Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute Toxicity of Zirconium, Columbium, Strontium, Lanthanum, Cesium, Tantalum and Yttrium.
Author:
Cochran K W, Doull J, Mazur M & DuBois K P
Year:
1950
Bibliographic source:
Archive of Industrial Hygiene and Occupational Medicine 1:637-650
Reference Type:
secondary source
Title:
Patty's Industrial Hygiene and Toxicology Third Revised Edition
Author:
Clayton
Year:
1981
Bibliographic source:
Patty's Industrial Hygiene and Toxicology Third Revised Edition, Clayton GD, Clayton FE (ed.), John Wiley & Sons, 1981, p1906-1914
Reference Type:
secondary source
Title:
Metal Toxicity in Mammals 2, chemical Toxicity of Metals and Metalloids
Author:
Venugopal B & Luckey T
Year:
1978
Bibliographic source:
Ch. 5, pg. 231
Reference Type:
secondary source
Title:
The Merck Index 14th Edition An Encyclopedia of Chemicals, Drugs and Biologicals
Author:
O'Neil M (ed), Heckelman P E, Kock C B, Roman K J, Kenny C M & D'Arecca M R
Year:
2006
Bibliographic source:
Merck Research Laboratories Division of Merck & Co., Inc., Whitehouse Station, NJ, USA Pg. 9054

Materials and methods

Principles of method if other than guideline:
Test guidelines not mentioned in the literature.
GLP compliance:
not specified
Test type:
other: Not reported

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Adult
- Weight at study initiation: 200-300 g
- Diet (e.g. ad libitum): Purina chow given ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Maintained in an air conditioned room.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
Single dose
Details on study design:
Animals were observed for 10 days. A preliminary study was carried out for 30 days to determine an observation period.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 8 000 mg/kg bw
Based on:
test mat.
Other findings:
No significant observations were made over the 10 day period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tantalum oxide was recorded to have an LD0 of >= 8000 mg/kg after a single dose was administered to rats.
Executive summary:

Tantalum oxide was administered orally to rats in an acute toxicity study. There are limited methodological details provided. No standard guideline procedure was mentioned. The LD₀ was recorded as >= 8000 mg/kg of tantalum oxide, which is above the limits of classification. Tantalum oxide therefore does not require classification according to Regulation (EC) No.1272/2008.