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Diss Factsheets
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EC number: 500-268-3 | CAS number: 87041-44-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-[(2-aminocyclohexyl)amino]-3-{4-[2-(4-{3-[(2-aminocyclohexyl)amino]-2-hydroxypropoxy}phenyl)propan-2-yl]phenoxy}propan-2-ol
- Molecular formula:
- C33H52N4O4
- IUPAC Name:
- 1-[(2-aminocyclohexyl)amino]-3-{4-[2-(4-{3-[(2-aminocyclohexyl)amino]-2-hydroxypropoxy}phenyl)propan-2-yl]phenoxy}propan-2-ol
- Reference substance name:
- 1-[(2-aminocyclohexyl)amino]-3-(4-{2-[4-(3-{4-[2-(4-{3-[(2-aminocyclohexyl)amino]-2-hydroxypropoxy}phenyl)propan-2-yl]phenoxy}-2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)propan-2-ol
- Molecular formula:
- C51H72N4O7
- IUPAC Name:
- 1-[(2-aminocyclohexyl)amino]-3-(4-{2-[4-(3-{4-[2-(4-{3-[(2-aminocyclohexyl)amino]-2-hydroxypropoxy}phenyl)propan-2-yl]phenoxy}-2-hydroxypropoxy)phenyl]propan-2-yl}phenoxy)propan-2-ol
- Reference substance name:
- Cyclohex-1,2-ylenediamine
- EC Number:
- 211-776-7
- EC Name:
- Cyclohex-1,2-ylenediamine
- Cas Number:
- 694-83-7
- Molecular formula:
- C6H14N2
- IUPAC Name:
- cyclohexane-1,2-diamine
- Reference substance name:
- unknown
- Molecular formula:
- unknown
- IUPAC Name:
- unknown
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals were received from Charles River (Stone Ridge, NY, and Raleigh, NC), on 13 Apr 2017,
09 May 2017, and 16 May 2017. Following an acclimation period of at least five days, six healthy,
non-pregnant and nulliparous female and three male Sprague Dawley rats were assigned to treatment
groups without conscious bias.
The female animals were born on 15 Feb 2017, 13 Mar 2017, and 20 Mar 2017, and the male animals were
born on 20 Mar 2017. The pretest body weight range was 310 - 327 grams for males and 185 - 216 grams
for females. The weight variation of the animals used did not exceed ±20% of the mean body weight of
the previously dosed animals within a sex.
The animals were identified by cage notation and indelible body marks, and housed in suspended wire
cages; five per sex per cage prior to dosing and three per sex per cage following dosing. Absorbent
paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rat
Chow (Diet No. 5012) was freely available except for 16-20 hours prior to dosing. Water was available ad
libitum. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a
12-hour light/dark cycle, and was kept clean and vermin free.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- ethanol
- Details on oral exposure:
- A single dose was administered orally by syringe and dosing needle at a dose level of 2000 mg/kg to
three female rats, at a dose level of 300 mg/kg to three female rats, and at a dose level of 1000 mg/kg to
three female rats and three male rats. - Doses:
- 300-1000-2000 mg/kg b.w.
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Type and Frequency of Observations
In Vivo - Animals were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for
toxicity and pharmacological effects and twice daily for mortality. Body weights were recorded
immediately pretest, weekly, at death and at termination in the survivors.
Post Mortem – All animals were humanely sacrificed using CO2 and were examined for gross pathology
following study termination.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One female rat survived following a single 2000 mg/kg oral dose. Two female rats were found dead by Day 3 following the single 2000 mg/kg oral dose.
Three female rats and two male rats survived following a single 1000 mg/kg oral dose. One male rat was found dead by Day 2 following the single 1000 mg/kg oral dose. All three female rats survived following a single 300 mg/kg oral dose. - Clinical signs:
- other: 2000 mg/kg Abnormal physical signs including piloerection, lethargy, ataxia, flaccid muscle tone, hunched posture, wetness and red staining of the nose/mouth area, diarrhea, soiling and yellow staining of the anogenital area, chromorhinorrhea, and chromod
- Gross pathology:
- 2000 mg/kg
The gross necropsy of the decedents revealed red and brown staining of the nose/mouth area, wetness and brown and yellow staining of the anogenital area, darker than normal liver, dark areas on the kidneys, and abnormalities of the gastrointestinal tract. The gross necropsy of the surviving animal
revealed no observable abnormalities.
1000 mg/kg
The gross necropsy of the decedent revealed red staining of the nose/mouth area, soiling of the anogenital area, darker than normal lungs, and abnormalities of the gastrointestinal tract. The gross necropsy of the surviving animals revealed no observable abnormalities.
300 mg/kg
The gross necropsy revealed no observable abnormalities.
Applicant's summary and conclusion
- Conclusions:
- The oral LD50 of 4,4’-Isopropylidenediphenyl, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with cyclohex-1,2-ylenediamine is greater than 1000 mg/kg but less than 2000 mg/kg of body weight in rats.
- Executive summary:
The oral LD50 of 4,4’-Isopropylidenediphenyl, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with cyclohex-1,2-ylenediamine is greater than 1000 mg/kg but less than 2000 mg/kg of body weight in rats.
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