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EC number: 700-868-7 | CAS number: 54889-63-3
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to current guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (1r,4r)-1,4-bis(ethoxymethyl)cyclohexane; (1s,4s)-1,4-bis(ethoxymethyl)cyclohexane
- EC Number:
- 700-868-7
- Cas Number:
- 54889-63-3
- Molecular formula:
- C12 H24 O2
- IUPAC Name:
- (1r,4r)-1,4-bis(ethoxymethyl)cyclohexane; (1s,4s)-1,4-bis(ethoxymethyl)cyclohexane
- Details on test material:
- - Name of test material: 1,4-bis(ethoxymethyl)-Cyclohexane 97%
- Physical state/Appearance: Liquid / colorless, clear
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 11 weeks
- Weight at before exposure (day 0): mean = 227.4
- Fasting period before study: no fasting
- Housing: air conditioned rooms, Typ III polycarbonate cages, Wooden gnawing blocks as enrichment, single housing or up to 5 animals, Dust-free wooden bedding
- Diet: Kliba laboratory diet, mouse/rat maintenance “GLP”, 12 mm pellets ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days before exposure
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-50 % for relative humidity
- Air changes: 15 per hour
- Photoperiod (dark/light): 12 hours / 12 hours
Experimental starting date: 22 Feb 2016
Day of last observation: 08 Mar 2016
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose-only inhalation system INA 20 (glass-steel construction, BASF SE
- Exposure chamber volume: approx. 55 L
- Method of holding animals in test chamber: restrained in glass tubes and their snouts projected into the inhalation system
- Source and rate of air: 1.5 m³/h
- Method of conditioning air: The central air conditioning system provides cold air of about 15°C. This cold air passes through an activated charcoal filter, is adjusted to room temperature of 20 to 24°C and passes through a second particle filter (H13 (HEPA) Camfil Farr, Germany).
- System of generating particulates/aerosols: The aerosol was produced by continuously pumping amounts of the test substance into the two-compnent atomizer. Equipement: Two-component atomizer Mod. 970 (stainless steel, Schlick), Continuous infusion pumps PHD Ultra (Harvard Apparatus,
Inc., Holliston, Massachusetts, U.S.A.)
- Method of particle size determination: Analysis by GC
- Treatment of exhaust air: The exhaust air was filtered and conducted into the exhaust air of the building (air flow 1.35 m³/h)
- Temperature, humidity, pressure in air chamber: 21.6 °C temperature, 17.4 (%) relative humidity, 1.5 bar atomizer pressure
TEST ATMOSPHERE
- Brief description of analytical method used: GC (System: Shimadzu 2010 with autosampler, FID, Dionex Chromeleon-Software (Dionex), or equivalent system; Column: Length: 30 m, Inner diameter: 0.25 mm, Film thickness: 0.25 µm; Stationary phase: Rtx-5 Amine, Restek or equivalent; Sample solution: Samples are diluted completely with isopropanol using appropriate volumetric flasks to obtain sample solutions with test substance concentrations that match the calibration range; Retention time for test substance: approx. 10 min)
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- Particle size distribution: Mass < 3 µm: 60.9 %
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.2 µm and 2.3 µm with GSD of 2.8 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.207 mg/L with 0.1 standard deviation
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of clinical observations: Clinical observations were recorded for each animal before exposure, separately several times during exposure (usually hourly) and after exposure. At least once daily on the preexposure day and during the post exposure observation period.
- Frequency of weighing: Individual body weights once during the acclimatization period, shortly before exposure (day 0) and at least on days 1, 3 and 7, and before the sacrifice of the animals at the end of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, Feed and Water - Statistics:
- The binomial test was used for statistical evaluation.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.207 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred at the tested concentration.
- Clinical signs:
- other: Clinical signs of toxicity comprised of red encrusted nose, abdominal respiration indicating local irritation effect. Moreover, piloerection and substance contaminated fur. The effects were observed after exposure until the study day 1. No clinical signs
- Body weight:
- The mean body weights of the animals decreased on the first post exposure observation day but increased thereafter.
- Gross pathology:
- No gross pathological abnormalities were detected during the necropsy in the animals at the termination of the study.
Any other information on results incl. tables
Clinical observations
Table 1: Duration of signs
Test group 1 (5.207 mg/L) |
Male animals |
Female animals |
Fur, substance contaminated |
d0 - d1 |
d0 - d1 |
Nose, red encrusted |
d0 |
d0 |
Respiration, abdominal |
d0 |
d0 - d1 |
Piloerection |
d0 - d1 |
d0 - d1 |
No abnormalities were detected in the animals during the post exposure observation period from study day 2 onwards.
Exposure conditions
Table 2: Exposure conditions
Supply air (m³/h) |
Exhaust air (m³/h) |
Test substance flow (mL/h) |
Atomizer pressure (bar) |
Temperature (°C) |
Relative humidity (%) |
1.5 ± 0.0 |
1.3 ± 0.0 |
23 ± 0.0 |
1.5 ± 0.0 |
21.6 ± 0.1 |
17.4 ± 0.8 |
Concentration measurements
Table 3: Analytical concentrations
Mean (mg/L) |
Standard deviation |
Nominal concentration (mg/L) |
5.207 |
0.100 |
13.8 |
Particle size analysis
Table 4: Results
Sample |
MMAD (µm) |
Geometrical standard deviation |
1 |
2.3 |
2.8 |
2 |
2.2 |
2.8 |
Statistical Evaluation
LC50(both sexes combined): > 5.207 mg/L (statistical significant to a level of 99 %)
LC50(male rats): > 5.207 mg/L (statistical significant to a level of 95 %)
LC50(female rats): > 5.207 mg/L (statistical significant to a level of 95 %)
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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