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Description of key information

Not expected as bioaccumulative

Key value for chemical safety assessment

Additional information

Direct Blue 199 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 in literature 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 Direct Blue 199, dermal absorption is expected to be negligible. The skin metabolites simulation proposes possible oxidation 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 and the characteristic particle size distribution, inhalation is not an appropriate route of exposure; furthermore, considering the molecular size and the hydrophilic character of Direct Blue 199, 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 test substance 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.

 

Based on the chemical structure, the substance is expected to be stable and not easily metabolized. The sulfonation degree contributes to increased solubility and to increased detoxification. 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.

On the basis of the available experiments a clear conclusion about bioaccumulative potential cannot be reached. The persistence of the colouration is mammalian tissue after a repeated dose toxicity test, involving appreciable concentrations, cannot be considered as a proof of bioaccumulative character of a substance. Considering the sulfonated chemical structure and the fact that it has a negative log Kow and can be described by a molecular weight of 858 g/mol, a significant bioaccumulative character is unlikely.