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Registration Dossier
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EC number: 215-231-4 | CAS number: 1314-35-8
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-07-02 to 2002-08-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented, scientifically sound study that was conducted in accordance with GLP and OECD Guideline 423, limit test.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Tungsten trioxide
- EC Number:
- 215-231-4
- EC Name:
- Tungsten trioxide
- Cas Number:
- 1314-35-8
- Molecular formula:
- O3W
- IUPAC Name:
- trioxotungsten
- Details on test material:
- - Name of test material (as cited in study report): Tungsten oxide (WO3)
- Physical state: Yellow to greenish powder
- Analytical purity: 99.88%
- Purity test date: 2002-05-28
- Stability under test conditions: 5 years
- Storage condition of test material: Ambient temperature, dry
- Melting Point: Approx. 1473 degrees C
- pH: 6.1 (aqueous suspension, 100 g/L)
- Solubility in water: <10 mg/L WO3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)IGS BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River WIGA
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: 166-167 g (females), 195-201 (males)
- Fasting period before study: Yes; the feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
- Diet: Altromin 1324 forte, gamma irradiated with 25 kGy60Co, ad libitum.
- Water: Tap water from an automatic watering system, ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22.2 °C
- Humidity (%): Average of 64.7%
- Air changes (per hr): 12/hr
- Photoperiod (hrs dark / hrs light): 12 dark/12 light (6 am to 6 pm)
IN-LIFE DATES: From: 2002-07-02 To: 2002-07-17
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- DOSE VOLUME APPLIED: 10 mL /kg body weight
DOSAGE PREPARATION: Doses of 2000 mg/kg body weight were prepared as suspensions in deionised water. Suspensions were prepared freshly before administration and were administered within 5 minutes after the preparation.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As requested by the sponsor - Doses:
- 2000 mg/kg body weight (in two steps)
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical observations- 0-0.5, 0.5-1, 1-2, 2-4, and 4-6 hours after administration and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
- Body weights- before administration, day 7, and day 14 post administration. Bodyweight gain was calculated for each week of the study, i.e. between 0 and 7 days post administration and 7 and 14 days post administration.
- Necropsy of survivors performed: Yes - Statistics:
- no data
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No toxic effects were present after a single dose of 2000 mg/kg of the test substance.
- Mortality:
- None
- Clinical signs:
- other: All animals were normal during the whole observation period.
- Gross pathology:
- All animals were normal at the necropsy, 14 days post administration.
- Other findings:
- There was no significant sex difference in the response to the test substance at 2000 mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No toxic effects of the test substance were noted by signs in life and post mortem. No mortality occurred. An LD50 of > 2000 mg/kg body weight for rats was established for the test substance.
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