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EC number: 482-020-3 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP/Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 482-020-3
- EC Name:
- -
- Molecular formula:
- C8H12O2
- IUPAC Name:
- cyclohexane-1,3-dicarbaldehyde; cyclohexane-1,4-dicarbaldehyde
- Test material form:
- aerosol dispenser: not specified
- Remarks:
- migrated information: aerosol
- Details on test material:
- - Name of test material (as cited in study report): 1,3 and 1,4-Cyclohexanecarboxaldehyde
- Composition of test material, percentage of components: A mixture of 1,3-Cyclohexanedicarboxaldehyde and 1,4-Cyclohexanedicarboxaldehyde
- Lot/batch No.: Lot# 201001644 2nd pass Bottle # 1 and Bottle # 3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: F344/DuCrl
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Inc. (Kingston, New York)
- Age at study initiation: eight weeks
- Weight at study initiation:
- Fasting period before study:
- Housing: animals were housed two-three per cage in stainless steel cages. Cages had solid bottom floors
- Diet (e.g. ad libitum): LabDiet Certified Rodent Diet #5002 (PMI Nutrition International, St. Louis, Missouri) in pelleted form ad libitum except during the
2-hour acclimation period the day prior to exposure and during the 4-hour exposure period
- Water (e.g. ad libitum): municipal water was provided ad libitum except during the 2-hour acclimation period the day prior to exposure
and during the 4-hour exposure period
- Acclimation period: Animals were acclimated to the laboratory for at least one week prior to the start of the study. Animals were acclimated to the nose
cones for at least two hours on the day preceding exposure to the test material.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C (and a maximum permissible excursion of ± 3°C)
- Humidity (%):40-70%
- Air changes (per hr):10-15 times/hour (average)
- Photoperiod (hrs dark / hrs light): 12-hour light/dark (on at 6:00 a.m. and off at 6:00 p.m.)
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
A 42-liter, Dow-modified ADG nose-only chamber [30 centimeters (cm) in diameter by
60 cm high] was used for the study. Compressed filtered air supplied to the
chamber was at ambient temperature. Airflow through the chamber was determined with
a manometer which measured the pressure drop across a calibrated orifice plate and was
maintained at approximately 30 liters per minute, which was sufficient to provide the
normal concentration of oxygen to the animals and approximately 43 air changes per
hour. The manometer was calibrated with a gas meter (Model DTM-115, Singer
Aluminum Diaphragm Meter, American Meter Division, Philadelphia, Pennsylvania)
prior to the start of the study. The chamber was operated at a slightly positive pressure
relative to the surrounding area and was contained within a secondary vented area.
Chamber and exposure room temperature were recorded from two thermocouples
attached to an electronic digital thermometer (Omega Engineering, Inc., Bridgeport, New
Jersey), one thermocouple extended into the exposure chamber and the second was
stationed next to the chamber. Chamber relative humidity was monitored by a
hygrometer (VWR, West Chester, Pennsylvania) stationed in the interior of the chamber.
Low relative humidity values were expected for exposures of this type, since dry,
compressed air was the only source of air supplied to the chamber. Therefore, the
chamber make-up air was passed through a Model 5-60 DRI-STEEM humidifier filled
with distilled water to humidify the air to a level more suitable for the animals.
Based on the 30 liter per minute flow rate, the theoretical equilibrium time to 99% (T99)
of the target concentration was 6.4 minutes. The animals were placed on the chamber
after the T99 had elapsed and were removed after 240 minutes of exposure.
VEHICLE
The mass concentration of aerosol present in the chamber was determined gravimetrically
three times during the exposure period. Samples were taken by drawing air, at
1 L/minute, through a sampling probe located in the breathing zone of the animals.
Aerosol particles were collected on pre-weighed glass fiber filters (PALL
Corporation, Ann Arbor, Michigan) and charcoal sorbent tubes (SKC, Eighty Four,
Pennsylvania). Background measurements of the chamber were taken after placing
animals on the chamber and prior to starting the exposure. After each atmosphere
sampling, the filter and tubes were re-weighted to obtain the total weight of the particles.
