1-Naphthol-4-sulfonic acid sodium salt

1-ナフトール-4-スルホン酸ナトリウム


[CAS No. 6099-57-6]

Sodium 4-hydroxynaphalene-1-sulfonate

1-ナフトールスルホン酸ナトリウム

Molecular formula: C10H7NaO4S　Molecular weight: 160.17

ABSTRACT

A single dose oral toxicity test of 1-naphthol-4-sulfonic acid sodium salt revealed an LD50 value of above 2000 mg/kg for both sexes.

1-Naphthol-4-sulfonic acid sodium salt was studied in rats with a 28-day repeated dose oral toxicity test at doses of 0, 100, 300 and 1000 mg/kg. No deaths were observed in either sex. There were no changes attributable to the test substance in terms of general condition, body weights, and food consumption, or findings of urinalysis, hematological examination, blood chemical examination or pathological examination. The NOEL for the 28-day repeated dose oral toxicity test of 1-naphthol-4-sulfonic acid sodium salt is considered to be 1000 mg/kg/day for both sexes.

Genotoxicity of 1-naphthol-4-sulfonic acid sodium salt was studied by a reverse mutation test in bacteria and by a chromosomal aberration test in cultured Chinese hamster lung (CHL/IU) cells.

1-Naphthol-4-sulfonic acid sodium salt was not mutagenic in Salmonella typhimurium TA100, TA1535, TA98, TA1537 and Escherichia coli WP2 uvrA, with or without an exogenous metabolic activation system.

1-Naphthol-4-sulfonic acid sodium salt did not induce chromosomal aberrations in CHL/IU cells, with or without an exogenous metabolic activation system.

SUMMARIZED DATA FROM THE STUDIES

1. Single Dose Oral Toxicity 1)

Purity:95.7 %
Test species/strain:Rat/Crj:CD(SD)IGS
Test method:OECD Test Guideline 401
　Route:Oral (gavage)
　Dosage:0(vehicle), 2000 mg/kg
　Number of animals/group:Males, 5; females, 5
　Vehicle:Water for injection
GLP:Yes

　Test results:

There were no deaths. Loosening of stools was observed in 3 males and all females of the 2000 mg/kg group in the early period of observation. No effects were found on body weights or autopsy findings.

The LD50 value is concluded to be above 2000 mg/kg for both sexes.

2. Repeated Dose Oral Toxicity 1)

Purity:95.7 %
Test species/strain:Rat/Crj:CD(SD)IGS
Test method:Guideline for 28-Day Repeated Dose Toxicity Test in Mammalian Species (Chemical Substances Control Law of Japan)
　Route:Oral (gavage)
　Dosage:0 (vehicle), 100, 300, 1000 mg/kg
　Number of animals/groupMales, 10; females, 10 (0, 1000 mg/kg)
Males, 5; females, 5 (100, 300 mg/kg)
　Vehicle:Water for injection
　Administration period:Males and females, 28 days
　Terminal killing:Males and females, on days 29 and 43
GLP:Yes

　Test results:

In the repeated dose study, no deaths were observed in any group. There were no changes attributable to the test substance in terms of general conditions, body weights, and food consumption, or findings of urinalysis, hematological examination, blood chemical examination or pathological examination.

Thus, the NOEL for the 28-day repeated dose toxicity is considered to be 1000 mg/kg/day for both sexes.

3. Genetic Toxicity

3-1. Bacterial test 2)

Purity:95.7 %
Test species/strain:Salmonella typhimurium TA100, TA1535, TA98, TA1537, Escherichia coli WP2 uvrA
Test method:Guidelines for Screening Mutagenicity Testing of Chemicals(Chemical Substances Control Law of Japan) and OECD Test Guideline 471
　Procedures:Pre-incubation method
　Solvent:Distilled water
　Positive controls:-S9 mix; 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (TA100, TA98, WP2uvrA), Sodium azide (TA1535) and 9-Aminoacridine (TA1537)
+S9 mix; 2-Aminoanthracene (all strains)
　Dosage:-S9 mix; 0, 313, 625, 1250, 2500, 5000 μg/plate
+S9 mix; 0, 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:

This chemical did not induce gene mutations in the S. typhimurium and E. coli strains. Toxicity was not observed in any strain, with and without S9 mix.

Genetic effects:
Salmonella typhimurium TA100, TA1535, TA98, TA1537
+?-
Without metabolic activation:[ ][ ][*]
With metabolic activation:[ ][ ][*]

Escherichia coli WP2 uvrA
+?-
Without metabolic activation:[ ][ ][*]
With metabolic activation:[ ][ ][*]

3-2. Non-bacterial in vitro test (chromosomal aberration test) 2)

Purity:95.7 %
Type of cell used:Chinese hamster lung (CHL) cells
Test method:Guidelines for Screening Mutagenicity Testing of Chemicals (Chemical Substances Control Law of Japan) and OECD Test Guideline 473
　Solvent:Physiological saline
　Positive controls:-S9 mix; 1-Methyl-3-nitro-1-nitrosoguanidine
+S9 mix; 3,4-Benzo[a]pyrene
　Dosage:-S9 mix (6 hr short-term treatment); 0, 625, 1250, 2500 μg/mL
+S9 mix (6 hr short-term treatment); 0, 625, 1250, 2500 μg/mL
-S9 mix (24 hr continuous treatment); 0, 625, 1250, 2500 μg/mL
　S9:Rat liver, induced with phenobarbital and 5,6-benzoflavone
　Plates/test:2
GLP:Yes

　Test results:

With the 6 hr short-term treatment, chromosomal aberrations were not induced, with or without S9 mix. Moreover, chromosomal aberrations were not induced after the 24 hr continuous treatment without S9 mix.

Cytotoxicity was not observed in the 6 hr short-term treatment, with or without S9 mix and the 24 hr continuous treatment without S9 mix.

Genotoxic effects:
clastogenicitypolyploidy
+?-+?-
Without metabolic activation:[ ][ ][*][ ][ ][*]
With metabolic activation:[ ][ ][*][ ][ ][*]

1)The tests were performed by the Hatano Research Institute, Food and Drug Safety Center, 729-5 Ochiai, Hadano-shi, Kanagawa, 257-8523, Japan. Tel +81-463-82-4751 Fax +81-463-82-9627
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