Tungsten oxide

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2002-08-21 to 2002-11-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The reliability of this study for the substance tested is a K1, but in application of read-across to a different substance ECHA’s guidance specifies that the score can be a maximum of K2. Due to similar water solubility, in vitro bioaccessibility in synthetic alveolar, lysosomal, and interstitial fluids simulating inhalation exposure, and available toxicity data for the target (tungsten oxide) and source (WO3) substances, the resulting toxicity potential would also be expected to be similar so read across is appropriate between these substances. In addition, read across is appropriate for this endpoint because the classification and labeling is the same for the source and target substances, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, sufficiently similar or more conservative for the target substance. For more details refer to the attached description of the read across approach on Annex 3 in the CSR.

Justification for type of information:

1. HYPOTHESIS FOR THE CATEGORY APPROACH: The hypothesis is that properties are likely to be similar or follow a similar pattern because of the presence of a common metal ion, in this case tungstate.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES):
Source: Tungsten trioxide
Target: Tungsten oxide
3. CATEGORY APPROACH JUSTIFICATION: See Annex 3 in CSR
4. DATA MATRIX: See Annex 3 in CSR

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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)
- Supplier: Sponsor
- 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: Room temperature
- pH: 6.1 (aqu. suspension, 100 g/L)
- Solubility in water: < 10 mg/L WO3
- Melting point: Ca. 1473 degrees C

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)IGS BR, Sprague Dawley, SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River WIGA, Germany
- Age at study initiation: Approximately 9 weeks at time of administration
- Weight at study initiation: 305-336g (males), 207-225g (females)
- Housing: Housed singly in Makrolon cages type III (39 cm x 23 cm x 18 cm)
- Diet: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co - ad libitum (withheld during the exposure)
- Water: Tap water from an automated watering system - ad libitum (withheld during the exposure)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Target of 22 °C
- Humidity (%): Target of 50%
- Air changes (per hr): 12/hour
- Photoperiod (hrs dark / hrs light): 12 dark/12 light (6 am to 6 pm)

IN-LIFE DATES: From: 2002-08-21 To: 2002-09-25

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: TSE, Technical & Scientific Equipment- article no. 504101. It consisted of a two chamber system. The apparatus was 30 cm in diameter and 27 cm in height, resulting in a total volume of 19 litres.
- Exposure chamber volume: 19 L
- Method of holding animals in test chamber: Trapped in outer chamber with opening to exposure chamber
- Source and rate of air: Obtained from a central pressure pump, 1836 L air/dust per hour
- System of generating particulates/aerosols: RBG 1000 dust generator
- Method of particle size determination: Cascade impactor (Berner-Impaktor Type LP14/0,06/2)
- Temperature, humidity, pressure in air chamber: 21-23 °C, 12.7 to 16.0 %, approx 3 bar.

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric analysis- dust was collected 9 times during the exposure period in plastic pipette-tips filled with cotton wool, which were inserted into the inhalation facility through a separate hole between two inhalation tubes.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 64% of the mass was in the fraction with a diameter of less than 5 micrometers, the size distribution did not exactly follow a log-normal distribution but had an additional fraction of particles larger that 16 micrometers.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD=3.7 micrometers, GSD= 2.3

Analytical verification of test atmosphere concentrations:

yes

Remarks:

4.47- 5.87 mg/L (detected 9 times)

Duration of exposure:

ca. 4 h

Concentrations:

- Mean concentration= 5.36 mg/L

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations- 1, 2, 3, 4, 5, and 6 hours after the start of the exposure, and then at least once a day for a total of 2 weeks.
- Body weight:
Individual- before administration, day 7, day 14, and post mortem
Body weight gain was calculated for each week of the study, 0 and 7 days post administration, 7 and 14 days post administration.
- Necropsy of survivors performed: Yes; in attempt to identify the target organs

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.36 mg/L air (nominal)

Exp. duration:

4 h

Mortality:

- All animals survived until the end of the study.

Clinical signs:

other: - Immediately after exposure the fur at the head of all animals was stained yellow (due to sedimentation of the test substance). - Three animals showed chromodacryorrhoea for a short time after the exposure. This is a sign of general malaise and may be c

Body weight:

- The mean body weights at the end of the exposure were 319 g for males and 216 g for females. The mean body weight gain in the first week after the exposure was 47 g for males and 16 g for females. In the second week males gained 43 g, females 14 g.
- No animal lost weight during the study.

Gross pathology:

- Nothing abnormal was seen in any of the animals.

Other findings:

- Other observations: No sex differences could be established from the results of this study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The inhalation exposure of rats to Tungsten Oxide (WO3) at a concentration of 5.36 mg/L only produced signs of general malaise a short time after the exposure. The animals recovered within one hour and no further adverse effects were observed. The LC50, for four hours of exposure to tungsten trioxide (WO3) for male and female rats was found to be greater than 5.36 mg/L air.

Executive summary:

No acute inhalation toxicity data of sufficient quality are available for tungsten oxide (target substance).  However, acute inhalation toxicity data are available for tungsten trioxide (source substance), which are used for read-across. Due to similar water solubility, in vitro bioaccessibility in synthetic alveolar, lysosomal, and interstitial fluids simulating inhalation exposure, and available toxicity data for the target and source substances, the resulting toxicity potential would also be expected to be similar, so read-across is appropriate between these substances. In addition, read-across is appropriate for this endpoint because the classification and labeling is the same for the source and target substances, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, sufficiently similar. For more details, refer to the read-across category approach description in the Category section of this IUCLID submission or Annex 3 of the CSR.