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EC number: 226-122-6 | CAS number: 5285-60-9
- 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:
- 13 February 2018 - 20 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Version / remarks:
- November 2000
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4,4'-methylenebis[N-sec-butylaniline]
- EC Number:
- 226-122-6
- EC Name:
- 4,4'-methylenebis[N-sec-butylaniline]
- Cas Number:
- 5285-60-9
- Molecular formula:
- C21H30N2
- IUPAC Name:
- 4,4'-methylenebis[N-sec-butylaniline]
- Test material form:
- liquid
- Details on test material:
- Appearance: Slight yellow liquid
Storage conditions: At room temperature protected from light
Constituent 1
- Specific details on test material used for the study:
- Adjustment was made for specific gravity of the test item.
Specific density: 0.99 g/cm3
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 8-10 weeks old)
- Weight at study initiation: 139 to 187 g.
- Fasting period before study: yes
- Housing: Group housing of 3 animals per cage in labeled polycarbonate Macrolon cages containing sterilized sawdust as bedding material. For psychological/environmental enrichment, animals were provided with paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd).
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 21
- Humidity (%): 26 - 51%
- Air changes (per hr): ten or more
- Photoperiod (hrs dark / hrs light): 12/12
Deviations from the minimum level of daily mean target humidity occurred (lowest value 26%). This study plan deviation is considered not to have affected the integrity of the study because it did not noticeably affect the clinical condition of the animals or the outcome of the study.
IN-LIFE DATES: From: 13 february 2018 to 20 March 2018
Administration / exposure
- Route of administration:
- oral: gavage
- Details on oral exposure:
- GAVAGE METHOD: syringe with a plastic gavage cannula
Frequency: single dosage, on day 1.
MAXIMUM DOSE VOLUME APPLIED:
2000 mg/kg body weight.
- Rationale for the selection of the starting dose: maximum recommended dose according to OECD 423. - Doses:
- 2000 mg/kg body weight
300 mg/kg body weight - No. of animals per sex per dose:
- 2000 mg/kg: 6 (2 groups of three females in a stepwise manner)
300 mg/kg: 6 (2 groups of three females) - Control animals:
- no
- Details on study design:
- The toxicity of the test item was assessed by stepwise treatment of groups of 3 females. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. The first group was treated at a dose level of 2000 mg/kg. Based on the results, three additional groups were dosed at 2000, 300 and 300 mg/kg.
Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter.
Mortality/Viability: Throughout the study, animals were observed for general health/mortality and moribundity twice daily, in the morning and at the end of the working day.
Body weights: Animals were weighed individually on day 1 (predose), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: All moribund animals and animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 2000 mg/kg, all animals were sacrificed for humane reasons between days 8 and 11.
At 300 mg/kg, no mortality occurred. - Clinical signs:
- other: At 2000 mg/kg, in the first dose group, hunched posture and piloerection were noted on day 1 and ventro-lateral recumbency, hunched posture, decreased locomotor activity, piloerection, lean appearance and/or ptosis were noted from day 5 onwards. At 2000 m
- Gross pathology:
- At 2000 mg/kg, abnormalities of the thymus (reduced in size), liver (discolouration, pale) and stomach (irregular surface of the forestomach) and general emaciation were found for the animals that were sacrificed for humane reasons during the study, at macroscopic examination.
At 300 mg/kg abnormalities of the thymus (many tan foci) were noted for one animal. Macroscopic post mortem examination of the other animals did not reveal any abnormalities.
Any other information on results incl. tables
According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In an acute oral toxicity test, the oral LD50 of 4,4’-methylenebis-N-sec-butylaniline was found to be > 300 mg/kg bodyweight and < 2000 mg/kg bodyweight.
- Executive summary:
An acute oral toxicity test was performed according to OECD guideline 423 and GLP principles. Three female Wistar rats were exposed to 2000 mg/kg body weight 4,4’-methylenebis-N-sec-butylaniline. In a stepwise procedure three additional groups of three females were dosed at 2000, 300 and 300 mg/kg body weight. At 2000 mg/kg, in the first dose group, hunched posture and piloerection were noted on day 1 and ventro-lateral recumbency, hunched posture, decreased locomotor activity, piloerection, lean appearance and/or ptosis were noted from day 5 onwards. At 2000 mg/kg, in the second dose group, hunched posture, uncoordinated movements, decreased locomotor activity and/or piloerection were noted from day 1 onwards. At 300 mg/kg, hunched posture, uncoordinated movements and/or piloerection were noted for the animals between days 1 and 2. In addition, quick breathing and chromodacryorrhoea (nose) were noted for one animal on day 1. At 2000 mg/kg, all animals were sacrificed for humane reasons between days 8 and 11. At 300 mg/kg, no mortality occurred. No abnormalities in weight were observed in all dose groups. Necroscopy performed on 2000 mg/kg dose groups showed abnormalities at the thymus (reduced in size), liver (discolouration, pale) and stomach (irregular surface of the forestomach) and general emaciation were found for the animals that were sacrificed for humane reasons during the study, at macroscopic examination. At 300 mg/kg, abnormalities of the thymus (many tan foci) were noted for one animal. Macroscopic post mortem examination of the other animals did not reveal any abnormalities.
Based on these results, the oral LD50 of 4,4’-methylenebis-N-sec-butylaniline was found to be > 300 mg/kg bodyweight and therefore according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments), 4,4’-methylenebis-N-sec-butylaniline should be classified as Category 4 and should be labeled as H302: Harmful if swallowed.
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