Dibismuth trisulphide

Endpoint summary

Description of key information

Skin irritation in vitro:
In this in vitro skin irritation test in the EPISKIN model with test item dibismuth trisulphide the results indicated that the test item is considered to be a non-irritant (NI) [UN GHS: No Category].
Eye irritation in vivo:
In conclusion, test item Dibismuth trisulfide (Bi2S3) applied to the rabbits' eye mucosa, caused slight conjunctival irritant effects, fully reversible
within 24 hours.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category.

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/corrosion

In an in vitro skin irritation test using the EPISKIN model, the test item dibismuth trisulfide did not show significantly reduced cell viability in comparison to the negative control. Test item viability results were above 50% when compared to the viability values obtained from the negative control.

Positive and negative controls showed the expected cell viability values within acceptable limits. The experiment was considered to be valid.

The results obtained from this in vitro skin irritation test, using the EPISKIN model, indicated that the test item Dibismuth trisulfide reveals no skin irritation potential under the utilised testing conditions. According to the current OECD Guideline No. 439, dibismuth trisulfide is considered a non-irritant to skin and is therefore not classified. No further in vivo test has to be performed.

Eye irritation in vitro

In an in vitro eye corrosives and severe irritants study, using the Isolated Chicken Eyes model with Dibismuth trisulfide, no ocular corrosion or

severe irritation potential was observed. Thus, according to the guideline OECD 438, Dibismuth trisulfide cannot be classified as an ocular

corrosive or severe eye irritant. Furthermore, the results suggest that the test item was slightly irritating. However, in relation to the irritation

potential, a further in vivo rabbit study is required for classification.

Eye irritation in vivo

According to OECD guideline 405 the eye irritation of dibismuth trisulfide was determined. In conclusion, test item dibismuth trisulfide applied to the rabbits' eye mucosa, caused slight conjunctival irritant effects, fully reversible within 24 hours.

According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.

According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category.

Justification for selection of skin irritation / corrosion endpoint:
Most reliable study

Justification for selection of eye irritation endpoint:
Most reliable study

Justification for classification or non-classification

Based on skin irritation data available for dibismuth trisulfide no classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.

According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified as irritant to eyes and has no obligatory labelling requirement for eye irritation. According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category.