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EC number: 202-627-7 | CAS number: 98-01-1
- 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

Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented publication, comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- yes
- Remarks:
- microscopic examination of kidneys, liver, lungs, spleen, thymus, nose, larynx and trachea only; no measurement of MCV, MCH, MCHC, reticulocytes, globulin.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Furfural (2-furaldehyde)
- IUPAC Name:
- Furfural (2-furaldehyde)
- Reference substance name:
- 2-furaldehyde
- EC Number:
- 202-627-7
- EC Name:
- 2-furaldehyde
- Cas Number:
- 98-01-1
- Molecular formula:
- C5H4O2
- IUPAC Name:
- 2-furaldehyde
- Details on test material:
- - Name of test material (as cited in study report): furfural
- Physical state: colourless oily liquid with a pungent aromatic odour
- Analytical purity: >=99%
- Other: obtained from Sigma/Aldrich (Brussels, Belgium)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: young adults
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: 5/sex/cage in macrolon cages with sterilized bedding (during exposure: individually restrained in Batelle tubes for nose-only exposure)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: no data To: no data
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: nitrogen gas diluted with humidified air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Batelle tubes
- Method of holding animals in test chamber: individually restrained in Batelle tubes, nose-only exposure
- Source and rate of air: 18-34 changes per hour.
- Method of conditioning air: Air was humidified using water kept at 39°C.
- System of generating particulates/aerosols: Nitrogen gas was bubbled through all glass evaporators filled wih furfural and held at 23°C. In the inhalation unit containing the Batelle tubes, this test atmosphere was diluted with humidified compressed air.
- Temperature, humidity, pressure in air chamber: daily mean temperature in range 22.1-22.8°C, standard deviation 0.4°C; daily mean humidity in range 43-44%, standard deviation 2-4%;
- Air flow rate: 15-28 L/min
- Air change rate: 18-34 air changes per hour.
- Method of particle size determination: not relevant
- Treatment of exhaust air: no data
TEST ATMOSPHERE
- Brief description of analytical method used: Furfural concentrations in the test atmosphere were semi-continuously determined by infrared analysis at 9.8 µm using two monitors. Prior to the first exposure, the infrared analysers were calibrated, one for the high levels in the range of 30-1500 mg/m3, the other for the lower concentrations in the range of 30-200 mg/m3 (correlation coefficients >0.996). One day after the last exposure, the integrity of the calibration was approved again.
- Samples taken from breathing zone: no data
VEHICLE (if applicable)
- Justification for use and choice of vehicle: no data
- Composition of vehicle: nitrogen gas
- Type and concentration of dispersant aid (if powder): not relevant
- Concentration of test material in vehicle: no data (not relevant)
- Lot/batch no. of vehicle (if required): no data
- Purity of vehicle: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Furfural concentrations in the test atmosphere were semi-continuously determined by infrared analysis at 9.8 µm using two monitors. Prior to the first exposure, the infrared analysers were calibrated, one for the high levels in the range of 30-1500 mg/m3, the other for the lower concentrations in the range of 30-200 mg/m3 (correlation coefficients >0.996). One day after the last exposure, the integrity of the calibration was approved again.
The mean (standard deviation) measured concentrations of furfural were 20(1), 41(1), 80(3), 158(3), 316(8) mg/m3 for the 6-h exposure groups (target concentrations of 20, 40, 80, 160 and 320 mg/m3 respectively) and 157(4), 314(1) and 635(24) mg/m3 for the 3-h exposure groups (target concentrations of 160, 320 and 640 mg/m3 respectively). - Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 6 h/day (0, 20, 40, 80, 160, 320, 640 and 1280 mg/m3) or 3 h/day (160, 320, 640 and 1280 mg/m3).
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 40, 80, 160, 320, 640 and 1280 mg/m3 (6 h/day exposure) or 160, 320, 640 and 1280 mg/m3 (3 h/day exposure)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: once or twice weekly.
