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EC number: 603-894-6 | CAS number: 135108-88-2
- 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:
- 2005-02-14 to 2005-03-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (2004)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine
- EC Number:
- 603-894-6
- Cas Number:
- 135108-88-2
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- 2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine
- Test material form:
- liquid: viscous
- Details on test material:
- Copolymer of aniline and formaldehyde, hydrogenated of Degussa AG, batch no. 923-050110 of 10 Jan. 2005.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: White Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- Source: White WISTAR, Harlan Winkelmann, Borchen, Germany
- Weight at study initiation: 165.2 - 199.0 g, about 9 weeks
- Fasting period before study: maximum 20 hours
- Diet: Altromin, rat diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 22 °C +/- 3° C
- Humidity (%): 30 % - 70 %
- Air changes (per hr): 8 times
- Illumination: 12 hours artifical fluorescent light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- ADMINISTRATION:
- Frequency: single dosage on day 1
- Dose: 300 mg/kg/bw (applied as 10 % w/w) and 50 mg/kg bw (applied as 5 % w/w)
- DOSAGE PREPARATION: dispersion in sesame oil
- Starting dose 300 mg/kg bw, next step 50 mg/kg bw - Doses:
- 300 mg/kg/bw and 50 mg/kg bw
- No. of animals per sex per dose:
- 3 female at 300 mg/kg
6 female at 50 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: periodic intervals on the dayof dosing and once daily thereafter, until day 15
- Body weight: days 1 (pre-administration) 8 and 15
- Necropsy: Animals died ahead of schedule were necropsied immediately, all survived animals were necropsied at the end of the observation period - Statistics:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 50 - < 300 mg/kg bw
- Mortality:
- 300 mg/kg: 2 of 3 female rats died within 20 minutes after application
50 mg/kg: no mortality - Clinical signs:
- other: 300 mg/kg: 2 of 3 female rats showed ataxia, decreased respiration, gasping, side position and convulsion, died within 20 minutes after application 50 mg/kg: no toxic symptoms were observed
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Other findings:
- no other findings
Any other information on results incl. tables
no other information
Applicant's summary and conclusion
- Conclusions:
- The LD50 cut-off for VESTAMIN EP-HS 10 was estimated to be 300 mg/kg. Ranking of the test substance VESTAMIN EP-HS 10 according to the Global Harmonised System resulted in Category 3: > 50 - 300 mg/kg
- Executive summary:
The acute oral toxicity study of VESTAMIN EP-HS 10 was determined with 9 female WISTAR rats. Animals were observed for symptoms of clinical toxicity and mortality for 14 days after treatment. At first 3 female rats were treated with 300 mg/kg bw. Two rats showed ataxia, decreased respiration, gasping, side position and convulsion and died within 20 minutes after application. Necropsy immediatley after the death showed no substance related morphological visible pathologic organ findings. The remaining animal showed no toxic symptoms . After that, 2 groups of 3 female rats were dosed with 50 mg/kg. No toxic symptoms were observed and no death occurred. No apparent changes were found in body weights of remaining rats. All survived animals showed
no substance related morphological visible pathologic organ findings.
The LD50 cut-off for VESTAMIN EP-HS 10 is 300 mg/kg. Ranking of the test substance VESTAMIN EP-HS 10 according to the Global Harmonised System resulted in Category 3: > 50 - 300 mg/kg
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