Troclosene sodium

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

Monosodium cyanurate monohydrate

IUPAC Name:

Monosodium cyanurate monohydrate

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

Controls

Controls 1

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 )

Controls 2

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)

Controls 3

Negative solvent / vehicle controls:

yes

Remarks:

Water

Positive controls:

yes

Positive control substance:

other: NaNO2 9 mg/plate (TA1535 without S9 mix)

Controls 4

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)

Controls 5

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.