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Description of key information

On the basis of the available experiments a clear conclusion about bioaccumulative potential cannot be reached.

Key value for chemical safety assessment

Additional information

Basic Blue 140 is a dark blue/purple organic powder; it is primarily manufactured/used as an aqueous solution.

Basic Blue 140 is not toxic/harmful for short-term exposures and it is not skin/eye irritating. It is not able to cause an allergic skin reaction. No CMR activity has been never been reported and has not be observed in specific experiments performed. Therefore, mechanisms of bioactivation leading to adverse effects are not expected to occur.

 

Specific studies or specific literature data on toxicokinetics and metabolism are not available, thus available information about the substance has been taken into account, avoiding further tests.

 

Because of the molecular size and the hydrophilic character of Basic Blue 140, dermal absorption is expected to be negligible. The skin metabolites simulation proposes possible oxidation and methylation reactions in different points of the compound.

Based on the available information, a substance acute dermal toxicity potential is not suspected. Furthermore, the substance gave negative results in skin sensitisation potential investigation, thus it is considered as not able to cause an allergic response in susceptible individuals, after exposure via the skin.

 

Because of the physical state, trade form and physicochemical characteristics, inhalation is not an appropriate route of exposure; furthermore, considering the molecular size and the hydrophilic character of Basic Blue 140, dermal absorption is expected to be negligible.

 

No abnormalities were recorded in the acute toxicity studies available, by oral route.

During the subacute oral test, the structural analogous Similar Substance 02 treatment did not produce changes detected in functional observation of animals. Changes connected with colour of test substance were found in animals at all dose levels. Presence of blue pigment was not accompanied by inflammatory or degenerative changes; furthermore, dysfunction of organs/tissues caused by the presence of pigment was not demonstrated. Due to water solubility it is possible that pigment will gradually disappear from kidneys.

The read across approach has been further detailed in the report attached to the IUCLID section 13.

 

Based on the chemical structure, the substance is expected to be stable and not easily metabolized. The presence of coloured stool and colouration of organs observed in systemic experiments let to expect that the scaffold chemical structure was not significantly modified by transformation; colour proves that the conjugation is not completely interrupted.