Registration Dossier

Administrative data

Description of key information

SKIN IRRITATION/CORROSION

Ditantalum pentaoxide was determined to be none irritating, according to the GLP compliant key study (Blanchard, 2000) which was conducted according to standardised guidelines; OECD 404, EU Method B.4 and EPA OPPTS 870.2500.

EYE IRRITATION

Ditantalum pentaoxide was determined to be none irritating, according to the GLP compliant key study (Blanchard, 2001) which was conducted according to standardised guidelines; OECD 405, EU Method B.5 and EPA OPPTS 870.2400.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN IRRITATION

The key study (Blanchard, 2000) is a GLP compliant study and was performed in compliance with the standardised guidelines; OECD 404, EU Method b. 4 and EPA OPPTS 870-2500, with a sufficient level of detail to assess the quality of the data. Three New Zealand White Rabbits were exposed to 0.5g of the test material for 4 hours. The no effects of irritation were observed over the 72 hour observation period, and thus the test material was deemed to be none irritating. 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).

EYE IRRITATION

The key study (Blanchard, 2001) is a GLP compliant study and was performed in compliance with the standardised guidelines; OECD 405, EU Method B. 5 and EPA OPPTS 870-2400, with a sufficient level of detail to assess the quality of the data. Three New Zealand White Rabbits were exposed to 100 mg of the test material placed in the lower eye lid. The no effects of irritation were observed over the 72 hour observation period, and thus the test material was deemed to be none irritating. 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).

Justification for selection of skin irritation / corrosion endpoint:

Study conducted in accordance with a recognised 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 eye irritation endpoint:

Study conducted in accordance with a recognised 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 classification or non-classification

SKIN IRRITATION

The skin irritation study indicates that exposure to the test material does not cause any effects which requires classification. Therefore the material does not require classification in line with Regulation (EC) No. 1272/2008 or Directive 67/548/EEC.

 

EYE IRRITATION

The eye irritation study indicates that exposure to the test material does not cause any effects which requires classification. Therefore the material does not require classification in line with Regulation (EC) No. 1272/2008 or Directive 67/548/EEC.