FOOD CONSUMPTION: weekly
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes (parameters according to OECD 412, exception: MCV, MCH, MCHC, reticulocytes not measured))
- Time schedule for collection of blood: sacrifice
- Anaesthetic used for blood collection: no data
- Animals fasted: Yes
- How many animals: all surviving animals
CLINICAL CHEMISTRY: yes (parameters according to OECD 412, exception: globulin not measured)
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (weighing of liver, kidneys, adrenals, brain, heart, spleen, thymus, testes, lungs)
HISTOPATHOLOGY: Yes (from weighed organs and complete respiratory tract). - Statistics:
- Body weight data using one way analysis of covariance using pre-exposure weights as covariate. Organ weights and haematological and clinico-chemical data using one way analysis of variance. If significant differences among the means were indicated, this was followed by Dunnett’s test. Relative differential WBC counts by Kruskall-Wallis ANOVA followed by Mann-Whitney U-test. Incidence of histopathological changes by Fisher’s exact test. All comparisons were two-tailed, significance was tested at the 5% level.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- See below under "Details on results".
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- See below under "Details on results".
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Statement only, no tabulated data shown.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Statement only, no tabulated data shown.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- Statement only, no tabulated data shown.
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Statement only, no tabulated data shown.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Statement only, no tabulated data shown. Publication stated: except perhaps the small increase in organic phosphate in females exposed to 320 mg/m3 for 6 h/day.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- See below under "Details on results".
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- See below under "Details on results".
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Mortality: At the end of the first exposure day, all animals exposed to 1280 mg/m3 were found dead. Up to day 8, five animals of the 640 mg/m3 group (6 h/day exposure) were found dead, and exposure of this group was discontinued. No other mortalities occurred.
Clinical signs: during exposure breathing abnormalities (i.e. decreased breathing frequency) at 80 mg/m3 and higher. No other clinical signs were observed.
Organ weights: Increased absolute and relative liver weights (statistically significant) were observed in males at 80 mg/m3 for the 6-h/day exposure. Increased relative spleen weights (statistically significant) were observed in males at 80 mg/m3 for the 6-h/day exposure, and decreased relative spleen weights (statistically significant) in females at 320 mg/m3 for the 3-hour exposure. These changes are considered to be due to biological variation, in the absence of a dose-relationship and/or a relationship with the duration of exposure. Decreased absolute and relative liver weights were observed in females at 160, 320 and 640 mg/m3 for the 3 h/day exposure (statistically significant except for absolute liver weights at 320 mg/m3). No dose-relationship existed, however, in the range 160-640 mg/m3 for the 3 h/day exposure, and there were no changes in absolute and relative liver weights at 160 and 320 mg/m3 for the 6 h/day exposure. Therefore these changes are also considered to be fortuitous and unrelated to the treatment.
Histopathology: Microscopic examination of the preserved organs revealed treatment-related changes in the nasal passages only. The histopathological changes observed consisted of respiratory epithelial lesions such as squamous metaplasia and atypical hyperplasia, and olfactory epithelial changes characterised by epithelial disarrangement. The histopathological changes observed in the respiratory epithelium were seen in all 6 h/day exposure groups (at 20 mg/m3 and higher) whereas the olfactory epithelial disarrangement was seen at 80 mg/m3 and above. In addition, at the exposure concentrations of 20 and 40 mg/m3, the transitional epithelium located in the anterior part of the nose was affected in all exposed animals, whereas the lining epithelium more posterior in the nose was affected in one or two animals of these groups only. At 80 mg/m3 and above, exposure related changes of the lining epithelium more posterior in the nose were seen at a higher incidence and degree. Similar lesions were observed in animals exposed for 3 h/day, however at a lower incidence and degree when compared to animals exposed for 6 h/day at half the concentration.
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Remarks:
- systemic (6 h/day exposure)
- Effect level:
- 320 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: mortality at 640 mg/m3
- Dose descriptor:
- NOAEC
- Remarks:
- local effects
- Effect level:
- < 20 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: histopathological changes in the nasal passage.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- For the 6-h/day exposure, the only treatment-related systemic finding was mortality at 640 mg/m3 and above. The histopathological findings are considered to be local and not systemic effects. Based on this, the NOAEC for systemic effects for the 6 h/day exposure was 320 mg/m3 (LOAEC 640 mg/m3 based on mortality). The NOAEC for local effects for the 6 h/day exposure was <20 mg/m3 (LOAEC 20 mg/m3) based on metaplasia and atypical hyperplasia of the transitional respiratory epithelium in the anterior part of the nose, and epithelial disarrangement of the olfactory epithelium.
The systemic NOAEC for the 3 h/day exposure was 640 mg/m3 (LOAEC 1280 mg/m3). The endpoints from the 3 h/day exposure are not considered to be appropriate endpoints, since OECD 412 prescribes a 6 hour/day exposure.
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