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Toxicological information

Acute Toxicity: dermal

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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:
other: 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:
yes
Remarks:
Before: The test item will be applied at a single dose, uniformly over an area which will be approx. 10% of the total body surface. The test item will be held in contact with the skin by a dressing throughout a 24- hour period. The dressing will consist o
GLP compliance:
yes (incl. QA statement)
Limit test:
yes

Test material

Constituent 1
Chemical structure
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:
24hs
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:
no significant findings
Body weight:
The body weight development of all male and female animals was within the
expected range
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  > 2000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
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.