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EC number: 237-185-4 | CAS number: 13680-35-8
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October - November 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4'-methylenebis[2,6-diethylaniline]
- EC Number:
- 237-185-4
- EC Name:
- 4,4'-methylenebis[2,6-diethylaniline]
- Cas Number:
- 13680-35-8
- Molecular formula:
- C21H30N2
- IUPAC Name:
- 4,4'-methylenebis(2,6-diethylaniline)
- Test material form:
- solid: crystalline
- Details on test material:
- - Physical state: see above
- Appearance: see above
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL
- Substance identification/name in the report: LZ 596
- Molecular formula: C21H30N2
- Batch no.: 1229
- Analysis date: August 12, 2014
- Date of production: August 11, 2014
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage conditions: Controlled room temperature (15-25ºC, <70 RH%), protected from light and humidity.
- Stability under test conditions: stable for min. 3 years from manufacturing date
- Expiry date: August 10, 2017
- Safety precautions: Routine safety precautions (lab coat, gloves, safety glasses, face mask) for unknown materials were applied to assure personnel health and safety.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species / Strain: Crl:(WI)BR rats
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Hygienic level: SPF at arrival and kept in a good conventional environment during the study
- Number of animals: preliminary study 2 female animals/dose / main study: 5 animals/dose
- Age of animals: Young adult rats, females were nulliparous and nonpregnant
- Housing: single housing (main study)
- Sex: female and male
- Body weight range: in preliminary study at starting: 252 - 285 g / in main study at starting: males 239 - 248 g / females 254 - 287 g
- Feeding: ssniff® SM R/M-Z+H complete diet for rats and mice produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany
- Water supply: tap water from municipal source
- Acclimatization time: in preliminary study: 47 days / in main study: 61 days in females and 5 days in malesTEST ANIMALS
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes: 10-15 air exchanges/hour by central air-condition system
- Photoperiod (hrs dark / hrs light): Artificial light, from 6 a.m. to 6 p.m.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- The test substance was moistened sufficiently with water to ensure good contact with the skin.
- Details on dermal exposure:
- The back of animals was shaven (approximately 10 % area of the total body surface) 24 hours prior to the treatment. The test item was applied in a single 2000 mg/kg bw dose uniformly over the shaved skin throughout a 24-hour exposure period. Sterile gauze pads were placed on the skin of rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped with semi
occlusive plastic wrap for 24 hours. At the end of the 24-hour exposure period any residual test item was removed using body temperature water - Duration of exposure:
- 24 hours
- Doses:
- - Preliminary test: 5, 50, 300, 2000 mg/kg
- Main test: 2000 mg/kg - No. of animals per sex per dose:
- - Preliminary test: 2 females/dose
- Main test: 5 males and 5 females - Control animals:
- no
- Details on study design:
- OBSERVATION:
A single administration was performed by dermal route and was followed by a 7-day observation period in preliminary study and 14-day observation period in main study.
MORTALITY:
Inspection for signs of morbidity and mortality were made twice daily at the beginning and end of the working day.
CLINICAL OBSERVATIONS:
Careful clinical observation was made at the following intervals: 1h, 5h after the treatment and once each day for 7 days thereafter in preliminary study and for 14 days thereafter in main study. Individual observations included the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern as well. Particular attention was directed to the observation of tremors,
convulsions, salivation, diarrhoea, lethargy, sleep and coma.
BODY WEIGHTS:
The body weight was recorded on day 0 (shortly before the treatment) in preliminary study and on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g in main study.
PATHOLOGY:
At the end of the observation period all rats of main study were sacrificed under isofluran anaesthesia. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed, and any abnormality was recorded with details of its location, colour, shape and size. Animals of preliminary study were humanely sacrificed on Day 7. - Statistics:
- no statistics perfomed
Results and discussion
- Preliminary study:
- There were no deaths at 5, 50, 300 and 2000 mg/kg bw dose levels. Therefore, in the main test animals were administered the limit dose of 2000 mg/kg bw.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality were observed over a 14-day period following a 24-hour dermal exposure to the test item in male and female rats.
- Clinical signs:
- other: No behavioural changes, symptoms of dermal irritation and corrosion or signs of systemic toxity were noted during the study.
- Gross pathology:
- All animals survived until the scheduled necropsy on Day 15. Pale coloured kidneys as an internal necropsy finding were found in one male.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the acute dermal LD50 value of the test item proved to be greater than 2000 mg/kg bw in male and female WISTAR rats.
- Executive summary:
An acute dermal toxicity study was performed with the test item in Crl:(WI)BR rats, in accordance with testing methods EC B.3 and OECD 402. A limit test was carried out. Single groups of male and female animals (n=5 animals/sex) were exposed to the test item at 2000 mg/kg bw by dermal route. The test item was applied in original form and left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no signs of systemic toxicity were observed during the study. No signs of irritation and corrosion were noted. The body weight development was undisturbed in male animals and slight body weight loss was observed in two females on first week, but it could not be evaluated as a toxic effect of test item. No macroscopic alterations of organs referred to the systemic toxic effect of the test item were seen during necropsy.
Under the experimental conditions the acute dermal LD50 value of the test item LZ 596 proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.
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