The time-weighted average (TWA) exposure concentration was calculated from the
gravimetric measurements after the subtraction of the background measurements.
The nominal concentration was calculated based on the amount of test material fed into
the generation system divided by the total chamber airflow.
TEST ATMOSPHERE (if not tabulated)
The aerodynamic particle size was determined twice during the exposure period by
drawing samples from within the animal breathing zone, at a set rate using a constant
flow air sampling pump through a multi-stage mercer-style cascade impactor.
The MMAD and geometric standard deviation (GSD) were determined for each sample
as well as the average of the samples.
A sorbent tube was placed in-line following the cascade impactor to trap vapors to
prevent contamination of the pump used to draw the samples. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.22 mg/l
- 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 observations and weighing: Animals were weighed and examined prior to exposure to the test material and observed
at least every 30 minutes during the exposure period. All rats were weighed on test days 2, 4, 8, 11, and 15 during the two-week post-exposure period.
- Necropsy of survivors performed: yes
- Other examinations performed: Detailed clinical observations (DCO) were conducted pre-exposure, twice on test day 1 vfollowing the exposure and daily
thereafter. - Statistics:
- Means and standard deviations were calculated for descriptive purposes for chamber
concentration (mean only), animal body weights, exposure room temperature and
chamber temperature, humidity, and airflow.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- > 5.22 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- All animals survived the four-hour exposure to the test material as well as the two-week
post-exposure period. - Clinical signs:
- other: Clinical effects noted during the four-hour exposure period were limited to soiling of the haircoat in one male and three female rats. In-life observations noted post-exposure included perineal, perinasal and/or extensive body soiling in four males and t
- Body weight:
- Mean body weight losses of 11.4% and 6.7% were noted for male and female rats,
respectively, on test day 2. Pre-exposure mean body weight values
were exceeded on test day 8. - Gross pathology:
- There were no treatment-related visible lesions noted in any of the rats exposed to 1,3-
and 1,4-cyclohexanecarboxaldehyde at the test day 15-scheduled necropsy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these data, the four-hour LC50 of inhaled 1,3- and 1,4- cyclohexanecarboxaldehyde is greater than 5.22 mg/L for male and female F344/DuCrl rats.
- Executive summary:
This study was conducted to determine the acute inhalation toxicological properties of 1,3- and 1,4-cyclohexanecarboxaldehyde. Groups of five rats/sex were exposed for four hours, using a nose-only inhalation exposure system, to a time-weighted average chamber
concentration of 5.22 mg 1,3- and 1,4-cyclohexanecarboxaldehyde per liter of air. The mass median aerodynamic diameter (MMAD) of particulate 1,3- and 1,4- cyclohexanecarboxaldehyde present in the exposure chamber test atmosphere averaged 3.71 microns with an average geometric standard deviation of 2.11 microns. All animals survived the four-hour exposure to the test material as well as the two-week post-exposure period. Clinical effects noted during the four-hour exposure period were limited to soiling of the haircoat in one male and three female rats. In-life observations noted post-exposure included perineal, perinasal and/or extensive body soiling in four males and three females, noisy respiration in one male and a partially closed eye in one female. All rats appeared normal by test day 6. Mean body weight losses of 11.4 and 6.7% were noted for male and female rats, respectively, on test day 2. Pre-exposure mean body weight values were exceeded on test day 8. There were no visible treatment related lesions noted in any of the rats exposed to 1,3- and 1,4 -cyclohexanecarboxaldehyde at the test day 15-scheduled necropsy. Based on these data, the four-hour LC50 of inhaled particulate 1,3- and 1,4- cyclohexanecarboxaldehyde is greater than 5.22 mg/L for male and female F344/DuCrl rats.
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