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EC number: 202-625-6 | CAS number: 97-99-4
- 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:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-10-03 to 1995-01-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Tetrahydrofurfuryl alcohol
- EC Number:
- 202-625-6
- EC Name:
- Tetrahydrofurfuryl alcohol
- Cas Number:
- 97-99-4
- Molecular formula:
- C5H10O2
- IUPAC Name:
- tetrahydrofuran-2-ylmethanol
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Labs, Portage, MI, USA
- Age at study initiation: 6 wk
- Weight at study initiation: 155-203 (m); 129-159 (f) g
- Fasting period before study: no data
- Housing: 1/wire mesh cage
- Diet: standard diet at libitum
- Water: drinking water ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 +/- 4 deg F
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: To: 1994-10-03 to around 1995-01-03
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- clean air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 0.5 m3 stainless steel and glass inhalation chambers, dynamic operation
- Source and rate of air: filtered air, 12-15 chamber volumes/hr
- Temperature, humidity, pressure in air chamber: 19.7-25.8 deg C; 19-85 % RH
- Air change rate: 12-15 chamber volumes/hr
TEST ATMOSPHERE
- Brief description of analytical method used: infrared spectoscopic method , examination 3 times daily (no findings given in Volumer 1 of report) - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 6 hr/day, 5 days/wk, at least 65 exposures (equivalent to 13 weeks)
- Frequency of treatment:
- daily on weekdays
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 ppm (nominal)
- Dose / conc.:
- 150 ppm (nominal)
- Dose / conc.:
- 500 ppm (nominal)
- No. of animals per sex per dose:
- 10, with a further 4 males per concentration to examine spermatogenic effects
- Control animals:
- yes, concurrent vehicle
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice per day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once/week
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: weeks 0 and 12
HAEMATOLOGY: Yes
- Time schedule for collection of blood: weeks 3, 13
- Anaesthetic used for blood collection:No data
- Animals fasted: Yes
- How many animals: all survivors from main groups (10/sex/concentration)
- Parameters checked in table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood:
- Animals fasted: Yes
- How many animals: all survivors from main groups (10/sex/concentration)
- Parameters checked in table 1 were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: examination of groups of 4 males at week 6 and 10 males at week 13, at each concentration, for effects on spermatogenic endpoints - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes see table 2
HISTOPATHOLOGY: Yes see table 2 - Statistics:
- 2-tailed tests for minimum significance levels of 1% and 5%, comparing treatment groups to the vehicle control. Body weight, weight change, food consumption, clinical laboratory, spermatogenic and organ weight data were subjected to a 1-way analysis of variance and Dunnett’s test.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- testis
- Details on results:
- CLINICAL SIGNS AND MORTALITY
1/10 females died in at 50 ppm during week 0, the cause of death was not found to be treatment-related. The predominant clinical finding was intermittent whole-body spasms in all treated groups that were frequent and exposure-related. Hypoactivity and excessive grooming were occasionally observed in males and females at 500 ppm. One hour after exposure, concentration-related hyperactivity was reported in all treated groups, and yellow urogenital matting and salivation at 500 ppm.
BODY WEIGHT AND WEIGHT GAIN
Mean body weight gains were lower than controls in males at 150 and 500 ppm (9.2% and 13.3%, respectively).
FOOD CONSUMPTION
Mean food consumption was generally lower in mid and high exposure males throughout the study
OPHTHALMOSCOPIC EXAMINATION
No treatment-related observations.
HAEMATOLOGY
Several statistically significant treatment-related changes were reported after exposure to 500 ppm. Platelet and haemoglobin means were significantly reduced in both sexes (study weeks 3 and/or 13). MCH (mean cell haemoglobin) was reduced in males (weeks 3 and 13) and females (week 13); MCHC (mean corpuscular haemoglobin concentration) was reduced in males (week 13) and females (week 3).
CLINICAL CHEMISTRY
No treatment-related effect.
ORGAN WEIGHTS
Prostate weight (absolute and relative) were lower than controls in 150 and 500 ppm groups. The weights of seminal vesicles (absolute) and epididymides (absolute and relative) were lower at 500 ppm.
GROSS PATHOLOGY
No macroscopic lesions in any exposure group.
HISTOPATHOLOGY: NON-NEOPLASTIC
Spermatogenic findings: reduced epididymal sperm numbers and motility, and a higher incidence of morphological abnormalities were seen in 500 ppm males at weeks 6 and 13. Multifocal atrophy of the testes was reported in a single male at 500 ppm.
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 50 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: whole body spasm and hyperactivity, and other effects.
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
- Dose descriptor:
- LOAEC
- Effect level:
- 50 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: around 0.2 mg/l
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A well reported 90-day rat inhalation study, conducted according to the current guideline and in accordance with GLP, did not identify a NOAEC value. Clinical observations (including spasm) were evident at the lowest tested nominal concentration of 50 ppm (around 0.2 mg/l).
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