Testing Information

Testing Status of Agents at NTP

CAS Registry Number: 129-17-9 Toxicity Effects

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Selected toxicity information from HSDB, one of the National Library of Medicine's databases. 1

Names (NTP)

  • Sulfan blue
  • C.I. ACID BLUE 1 SODIUM SALT (9CI)

Human Toxicity Excerpts

  • DRUG HYPERSENSITIVITY ON PATIENTS BEING TESTED BY SKIN-PRICK & RECEIVING LYMPHOGRAM. [KALIMO K, SAARNI H; RADIOLOGY 141 (2): 365 (1981)]**PEER REVIEWED**
  • A CASE OF AN ALLERGIC REACTION TO PATENT BLUE VIOLET DYE USED FOR THE PURPOSE OF LYMPHANGIOGRAPHY IS REPORTED. SYMPTOMS WERE URTICARIAL REACTION, EDEMA OF THE EYELIDS & LIPS, AND HYPOTENSION. [HIETALA SO ET AL; LYMPHOLOGY 10 (3): 158 (1977)]**PEER REVIEWED**
  • Immediate reactions to patent blue dye /is presented/. [Kalimo K, Saarni H; Contact Dermatitis 7 (3): 171-2 (1981)]**PEER REVIEWED**
  • sensitivity to patent blue dye during skin prick testing and lymphography. A retrospective and prospective study. [Kalimpo K et al; Radiology 141 (2): 365-7 (1981)]**PEER REVIEWED**
  • It was noted that: a few minutes after sc injection of patent blue dye, two patients developed acute uticaria with a characteristic blue green hue. [vanHecke E et al; Hautarzt 34 (12): 638-9 (1983)]**PEER REVIEWED**
  • allergic reaction to the food dye patent blue. [Chadwick BL et al; Br Dent J 168 (10): 386-7 (1990)]**PEER REVIEWED**
  • Allergic reactions during lymphography are uncommon, usually minor and difficult to attribute to a single agent because of the common practice of mixing patent blue dye and local anaesthetic before injection. A case is presented where injection of patent blue dye alone was followed by a generalized urticaria, swelling and constriction in the throat and difficulty breathing. [Barber CJ; Clin Radiol 40 (6): 631 (1989)]**PEER REVIEWED**

