Registration Dossier
Registration Dossier
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EC number: 223-339-8 | CAS number: 3844-45-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The 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 green coloration of the urine of experimental animals in the acute toxicity study (BASF 1982). 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, 1980 and Brown 1980).
High oral doses cause diarrhea as the presence of an ionic, water soluble substance results in water retention in the large intestine.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The substance is of high solubility in water (5.9 g/L) and not surface active. Its high molecular weight of 792,8 g/mol and the negative n-octanol/water partition coefficient (log Pow < -4) 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 solubility in octanol was 0.004 mg/L indicating 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.
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