Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-05-13 to 2003-07-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented, scientifically sound study that was conducted in accordance to GLP and OECD Guideline 423; limit test.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tungsten oxide blue
- Molecular formula (if other than submission substance): WO
- Physical state: Blue to black powder
- Analytical purity: 99.9%
- Purity test date: 2003-04-15
- Stability under test conditions: 5 years
- Storage condition of test material: Ambient temperature
- Other: Solubility in water- 118 mg/L at 20 degrees C
- pH: 6.9

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)IGS BR
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: Approximately 8 weeks at the time of administration
- Weight at study initiation: 183-194 g
- Fasting period before study: Yes; the feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.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: Housed singly in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids.
- Diet: Ad libitum (Altromin 1324 forte, gamma irradiated with 25 kGy 60 Co)
- Water: Ad libitum (tap water from an automatic watering system)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 22.0 degrees C (continuous control and recording)
- Humidity (%): Average of 59.6% (continuous control and recording)
- Air changes (per hr): 12/hr
- Photoperiod (hrs dark / hrs light): 12 dark/12 light (artificial light from 6 am to 6pm)

IN-LIFE DATES: From: 2003-05-13 To: 2003-05-28

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.1% CMC and 0.1% "Tween 80" (from Merck) in deionised 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 of the test substance in the vehicle. Suspensions were prepared freshly before administration and were administered within 15 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
No. of animals per sex per dose:
3 females for each step (6 animals total)
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: determined before administration, 7 days and 14 days post administration. Body weight gain was calculated for each week of the study, between 0 and 7 days post administration and 7 and 14 days post administration.
- Necropsy of survivors performed: Yes; including gross pathological exmanination.
Statistics:
no data

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No severe toxic effects were present after a single dose of 2000 mg/kg of the test substance.
Mortality:
None
Clinical signs:
All animals were affected. The findings, with an onset shortly after the administration and lasting until a maximum of 6 hours post administration included the piloerection and hunched posture, which was attributed to discomfort.
Body weight:
All animals gained weight in both weeks post administration.
Gross pathology:
All animals were normal at the necropsy 14 days post administration.
Other findings:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No severe toxic effects of Tungsten oxide blue 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.