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EC number: - | 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
- 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:
- 28 September 2020 - 27 October 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid
- Molecular formula:
- C44H86N2O4
- IUPAC Name:
- Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- white
- Details on test material:
- Chemical registery number : 951-139-7
Chemical name : Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 9-10 weeks old
- Weight at study initiation: 140 to 196 g
- Fasting period before study: Yes, o/n (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item. Water was available.
- Housing: animals were group housed (up to 3 animals of the same sex and same dosing group together) in polycarbonate cages containing sterilized wooden fibers as bedding material equipped with water bottles.
- Animal enrichment: animals were provided with paper, except when interrupted by study procedures/activities.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum (except during designated procedures). The feed was analyzed by the supplier for nutritional components and environmental contaminants.
- Water: Municipal tap water, ad libitum. Periodic analysis of the water was performed.
- Contaminants: It is considered that there were no known contaminants in the feed or water that would interfere with the objectives of the study.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C (target range); 21°C (actual daily mean)
- Humidity (%): 40 to 70% (target range); 40 to 65% (actual daily mean)
- Air changes (per hr): 10 or greater air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
IN-LIFE DATES: From: 29 September 2020 To: 27 October 2020
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Supplier: Sigma-Aldrich, Steinheim, Germany
- Justification for choice of vehicle: Trial preparations were performed to select the suitable vehicle and to establish a suitable formulation procedure. These trials were not performed as part of this study and these preparations were not used for dosing.
- Specific gravity: 0.92
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight
CLASS METHOD
- Rationale for the selection of the starting dose: The dose levels were based on the OECD test guidelines and were selected from the series 5 (lowest dose level), 50, 300 and 2000 (highest dose level) mg/kg body weight. The starting dose level should be the one that is likely to produce mortality in at least some of the animals and was selected based on available toxicity data of the test item. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- Group 1: 3 females
Group 2: 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Post-dose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter.
- Frequency of weighing: Day 1 (pre-dose), 8 and 15. A fasted weight was recorded on the day of dosing.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Hunched posture and erected fur were noted for all animals between Days 1 and 3. Three animals also showed pale/orange colored feces between Days 1 and 9.
- Gross pathology:
- An abnormality of the kidney (right enlarged) in one animal and the thoracic body cavity (dark red fluid accumulation) in another animal was found at macroscopic post mortem examination. Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities.
An abnormality of the clitoral gland (dark tanned bilateral multifocal foci) was observed in one animal, however, this is more often seen in rats of this strain in this kind of study and therefore no toxicological relevance was attached to this finding.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an acute oral study, performed according to OECD guideline 423 and in accordance with GLP principles, the oral LD50 value of Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) in Wistar Han rats was determined to exceed 2000 mg/kg bodyweight. As a consequence, Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) is not classified according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
- Executive summary:
An acute oral study was performed according to OECD guideline 423 and in accordance with GLP principles, six female rats were exposed at test item concentration of 2000 mg/kg bodyweight and observed for 14 days. No mortality occured. Hunched posture and erected fur were noted for all animals between Days 1 and 3. Three animals also showed pale/orange colored feces between Days 1 and 9. The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. An abnormality of the kidney (right enlarged) in one animal and the thoracic body cavity (dark red fluid accumulation) in another animal was found at macroscopic post mortem examination. Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities. The oral LD50 value of Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) in Wistar Han rats was established to exceed 2000 mg/kg body weight. Based on these results, Reaction products of 1,3-cyclohexanedimethanamine and 12-hydroxystearic acid (BA-1801) does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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