Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium

Endpoint summary

Description of key information

The test substance is taken up by the body after ingestion at a very low extent and only after high doses (eg 1900 mg/kg bw) as indicated by the torquois coloration of the urine of expermental animals in the acute toxicity study.

It is eliminated mainly via the bile and to a lesser extent via the urine. At low doses with 14-C-labelled material, absorption is generally below the limit of detection (Phillips et al, 1980 and Brown et al, 1980).
High oral doses cause diarrhea as the presence of an ionic, water soluble substance results in water retention in the large intestine.

No permeation through skin or percutaneous absorption has been revealed.

References:

Phillips et al, 1980. The Metabolic Disposition of 14C-Labelled Green and Brilliant Blue FCF in the Rat, Mouse and Guinea Pig. Fd. Cosmet. Toxicol. 18, 7-13.

Brown et al, 1980. Synthesis of 14C-labelled FD&C Blue No.1 (Brilliant Blue FCF) and its intestinal absorption and metabolic fate in rats. Fd. Cosmet. Toxicol. 18, 1-5.

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Additional information

Since no studies are available for the target substance, Similar Substance 1 has been considered to complete the toxicokinetics, metabolism and distribution behaviour of Acid Blue 9 ammonium salt. Justification for Read Across is given in Section 13 of IUCLID.

The substance is of high solubility in water and not surface active. Its high molecular weight of > 500 g/mol and the negative n-octanol/water partition coefficient are not favourable for transfer across biological membranes. The substance is a non-volatile triphenylmethane dye that decomposes prior to melting at temperatures above 250°C. The low solubility in octanol indicates no potential for accumulation in fat.

Intraperitoneal injection in mice resulted in blue coloration of the whole body. Coloration disappeared mainly via the bile, at a later time point also via the urine (Gross et al 1961). Gross et al also observed transient slight urine coloration after oral application of high doses.

Intravenous application resulted in more than 91% elimination via the bile within 4 hours. Within the first 30 minutes, 80% of the colorant were already eliminated (Iga 1971).

In both studies, the substance was analysed via its colour (Absorption at 618 nm). This indicates that the substance is either not metabolized or that metabolites have the intact chromophore.

Studies with 14C-labelled test substance and gavage dosing showed almost complete direct elimination via the feces within 72h; more than 70% were eliminated during the first 24h (Philipps 1980, Brown 1980).

Urinary, faecal and pulmonary excretion of radioactivity after oral administration to bile-duct ligated rats were 2.02, 97.28 and 0.01% of the administered dose, respectively (Brown 1980). Radioactivity recovered from internal organs represented 0.02% of that administered dose. Total recovery of administered radioactivity was 99.38%.

No placental transfer was observed if pregnant rats were dosed by gavage on gestation day 8 (Phillips 1980). Philips et al reported the same results for rats, mice and guinea pigs.

No permeation through skin or percutaneous absorption has been rported by a study according to Draft OECD Guideline (1996). Six cells were used. The diffusion chambers had a diameter of 1.135 cm and a volume of 1 ml in the donor chamber. Saline adjusted to pH 3.0 was used as receptor medium and pumped through the cells with a flow rate of 1-2 ml/hour. The temperature in the incubator was 32 ºC. After filling the donor chambers with test material were covered with Parafilm® for 30 minutes and then the test substance removed and the surface washed 3 times with shampoo. The donor chambers were then filled with saline and receptor medium collected at 0.5, 1, 2, 4, 6, 8, and 24 hours. The samples were analysed by HPLC with a detection limit of 150 ng/ml. After the end of study mass balance was made by analysing the amount of test substance bound to the skin and in the washings. The mean recovery was 93.3% ± 4.05% (SD) in experiment I, and 115,2% ± 6.43% (SD) in experiment II. Appropriate controls were included.