Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

AY23 - Testing of 24 Food, Drug, Cosmetic, and Fabric Dyes in the In Vitro and the In Vivo/ In Vitro Rat Hepatocyte Primary Culture/ DNA Repair Assays

Author:

Douglas Kornbrust and Thomas Barfknecht

Year:

1984

Bibliographic source:

Environmental Mutagenesis 7:lOl-120 (1985)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)

Deviations:

not specified

GLP compliance:

not specified

Type of assay:

other: HPC/DN repair assay

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

EC Number:

217-699-5

EC Name:

Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

Cas Number:

1934-21-0

Molecular formula:

C16H12N4O9S2.3Na

IUPAC Name:

trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate

Test material form:

solid: particulate/powder

Details on test material:

No data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Details on species / strain selection:

cesarean-derived

Sex:

male

Details on test animals or test system and environmental conditions:

Male Sprague Dawley cesarean-derived (Crl: COBS@ CD@ [SD] BR) rats (Charles River Breeding Laboratories, Inc., Kingston, NY), weighing 200-300 g, were used for all in vivo/in vitro HPC/DR assays, and also served as the source of hepatocytes for the in vitro HPC/DR assays. Prior to use, the animals were housed in humidity- and temperature-controlled rooms with 12-hr light/dark cycles, and allowed access to food and water ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Duration of treatment / exposure:

single application

Doses / concentrations

Dose / conc.:

500 mg/kg bw/day (nominal)

No. of animals per sex per dose:

not specified

Control animals:

other: Negative control: Acid Red 14 (Carmoisine)

Positive control(s):

Solvent Yellow 3 (0-aminoazotoluene)

Examinations

Evaluation criteria:

Consistent with the criteria employed by other investigators [Williams, 1977; Bermudez et al, 1979; Probst et al, 19811, average net nuclear grain counts of 5 or greater were assumed to constitute a positive response, since these differed from the control net nuclear counts by greater than 2 SD. On a historical basis in this laboratory, control incubations have invariably yielded an average value for net nuclear grains of less than zero. In the present study, NNG counts ranged from -0.6 to -2.8 and from -0.9 to -2.1 for no-solvent and 1% DMSO control incubations, respectively. In addition, the proportion of cells with 2 5 NNG was 6 8% for all control incubations [4.1 f 2.6% (mean -t standard deviation), n = 17). Therefore, net nuclear grain counts below zero were considered negative responses. For those dyes that produced responses between zero and 5 average net nuclear grains, it was generally not possible to demonstrate a statistically significant difference from the control value within a given experiment. Therefore, these responses were judged to be equivocal, unless, in addition to an average net nuclear grain count between zero and 5, at least 25% of the cells examined contained 2 5 net nuclear grains, in which case the response was considered weakly positive. Concentrations of the dyes that produced approximately 90% or greater detachment of the hepatocytes from the coverslips (as assessed visually by comparing to control slides) were assumed to be toxic and were not counted.

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

not specified

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Not mutagenic

Executive summary:

The tested substance showed negative results in the in vivo HPC/DR assay.