Niobium

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07.08.2009-27.11.2009

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:

yes

Remarks:

Deviation from the study plan due to physical state , the applied doses deviate from the intended level of 2000 mg/kg bw (deviations for males: +5 to +9%; females:-0.2 to -2%). The deviation did not influence the quality or integrity of the present study.

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Niobium

EC Number:

231-113-5

EC Name:

Niobium

Cas Number:

7440-03-1

Molecular formula:

Nb

IUPAC Name:

Niobium

Constituent 2

Reference substance name:

Niobium Metal (Nb)

IUPAC Name:

Niobium Metal (Nb)

Test material form:

solid: compact

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: females: 9-10 weeks; males: 6-7 weeks
- Weight at study initiation: females: 201-212 g; males: 222-230 g
- Fasting period before study: none
- Housing: individdually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (ad libitum): ad libitum
- Water (ad libitum):ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 55+-10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12


IN-LIFE DATES: From: 2009-09-01 To: 2009-09-29

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: gauze-dressing and non-irritant tape


TEST MATERIAL
- For solids, paste formed: no

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

Statistics:

not applicable

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: None

Gross pathology:

None

Other findings:

Slight marks of pressure caused by the test item were noted in all males and females on the day of dosing. No signs of skin irritation were noted in any animal

Any other information on results incl. tables

Sex	Dose (mg/kg bw)	Number of animals tested / number of dead animals	LD50 (mg/kg bw)
Males	2000	5/0	> 2000
Females	2000	5/0	> 2000

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Under the conditions of the present study, single dermal application of niobium to rats at a dose of 2000mg/kg bw was associated with no signs of toxicity or mortality.
CLP: not classified