Sodium 2-naphthol-3,6-disulfonate was studied for oral toxicity in Crj:CD(SD) rats in a 28-day repeat dose toxicity test at doses of 0, 100, 300 and 1000 mg/kg.
No deaths occurred of either males and females. Mydriasis was observed in males and females of the 1000 mg/kg group. No effects related to the test article were observed for body weights, and food consumption and on urinalysis and hematological, blood chemical and pathological examinations. In the recovery test, changes observed during the administration period disappeared. The NOEL is considered to be 300 mg/kg/day for both sexes under the conditions of the present study.
Sodium 2-naphthol-3,6-disulfonate was not mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA.
Sodium 2-naphthol-3,6-disulfonate did not induce structural chromosomal aberrations and/or polyploidy in CHL cells with and without an exogenous metabolic activation system.
| Purity | : | 96.4 % |
| Test species/strain | : | Rat/Crj:CD(SD) |
| Test method | : | Guidelines for 28-day Repeat Dose Toxicity Testing of Chemicals(Japan) |
| Route | : | Oral(gavage) |
| Dosage | : | 0(Vehicle), 100, 300, 1000 mg/kg/day |
| Number of animals | : | Males, 6 or 12(0, 1000 mg/kg) Females, 6 or 12(0, 1000 mg/kg) |
| Vehicle | : | Water for injection |
| Administration period | : | Males and females, 28 days |
| Terminal kill | : | Males and females, days 29 or 43(0, 1000 mg/kg) |
| GLP | : | Yes |
Test results:
The NOEL was considered to be 300 mg/kg/day for both sexes under the conditions of the present study.
| Purity | : | 96.4 % |
| Test species/strain | : | Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA |
| Test method | : | Guidelines for Screening Mutagenicity Testing of Chemicals(Japan) |
| Procedures | : | Pre-incubation method |
| Solvent | : | Distilled water |
| Positive controls | : | -S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide(TA100, TA98, WP2 uvrA), Sodium azide(TA1535) and 9-Aminoacridine(TA1537) +S9 mix; 2-Aminoanthracene(all strains) |
| Doses | : | -S9 mix; 0, 156, 313, 625, 1250, 2500, 5000 μg/plate +S9 mix; 0, 156, 313, 625, 1250, 2500, 5000 μg/plate |
| S9 | : | Rat liver, induced with phenobarbital and 5,6-benzoflavone |
| Plates/test | : | 3 |
| Number of replicates | : | 2 |
| GLP | : | Yes |
Test results:
Genotoxic effects:
S. typhimurium TA100, TA1535, TA98, TA1537
| + | ? | - | |
| Without metabolic activation: | [ ] | [ ] | [*] |
| With metabolic activation: | [ ] | [ ] | [*] |
E. coli WP2 uvrA
| + | ? | - | |
| Without metabolic activation: | [ ] | [ ] | [*] |
| With metabolic activation: | [ ] | [ ] | [*] |
| Purity | : | 96.4 % |
| Type of cell used | : | Chinese hamster lung(CHL)cells |
| Test method | : | Guidelines for Screening Mutagenicity Testing of Chemicals(Japan) |
| Solvent | : | JP saline |
| Positive controls | : | -S9 mix, N-Methyl-N'-nitro-N-nitrosoguanidine +S9 mix, Benzo[a]pyrene |
| Doses | : | -S9 mix(24 and 48-hr continuous treatment): 0, 1250, 2500, 5000 μg/mL -S9 mix(6-hr short-term treatment): 0, 1250, 2500, 5000 μg/mL +S9 mix(6-hr short-term treatment): 0, 1250, 2500, 5000 μg/mL |
| S9 | : | Rat liver, induced with phenobarbital and 5,6-benzoflavone |
| Plates/test | : | 2 |
| GLP | : | Yes |
Test results:
Genotoxic effects:
| clastogenicity | polyploidy | |||||
| + | ? | - | + | ? | - | |
| Without metabolic activation: | [ ] | [ ] | [*] | [ ] | [ ] | [*] |
| With metabolic activation: | [ ] | [ ] | [*] | [ ] | [ ] | [*] |
| 1) | The tests were performed by the Safety Assessment Laboratory, Panapharm Laboratories Co., Ltd. 1285 Kurisaki-machi, Uto-shi, Kumamoto, 869-0425, Japan Tel +81-964-23-5111 Fax +81-964-23-2282 |
| 2) | The tests were performed by the Research Institute for Animal Science in Biochemistry and Toxicology, 3-7-11 Hashimotodai, Sagamihara-shi, Kanagawa 229-1132, Japan. Tel +81-42-762-2775 Fax +81-42-762-7979 |