Registration Dossier

Administrative data

Description of key information

ACUTE ORAL TOXICITY

The oral toxicity of ditantalum pentaoxide has been recorded in key literature to be LD0 ≥ 8000 mg/kg in rats (Cochran 1950).

ACUTE INHALATION TOXICITY

The acute inhalation toxicity of ditantalum pentaoxide was determined to be LD0 > 3.89 mg/l  in the key study Wilcox (2001), according to the following standardised guidelines: OECD 403, EPA OPPTS 870.1300, EEC (Annex II, point 5.2.3) and J-MAFF.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The key paper of Cochran (1950) provided sufficient information to address this endpoint and was assessed to be reliable with restrictions (2, Klimisch 1997)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
A reliable Klimisch 1 study is available to address this endpoint, along with 2 supporting studies. The quality of the database is high.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

 ACUTE ORAL TOXICITY

Cochran (1950) showed that the LD₀ of the test material is above the limits of classification. The publication provides data which is of a good standard and was assigned a reliability score of 2 using the principles for assessing data quality as set out in Klimisch (1997). Furthermore the study was cited by O´Neil (2006), Clayton (1981) and Venugopal (1978), which are given as secondary source.

 

ACUTE INHALATION TOXICITY

The key study (Wilcox, 2001) was conducted in line with GLP and standardized guidelines with a sufficient level of detail to assess the quality of the study. Five male and five female Sprague-Dawley rats were exposed to the test material as an aerosol at the maximum practical concentration for 4 hours. The LD₀ was determined to be >= 3.89 mg/l, as no mortalities were seen at the maximum concentration. The study was performed to a good standard and was assigned a reliability score of 1 using the principles for assessing data quality as set out in Klimisch (1997).

 

Nemetschek-Gansler (1975) and ACGIH (2001) have been provided as supporting data. They show that no morphological changes occur in the lungs within a realistic exposure level. They have been assigned reliability scores of 2 and 4 respectively, according to Klimisch (1977).

 

Justification for selection of acute toxicity – oral endpoint

No single study was considered robust enough to be considered as the key study. Therefore a weight of evidence approach was used.

 

Justification for selection of acute toxicity – inhalation endpoint

Study conducted in accordance with a recognized OECD guideline and in accordance with GLP in a certified laboratory. Study is assigned a reliability score of 1 in accordance with Klimisch (1997).

 

Justification for selection of acute toxicity – dermal endpoint

Testing via the dermal route was not conduced as the inhalation route was considered a more likely route of exposure.

Justification for classification or non-classification

ACUTE ORAL TOXICITY

The data indicate that exposure to the test material does not result in effects which require classification. Therefore the material does not require classification in line with Regulation (EC) No. 1272/2008 or Directive 67/548/EEC.

ACUTE INHALATION TOXICITY

The data indicate that exposure to the test material does not result in effects which require classification. Therefore the material does not require classification in line with Regulation (EC) No. 1272/2008 or Directive 67/548/EEC.