Diniobium pentaoxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 august 2009 - 29 september 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diniobium pentaoxide

EC Number:

215-213-6

EC Name:

Diniobium pentaoxide

Cas Number:

1313-96-8

Molecular formula:

Nb2O5

IUPAC Name:

diniobium(5+) pentaoxidandiide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female
The female animals were nulliparous and non-pregnant.
Body weight at the beginning of the study: females: 201 - 205 g, males 216 – 225 g
Age at the beginning of the study: females: 9 - 10 weeks, males: 6 - 7 weeks old
Number of animals: 5 male and 5 female
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.

Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 0654)
- Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiologically controlled at frequent intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 040509)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Application
The test item was applied at a single dose, uniformly over an area which was approx. 10% of the total body surface.
Except for animal no. 22, which lost its dressing overnight, the test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: clinical examinations were made several times on the day of dosing, thereafter once daily

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: no significant findings

Gross pathology:

no specific gross pathological changes were recorded for any animal

Any other information on results incl. tables

Dose unit	Number of animals investigated	Number of intercurrent deaths	LD50
2000 mg/kg bw	5 female	0	> 2000 mg/kg bw
2000 mg/kg bw	5 male	0	> 2000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

Under the conditions of the present study, single dermal application of the test item Diniobium Pentaoxide to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.