1,4-bis(mesitylamino)anthraquinone

Endpoint summary

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Additional information

Toxicokinetic behavior (absorption – distribution – metabolism – excretion) of Solvent Blue 104 has not been investigated experimentally in detail.

However, taking into account the physico-chemical properties and the toxicological test results, some conclusions on the toxicokinetics of Solvent Blue 104 can be drawn.

Absorption: a prerequisite for a relevant absorption is that the substance can be dissolved in either aqueous (e.g., gastrointestinal fluid, blood plasma, sweat) or lipophilic (e.g., lipoproteins, lipid membranes, triglycerides) media or in both. Solvent Blue 104 has only a low solubility in water and n-octanol. Therefore, it is unlikely that Solvent Blue 104 becomes systemically bioavailable after oral, dermal or inhalation exposure in relevant amounts.

Based on the acute oral toxicity, acute dermal toxicity, repeated dose toxicity and reproduction/developmental toxicity screening studies, which did not reveal any systemic effects that would indicate that the pigment had entered the body, no significant absorption via the gastrointestinal tract has to be assumed.

Solvent Blue 104 does not have particular skin or eye irritating or skin sensitizing properties that would imply a dermal absorptive potential. In addition, in the acute dermal toxicity study no signs of absorption, systemic toxicity and dermal irritation were observed.

In the unlikely event of exposure to aerosolized pigment in respirable form, the substance is considered likely to behave like an inert dust. Therefore, the deposited pigment particles will mostly be cleared from the lung via the mucocilliary transport. As the pigment will not dissolve in the lung surfactant, the only way the pigment can enter the body is via phagocytosis of pigment particles by lung macrophages followed by migration of the macrophages into the interstitium and into the draining lymph nodes. However, the internal dose delivered via this mechanism can be considered negligible.

Distribution:the repeated dose toxicity and reproduction/developmental toxicity screening studies did not indicate any relevant histopathological changes in any of the investigated organs. This may indicate that either the pigment does not affect special organs as targets, i.e., is non-toxic, or is not distributed within the body in significant amounts. As indicated above, the physico-chemical parameters of the pigment support the conclusion that the pigment is not absorbed into the body and thus does not become systemically available. There were also no other signs of deposition of the pigment in any organ including excretory organs, like the kidney, indicating that even exposure to high doses of the pigment does not lead to bioaccumulation in special compartments of the body. 

Metabolism: since the dissolution of the substance in cellular fluid or cellular membranes is a prerequisite for its metabolism, it is unlikely that the insoluble pigment becomes accessible for metabolizing systems in relevant amounts. The results of the mutagenicity tests provide useful indications for qualitative consideration of the metabolic fate of Solvent Blue 104. In the mutagenicity tests, the pigment proved to be practically non-toxic and non-mutagenic in the absence as well as in the presence of an exogenous metabolizing system, indicating that the pigment is not converted into toxic or genotoxic metabolites. This conclusion is also supported by the lack of any morphological and histopathological changes of organs involved in xenobiotic metabolism, such as the liver, in the repeated dose toxicity study.

Excretion: the available data indicate that Solvent Blue 104 is not absorbed into the body. In line with this conclusionthe repeated dose toxicity and reproduction/developmental toxicity screening studies did not indicate morphological or histopathological effects of the pigment on organs involved in excretion of chemicals from the body, such as the kidney. There was no indication that the substance was present in the urine.