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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1992-01-16 to 1992-01-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987-02-24
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 1991-07-25
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
potassium vanadium trioxide
IUPAC Name:
potassium vanadium trioxide
Constituent 2
Reference substance name:
Potassium vanadium trioxide
EC Number:
237-388-8
EC Name:
Potassium vanadium trioxide
IUPAC Name:
237-388-8
Constituent 3
Reference substance name:
13769-43-2
Cas Number:
13769-43-2
IUPAC Name:
13769-43-2
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Potassium metavanadate
- Physical state: light-grey, solid amorphous fine powder
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS - Sprague-Dawley/ Tif:RAI f (SPF)
- Source: Lippische Versuchstierzucht, HAGEMANN GmbH, D-4923 Extertal 1
- Age at study initiation: approximately. 40 - 60 days
- Weight at study initiation: 155 - 180 g
- Fasting period before study: feeding was discontinued approximately 16 hours before administration. Only tap water was offered ad libitum.
- Housing: granulated textured wood was used as bedding material for the cages (Granulat Typ A2, supplier: Messrs. BRANDENBURG, Inh. H. Brandenburg, D-2849 Goldenstedt). On the day of treatment and during the observation period, the animals were kept in groups of 2 - 3 in MAKROLON cages (type III).
- Diet: standardized diet for rats ALTROMIN 1324 (supplied by : ALTROMIN GmbH, D-4937 Lage/Lippe)
- Water (ad libitum): tap water
- Quarantine period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Relative humidity: 60% ± 20% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 0.8% aqueous hydroxypropyl-methylcellulose gel
Details on dermal exposure:
TEST SITE
- Area of exposure: the hair on the site of application was clipped with hair-clippers without causing injury approximately 24 hours before application. The site was situated on the animal's back between the fore and hind extremities and had an area of at least 5 x 6 cm (1/10 of body surface).
- Type of wrap if used: the test substance was applied to 8 layers of gauze and then to the application site. The patch was covered with a plastic sheet and secured with adhesive plaster.

REMOVAL OF TEST SUBSTANCE
- Washing: residual substance was removed with tepid tap water.
- Time after start of exposure: at the end of the exposure period

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the volume of application was 20 mL/kg bw. The dose interval factor: 1.25.

VEHICLE
- Potassium metavanadate was suspended in 0.8% aqueous hydroxypropyl-methylcellulose gel.
- Batch no.: MM 84097413B
Duration of exposure:
24 hours
Doses:
2000 and 2500 mg/kg bw
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed immediately, 5, 15, 30 and 60 minutes, as well as 3 hours, 6 hours and 24 hours after administration. During the follow-up period (at least 2 weeks) changes in skin and fur, eyes and mucous membranes, respiratory and circulatory, autonomic and central nervous system and somatomotor activity and behaviour pattern were observed at least once a day until all symptoms have subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on mortality were made at least once daily with appropriate actions taken to minimise loss of animals during the study. Individual body weights were recorded before administration of the substance, thereafter in weekly intervals up to the end of the study, and at death. Changes in weight were calculated and recorded when survival exceeds one day.
- Necropsy of survivors performed: yes; at the end of the experiments all surviving animals were sacrificed dissected and inspected macroscopically. All gross pathological changes were recorded. From animals which survive 24 hours or longer a microscopic examination of all organs which show evident lesions was performed. Autopsy and macroscopic inspection of the animals which died prematurely were carried out as soon as possible after exitus.
- Other examinations performed: the skin was observed for the development of erythema and oedema and was rated according to the Draize scale.
Statistics:
The LD50 could not be calculated because no mortality occurred.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 after 24 hours and 14 days
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 after 24 hours and 14 days
Mortality:
None of the animals died prematurely.
Clinical signs:
Under the present test conditions no local or systemic intolerance reactions were observed up to the highest tested dose-level of 2500 mg/kg bw by dermal administration to rats.
Body weight:
No inhibition of body weight gain was observed.
Gross pathology:
No pathological findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the EC-Regulation 1272/2008 and subsequent adaptations, the test item is not classifiedas as acute toxic via the dermal route.
LD50 (male rats) > 2500 mg/kg bw
LD50 (female rats) > 2500 mg/kg bw