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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 March 1980 - 28 March 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study but not conducted to GLP or current guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Proposed guidelines for registering pesticides in the U.S.; Hazard Evaluation: Humans and domestic animals, Section 163.84-1 (43 FR 37388)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Monosodium cyanurate monohydrate
- Physical state: Solid granules
- Analytical purity: 99.36% (equivalent to 77.34% cyanuric acid)

Method

Species / strain
Species / strain / cell type:
other: Toxicity testing: S. typhimurium: TA100|Spot test: S. typhimurium: TA1535, TA1537, TA97, TA98 and TA100|Plate incorporation test: S. typhimurium: TA1535, TA1537, TA97, TA98 and TA100
Metabolic activation:
with and without
Metabolic activation system:
S9 preparations from liver of Aroclor 1254-induced male Sprague-Dawley rats and Aroclor 1254-induced male CD-1 mice.
Test concentrations with justification for top dose:
Toxicity testing: 10 mg, 3mg, 1 mg, 0.2 mg, 0.04 mg and 0.01 mg of sample per plate for stock no. 2 and 10 mg per plate for stock no. 1.
Spot test: 25 mg per spot
Plate incorporation test: 10 mg, 3 mg, 1 mg, 0.2 mg, 0.04 mg and 0.01 mg of sample/plate
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
Water
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
Migrated to IUCLID6: 2µg/plate (TA 98 and TA100 without S9 mix )
Negative solvent / vehicle controls:
yes
Remarks:
Water
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
Migrated to IUCLID6: 5 µg/plate (TA 98 and TA100 with S9 mix)
Negative solvent / vehicle controls:
yes
Remarks:
Water
Positive controls:
yes
Positive control substance:
other: NaNO2 9 mg/plate (TA1535 without S9 mix)
Negative solvent / vehicle controls:
yes
Remarks:
Water
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene 20 µg/plate (TA1535 and TA1537 with S9 mix)
Negative solvent / vehicle controls:
yes
Remarks:
Water
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Migrated to IUCLID6: 20 µg/plate (TA 1537 without S9 mix)
Details on test system and experimental conditions:
METHOD OF APPLICATION: In agar (plate incorporation)







Results and discussion

Test results
Species / strain:
other: Toxicity testing: S. typhimurium: TA100 Spot test: S. typhimurium: TA1535, TA1537, TA97, TA98 and TA100|Plate incorporation test: S. typhimurium: TA1535, TA1537, TA97, TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
With metabolic activation: no cytotoxicity at concentrations ≤ 10 mg of sample per plate.Without metabolic activation: no cytotoxicity at concentrations ≤ 10 mg of sample per plate.

Any other information on results incl. tables

Table 1: Table for gene mutation assay with S9 activation

Concentration (mg/plate)

Revertant Colonies / Plate (mean from 3 separate tests)

TA98

TA100

TA1535

TA1537

10

31.7

231

14.3

7.7

3

47.7

260.3

17.3

5.3

1

31.3

266.7

19.3

8.7

0.2

34.7

257.3

14

9.7

0.04

28

254

15.7

10.7

0.01

40

262.3

21.7

10.3

Positive Control

1003

1863

509

270

Negative Control

35.7

255.7

18.7

12.3

Table 2: Table for gene mutation assay without S9 activation

Concentration (mg/plate)

Revertant Colonies / Plate (mean from 3 separate tests)

TA98

TA100

TA1535

TA1537

10

-

294.7

23.7

10.3

3

-

276.3

24

10.3

1

-

279

21.7

8.7

0.2

-

300.3

23.3

8

0.04

-

279.3

19.7

6.7

0.01

-

296.6

19

7.3

Positive Control

-

534

503

721

Negative Control

-

247.3

24.3

8

- not tested

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Cyanuric acid was not mutagenic towards Salmonella typhimurium test strains in plate incorporation or spot tests conducted with or without a rat microsomal activation system. No microbial toxicity was observed with or without microsomal activation.