Registration Dossier

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Administrative data

Description of key information

Bismuth metal is not considered to be irritating to skin or to the eye.

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)

Additional information

According to Annexes VII and VIII, points 8.1.1 and 8.2.1 of Regulation No 1907/2006 information on skin and eye irritation (in vitro or in vivo) of substances shall be provided. In addition, Annex XI specifies rules for adaptation of the standard testing requirements. Point 1.5 of Annex XI permits read-across from substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

This read-across concept is applicable to bismuth metal considering the physicochemical properties.

Taking the water solubility data in account bismuth metal was determined to be only slight soluble in water. The same test result was obtained for dibismuth trioxide.

The pH of a saturated aqueous solution of both bismuth metal and dibismuth trioxide has been determined at 6 (see section 4.8 of the technical dossiers, water solubility, k_Paulus_2010), which can be regarded as equivalent considering typical measurement variability. Therefore, the anticipated nature and severity of effects is expected to be comparable among bismuth metal and dibismuth trioxide. Read-across from dibismuth trioxide is thus considered feasible.

Tests on skin and eye irritation are available for dibismuth trioxide. According to the test results, this substance do not fulfil the criteria for classification as irritating to skin or eye.

Based on the above considerations, bismuth metal is proposed to be unclassified by read-across, which is therefore a conservative approach. In conclusion, since at least one of the criteria for adaptation of testing requirements specified by column 2 of Annexes VII and VIII, points 8.1 and 8.2 are fulfilled, any further testing is considered to be scientifically unjustified.

Justification for classification or non-classification

The results of an available in vitro skin irritation study (human skin model) with dibismuth trioxide indicate that bismuth is not irritating to skin by read across. Based on experimental results on a similar substance utilised by read across, bismuth metal requires no classification as irritating to skinaccording to regulation (EC) No.: 1272/2008.

Results of an available in vivo eye irritation study (rabbits) with dibismuth trioxide indicate that bismuth is not irritating to eyes by read across. Based on experimental results on a similar substance utilised by read across, bismuth metal requires no classification as irritating to eyes according to regulation (EC) No.: 1272/2008.

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