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Diss Factsheets
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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
![](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
- Study period:
- not reported
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Reviewers' note: The Japanese relevant authority have stated clearly in secondary summaries that this study was conducted in compliance with GLP. However, some pages, which may contain the confirmation of GLP compliance, are missing from the published study report."
Reviewer's note: The study report is a translation from Japanese and does not include the date of the study. However, the OECD SIDS references the study year as 2004. - GLP compliance:
- yes
- Remarks:
- (Certificate is not included in the study report.
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
- Details on test material:
- - Name of test material (as cited in study report): Tetrahydrofurfuryl alcohol
- Physical state: colourless, transparent liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan Inc. (795 Shimofurusawa, Atsugi-shi, Kanagawa)
- Age at study initiation: 10 weeks old
- Weight at study initiation: Step 1: mean bodyweight; 214 g (205-225 g)
Step 2: mean bodyweight; 215 g (207-219 g)
- Fasting period before study: No feeding performed from PM 5 on previous day of treatment to 3-hours after treatment.
- Housing: Test animals were bred in a stenless metal mesh cage (260W x 380D x 180H mm) in a barrier system animal room (No.8).
- Diet (e.g. ad libitum): Solid feed, labo MR stock, Nosan Corporation, Lot. No. 020765, ad libitum
- Water (e.g. ad libitum): Tap water sterilized by filteration with 1 µm diameter carteidge filter and UV radiation. ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- (purified water)
- Details on oral exposure:
- VEHICLE;
The test substance is soluble in water, therefore, pharmacopoeia purified water was selected as vehicle.
Pharmacopoeia purified water: Kyoei Pharmaceutical Co., Ltd. Lot. No. 181376
- Concentration in vehicle: 20w/v%
- Amount of vehicle (if gavage): 10 mL per 1 kg of body weight
DOSAGE PREPARATION;
The test solution was prepared immediately before treatment.
Starting dose;
Fixed dose level was adopted according to OECD guideline 423 and dose level was set as 2000 mg/kg in accordance with the report that LD50 value by oral treatment of the test substance in rat was reported as 1.6 to 3.2 g/kg. - Doses:
- 2000 mg/kg bw Step 1
2000 mg/kg bw Step 2 - No. of animals per sex per dose:
- Step 1; 3 animals
Step 2; 3 animals - Control animals:
- no
- Details on study design:
- Observation period was for 14 days following administration. Observation of clinical signs and confirmation of death were performed at least once an hour after the administration between 1 and 3 hours, and between 3 and 6 hours after administration on Day 1 (the day of administration). Observation was performed once each in the morning and in the afternoon on Day 2, once in the morning from Day 3 and later. Body weight was measured on Day 1 (immediately before administration), 4, 8 and 15. After observation on Day 15, animals were anesthetized by ether and euthanized and gross necropsy was performed on internal organs. Clinical sings only was observed daily on animals that were not administered.
- Statistics:
- No statistical analysis was carried out.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortalities occurred in response to treatment.
- Clinical signs:
- other: Mild hyptoni and a severe decrease in locomotor activity was observed on all animals within 1 hour after treatment. These findings disappeared on day-2 and no clinical signs were observed thereafter. (see: Table 2)
- Gross pathology:
- No gross change was observed at necropsy at end of the observation period.
- Other findings:
- There were no other findings.
Any other information on results incl. tables
Table 1: Mortality of female rates treated with tetrahydorfurfuryl alcohol
In the single dose oral toxicity test
Step |
Dose (mg/kg) |
Number of animals treated |
Number of animals that died |
Mortality |
Category (GHS) |
1 – 15 (days) |
|||||
1 |
2000 |
3 |
0 |
0* / 3** |
5 |
2 |
2000 |
3 |
0 |
0 / 3 |
*: Number of animals that died
**: Number of animals treated
GHS: Globally Harmonized Classification System
Table 2: Clinical signs of female rats treated with tetrahydrofurfuryl alcohol
in the single dose oral toxicity test
Step |
Dose (mg/kg) |
Findings |
Grade |
Day |
|||||
1 |
2 |
3 |
4 - 15 |
||||||
1 |
3 |
6(hrs) |
|||||||
1 |
2000 |
Number of animals examined |
3 |
3 |
3 |
3 |
3 |
3 |
|
(A) |
1 |
3 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
3 |
3 |
0 |
0 |
0 |
|||
(B) |
1 |
0 |
3 |
3 |
0 |
0 |
0 |
||
2 |
2000 |
Number of animals examined |
3 |
3 |
3 |
3 |
3 |
3 |
|
(A) |
1 |
3 |
0 |
0 |
0 |
0 |
0 |
||
3 |
0 |
3 |
3 |
0 |
0 |
0 |
|||
(B) |
1 |
0 |
3 |
3 |
0 |
0 |
0 |
A: Decreased locomotor activity
B: Hypeotonia
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An LD50 value of >2000 mg/kg bw is reported in a reliable study conducted according to current OECD guideline, but not in compliance with GLP.
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