % at 2003-12-15
- Storage condition of test material: protected from air and moisture at 1-7 °C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan
- Age at study initiation: 7 weeks
- Weight at study initiation: 212 - 282 g
- Fasting period before study: 16 hours before dosing
- Housing: individually in wire-mesh steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 ml/ kg bw
- Justification for choice of vehicle: not mentioned
- Lot/batch no. (if required): 2925
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no information available for lethal dose in rats. Starting dose 300 mg/kg according to guideline. - Doses:
- 300, 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently up to 6 hours, thereafter once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- 1) Lethal dose: Approximate lethal doses were estimated based on the numbers of dead animals of each dose level.
2) Body weight: Mean and standard deviations of body weights were calculated for each administration date. The standard deviations were not calculated when the numbers of animals were not more than two.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- 2 000 mg/kg bw
- Mortality:
- After 6 rats were administered 300 or 2000 mg/kg (3 rats for each dose), one rat at 2000 mg/kg died. The lethal dose was estimated as 2000 mg/kg.
- Clinical signs:
- other: At the first dose of 300 mg/kg, no abnormal clinical signs were observed. At the second dose of 300 mg/kg, dark red discoloration of ear auricles and limbs were observed in one out of three rats the day after administration, which resolved 2 days after ad
- Gross pathology:
- In the dead animal, unkempt fur, white foci in the liver, dark red adrenal glands (bilateral), dark red foci of the proventriculus and glandular stomach, and dark red contents in the small intestine from jejunum to ileum were observed. No abnormal gross findings were noted in the body surface, organs or tissues of the head, chest and abdomen in the surviving animals
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In a study with 6 female rats an acute oral LD50 of 2000 mg/kg bw was estimated. The study was conducted conform OECD guideline 423 under GLP-conditions.
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.
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