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EC number: 948-816-4 | CAS number: -
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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- Specific investigations
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 2018 - May 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 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
Test material
- Reference substance name:
- Reaction products of acrylonitrile and 2-methylcyclohexane-1,3-diamine and 4-methylcyclohexane-1,3-diamine, hydrogenated
- EC Number:
- 948-816-4
- Molecular formula:
- C13H30N4
- IUPAC Name:
- Reaction products of acrylonitrile and 2-methylcyclohexane-1,3-diamine and 4-methylcyclohexane-1,3-diamine, hydrogenated
Constituent 1
- Specific details on test material used for the study:
- Batch identification: Bähr63/Dest/F4-5
Test item No.: 17/0592-1
Physical state / color: Liquid / colorless to yellowish, clear
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Young adult animals (female animals approx. 10 weeks)
Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Route of administration: Single oral administration by gavage.
Fasting period: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
Time of day of administration: In the morning
Observation period: 14 days - Doses:
- 300, 2000 mg/kg bw/d
- No. of animals per sex per dose:
- 3 females/dose
- Control animals:
- no
- Details on study design:
- For the high dose, the liquid test item was administered unchanged. For the lower dose, an administration volume of 2 ml/kg bw of suitable test item preparations was used to facilitate administration.
Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the day of death on study day 1.
Clinical observations: Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
Mortality: A check for any dead or moribund animals was made at least once each workday; these records are archived by Bioassay.
Pathology: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations. Necropsy of all animals that died as early as possible after death.
Histology: No histological examinations were performed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In the 2000 mg/kg bw test group all animals died within hour 1, 4 or day 1 after administration, respectively.
No mortality occurred in both 300 mg/kg bw test groups. - Clinical signs:
- In the 2000 mg/kg bw test group impaired general state was seen in all animals at hour 0, hour 1 or from hour 1 until hour 2 after administration. Impaired general state progressed to poor general state was seen in two out of three animals at hour 3 or from hour 2 until hour 5.
Dyspnoea and piloerection were observed in all animals at hour 0 or from hour 1 until hour 3 or 5 after administration.
Abdominal position was seen in one animal at hour 3, while cowering position was seen noted in another animal from hour 2 until hour 5. In this animal apathy was noticed from hour 4 until hour 5 after administration.
In the first 300 mg/kg bw test group impaired general state and piloerection were noticed observed in all animals from hour 3 until hour 4 or 5 after administration.
In the second 300 mg/kg bw test group impaired general state, dyspnoea and piloerection were noticed in all animals from hour 1 or 2 until hour 5 after administration. Cowering position was seen in two of these animals at hour 4 and persisted in one of these animals until hour 5 after administration. - Body weight:
- The body weight of the surviving animals increased within the normal range throughout the study period.
- Gross pathology:
- The following macroscopic pathologic findings were observed in the animals that died in the 2000 mg/kg bw test group:
o Red discoloration of the glandular stomach in all animals
o Red discoloration of the stomach contents in all animals
o Red discoloration of the small intestine in two animals
o Dark spotted discoloration of the liver in all animals
o Congestion of the kidneys in one animal
o Dark discoloration of the spleen in two animals
There were no macroscopic pathological findings in any animal sacrificed at the end of the observation period (300 mg/kg bw: 6 females).
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this study the median lethal dose of Reaction mass of N1,N3-bis(3-aminopropyl)-2-methyl-cyclohexane-1,3-diamine and N1,N3-bis(3-aminopropyl)-4-methyl-cyclohexane-1,3-diamine after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats.
- Executive summary:
Under the conditions of this study the median lethal dose of Reaction mass of N1,N3-bis(3-aminopropyl)-2-methyl-cyclohexane-1,3-diamine and N1,N3-bis(3-aminopropyl)-4-methyl-cyclohexane-1,3-diamine after oral administration was found to be greater than 300 mg/kg bw and less than 2000 mg/kg bw in rats (BASF, 2018).
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