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EC number: 224-809-5 | CAS number: 4500-29-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- other: Guideline Study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-(cyclohexylimino)bisethanol
- EC Number:
- 224-809-5
- EC Name:
- 2,2'-(cyclohexylimino)bisethanol
- Cas Number:
- 4500-29-2
- Molecular formula:
- C10H21NO2
- IUPAC Name:
- 2,2'-(cyclohexylimino)bisethanol
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
Test system: Rat, HanRcc:WIST (SPF)
Rationale: Recognized by the international guidelines as a recommended test system.
Source: RCC Ltd, Laboratory Animal Services, CH-4414 Füllinsdorf / Switzerland
Number of animals per group 3 females
Total number of animals 12 females
Age when treated: 12-13 weeks
Identification: Unique cage number and corresponding color-coded spots on the tail. The animalswere marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization:
Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
HUSBANDRY
Room no.: 0105 / RCC Ltd, Füllinsdorf
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch nos. 25/05 and 39/05 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd.
Water: Community tap water from FOllinsdorf ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- (purified)
- Details on oral exposure:
- VEHICLE
The following information was provided by RCC Ltd:
Purified water prepared at RCC Ltd (deionised water which was processed and treated by the PURELAB Option-R unit. This latter links four purification technologies: reverse osmosis,adsorption, ion-exchange and photo oxidation). Purified water was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solUbility trial which was performed before the study initiation date. This formulation trial is excluded from the GLP statement of compliance. - Doses:
- 2
- No. of animals per sex per dose:
- 6 females per dose group
- Control animals:
- no
- Details on study design:
- DOSE FORMULATION
Dose levels are in terms of the test item as supplied by the sponsor.
The dose formulations were made shortly before each dosing occasion using a magnetic
stirrer as homogenizer. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weightvolume). Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
TREATMENT
The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg or 300 mg/kg body weight after being fasted for approximately 17 to 19 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing. The application volume was 10 mL/kg body weight.
Rationale: Oral administration was considered to be an appropriate application method as it is a possible route of human exposure during manufacture, handling and use of the test item.
OBSERVATIONS
Mortality / Viability
Body weights
Clinical signs
Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. On test days 1 (prior to administration), 8 and 15. Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15. All abnormalities were recorded. - Statistics:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 given as "cut off value"
- Mortality:
- 2000 mg/kg body weight: 2/6
300 mg/kg body weight: 0/6 - Clinical signs:
- other: 2000 mg/kg body weight: ruffled fur, hunched posture, sedation 300 mg/kg body weight: no clinical signs of intoxication
- Gross pathology:
- All animals which died spontaneously during the observation period were necropsied as soon as they were found dead. All surviving animals at the end of the observation period.
- Other findings:
- MACROSCOPIC FINDINGS
In three animals treated at 2000 mg/kg, liquid contents were found in the stomach and/or duodenum, jejunum, ileum and caecum at necropsy, whereas no macroscopic findings were recorded in the remaining animals.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the OECD 423, the LD50 - cut off value of the test substance after single oral administration to female rats, observed over a period of 14 days is:
LD50 - cut off value (female rat) = 2000 mg/kg b.w. - Executive summary:
Four groups, each of three female HanRcc:WIST (SPF) rats, were treated with the test substance by oral gavage administration at a dosage of 2000 mg/kg or 300 mg/kg body weight. The test item was diluted in vehicle (purified water) at a concentration of 0.2 g/mL or 0.03 g/mL and administered at a volume dosage of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. The following animals were treated and percentage of mortality was observed:
6 females treated at 2000 mg/kg 33 %
6 females treated at 300 mg/kg 0 %
Two animals treated at 2000 mg/kg were found dead four or six hours after treatment, whereas all animals treated at 300 mg/kg survived until the end of the study period. Slightly to moderately ruffled fur was observed in five animals treated at 2000 mg/kg from the 30-minute or 1-hour reading to the 2-hour examination and persisted in four of these animals up to the 3- or 5-hour observation or until test day 4. Hunched posture was noted in two animals at the 1-hour reading and persisted in one female until the 2-hour reading, whereas three other animals showed this symptom from the 2- to 3- or 5-hour observation or at the 3-hour examination only. Slight to moderate sedation was noted in four animals at the 1-hour reading and persisted in three of them until two, three or five hours after treatment. Slight to moderate tremor was seen in two animals treated at 2000 mg/kg prior to their spontaneous death three or five hours after treatment. Ventral recumbency was noted in one of these animals at the 5-hour reading. No clinical signs were observed during the course of the study in all animals treated at 300
mg/kg. The body weight of the animals was within the range commonly recorded for this strain and age. In three animals treated at 2000 mg/kg, liquid contents were found in the stomach and/or duodenum, jejunum, ileum and caecum at the unscheduled necropsy, whereas no macroscopic findings were recorded in the remaining animals.
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