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Non-Human Toxicity Excerpts

  • GROUP OF 10 MALE & 10 FEMALE 5-WK-OLD WISTAR RATS RECEIVED WEEKLY SC INJECTIONS OF 0.5 ML OF 4% SOLN OF BLUE VRS (PURITY NOT GIVEN) IN ISOTONIC SALINE FOR 45 WK (TOTAL DOSE 900 MG). ... 2 FEMALES DEVELOPED RHABDOMYOSARCOMAS IN AREA OF INJECTION SITE. IN 20 CONTROL ANIMALS /8 ALIVE @ 71 WK/, NO INJECTION-SITE TUMORS SEEN. [IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work)., p. V16 166 (1978)]**PEER REVIEWED**
  • SHELL OR CARWORTH FARM E ALBINO RATS OF BOTH SEXES, WEIGHING 100-150 G, WERE GIVEN TWICE WEEKLY SC INJECTIONS OF EITHER 0.5 ML OF 2% SOLN (20 RATS) OR 1 ML OF 1% AQ SOLN (65 RATS) OF BLUE VRS (82% PURE) FOR 55 OR 72 WK, RESPECTIVELY. 6 OUT OF 19 & 8/60 RATS DEVELOPED SARCOMAS AT SITE OF REPEATED INJECTIONS. [IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work)., p. V16 166 (1978)]**PEER REVIEWED**
  • TWENTY RATS RECEIVED TWICE WEEKLY SC INJECTIONS OF 0.5% ML OF A 2% AQ SOLN OF THE DYE FOR 65 WK, BUT INJECTIONS WERE DISTRIBUTED AMONG 4 SC SITES IN TURN (DORSAL TO THE SCAPULAE & IN THE LUMBAR REGION). AT 81 WK, NO SARCOMAS OBSERVED IN THESE RATS AT ANY OF THE INJECTION SITES. [IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work)., p. V16 167 (1978)]**PEER REVIEWED**
  • ...20 MALE & 20 FEMALE 10-WK-OLD WISTAR RATS RECEIVED WEEKLY INJECTIONS OF 0.4 ML OF 4% ...(FOOD GRADE) IN 0.9% SALINE INTO POSTERIOR THIGH MUSCLES OF THE RIGHT LEG. ...5/19 MALES & 9/18 FEMALES DEVELOPED RHABDOMYOSARCOMAS @ INJECTION SITE. ... METASTASES OCCURRED IN LYMPH NODES, LUNGS & LIVER. /NONE/ IN CONTROLS. [IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work)., p. V16 167 (1978)]**PEER REVIEWED**
  • SULFAN BLUE WAS FOUND TO BE THE MOST VALUABLE DYE TESTED FOR VISUALIZATION IN PRIMARY IRRITATION STUDIES USING GUINEA PIGS, MICE AND RABBITS. NO ADVERSE EFFECTS WERE OBSERVED AFTER 10 TIMES THE CLINICAL DOSE OR DAILY TREATMENT WITH THE RECOMMENDED DOSE FOR 5 DAYS. [BROWN VK, CLARKE RA; J INVEST DERMATOL 45 (3): 173 (1965)]**PEER REVIEWED**
  • IN ACUTE TOXICITY STUDIES, MICE AND RATS TOLERATED SINGLE ORAL DOSES OF 5 & 10 G/KG, RESPECTIVELY OF BLUE VRS SODIUM WITHOUT ANY ILL EFFECTS. IN RATS GIVEN DIETARY LEVELS OF 0.3, 0.75, 1.5, OR 3.0 BLUE VRS FOR 90 DAYS, GROWTH WAS RETARDED IN MALES AT THE 1.5 & 3.0 LEVELS AND FEMALES AT THE 3 LEVEL SHOWED AN INCR IN THE INCIDENCE OF FATTY LIVER. [HALL DE ET AL; FOOD COSMET TOXICOL 5 (2): 165 (1967)]**PEER REVIEWED**
  • TWICE WEEKLY SC INJECTIONS OF THE FOOD COLORING SURFACTANT, BLUE VRS TO RATS ELICITED A DERANGED CONNECTIVE TISSUE REPAIR WITH CONTINUED PROLIFERATION OF FIBROBLASTS & EXTENSIVE COLLAGEN DEPOSITION. SUCH SURFACTANTS GAVE RISE TO LOCAL SARCOMATA ONLY AFTER APPROXIMATELY 47 WEEKS. [HOOSON J ET AL; BRIT J CANCER 27 (3): 230 (1973)]**PEER REVIEWED**
  • NO MUTAGENICITY WAS DETECTED WITH THE SINGLE SAMPLE OF PATENT BLUE V TESTED WITH SALMONELLA TYPHIMURIUM. [BONIN AM ET AL; MUTAT RES 89: 21 (1981)]**PEER REVIEWED**
  • PATENT BLUE V HAS PROVEN NON-MUTAGENIC AND INCAPABLE OF INDUCING NON-SPECIFIC DNA DAMAGE WITH OR WITHOUT MICROSOMES IN SEVERAL SYSTEMS. [COMBES RD, HAVELAND-SMITH RB; MUTAT RES 98 (2): 101 (1982)]**PEER REVIEWED**
  • Sulfan blue was found to be positive when tested for mutagenicity using the Salmonella/microsome preincubation assay, using the standard protocol approved by the National Toxicology Program (NTP). Sulfan blue was tested in as many as 5 Salmonella typhimurium strains (TA1535, TA1537, TA97, TA98, and TA100) in the presence and absence of rat and hamster liver S-9, at doses of 0.100, 0.333, 1.000, 3.333, and 10.000 mg/plate. The compound was positive in strain TA98 with activation. The lowest positive dose tested was 0.333 mg/plate in strain TA98 with 10% hamster liver S-9. [Mortelmans K et al; Environ Mutagen 8:1-119 (1986)]**PEER REVIEWED**
  • Three widely used dyes, acridine orange, blue VRS and fast green FCF were admin to male mice ... to /examine/ the induction of gross chromosomal anomalies using the micronucleus test. All three cmpd were shown to be clastogenic. [Misra RN, Misra B; Mutat Res 170 (1-2): 75-8 (1986)]**PEER REVIEWED**
  • Liposomes produced from phosphatidylcholine and cholesterol and containing Parent Blue V has been injected endolymphatically in the rabbit. The lymph nodes stained dark blue and retained this color until termination of the /study/ after 28 days. No toxic effects were observed histologically. The liposomes were deposited within the macrophages in a fine granular pattern. ... [Hirnle P; J Pharm Pharmacol 43 (4): 217-8 (1991)]**PEER REVIEWED**
  • Patent blue 4 was of low acute oral toxicity in rats and mice. Although a 13 wk feeding study in dogs suggested a mild effect on the kidneys and gall bladder, a lifetime feeding study in mice using higher doses found only reduced growth and slight effects on the blood. Patent Blue V had no adverse effects on the reproduction of rats or mice treated orally. There was ... no evidence of carcinogenicity in mice given repeated oral doses. No genotoxic activity was demonstrated in a range of screening assays including a test for chromosomal damage in mice and Ames tests for mutagenicity in bacteria. ... [BIBRA Working Group; Patent Blue V. Toxicity Profile. BIBRA Toxicology Intl 4pp (1991)]**PEER REVIEWED**

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Human Toxicity Values

  • None found

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Non-Human Toxicity Values

  • None found

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Absorption, Distribution and Excretion

  • None found

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Metabolism/Metabolites

  • None found

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TSCA Test Submissions

  • None found

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Footnotes

1 Source: the National Library of Medicine's Hazardous Substance Database, 10/28/2007.

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Web page last updated on May 14, 2008