Antimony pentachloride

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was generated according to valid testing guideline: OECD guideline 471

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Diantimony trioxide

EC Number:

215-175-0

EC Name:

Diantimony trioxide

Cas Number:

1309-64-4

Molecular formula:

Sb2O3

IUPAC Name:

dioxodistiboxane

Test material form:

not specified

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Species / strain 3

Species / strain / cell type:

E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

The doses tested were 100, 200, 500, 1000, 2500 and 5000 µg/plate.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

further positive control substances: ICR, daunorubicin, ethylnitrosoguanidine, 2-aminoanthracene, mitomycin c

Details on test system and experimental conditions:

METHOD OF APPLICATION:
- in agar (plate incorporation) and preincubation

- For the plate incorporation protocol, 0.5 ml of S9-mix (or buffer), 0.1 ml of bacteria culture, 0.1 ml of test compound and 2.0 ml top agar were mixed and poured onto agar plates. These were incubated at 37°C for 3 days before counting on an automatic colony counter.
- The preincubation protocol (conducted for the presence of S9-mix) included 60 minutes incubation at 37°C on an orbital shaker before the addition of top agar.


DURATION
- Preincubation period: 60 minutes

OTHER:
- The S9-mix was prepared from male Sprague-Dawley rates dosed daily by oral gavage for 3 days with a combined phenobarbital (80 mg/kg bw) and ß-naphthoflavone (100 mg/kg) corn oil solution. The cofactor was a solution of Na2HPO4, KCl, glucose-6-phosphate, NADP (Na salt) and MGCl2, pH 7.4.

- no other details on test system stated

Evaluation criteria:

Increase of the numers of bacteria colonies.

Statistics:

No statistics were performed to evaluate the result.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES:
- Antimony trioxide induced no increases in revertant numbers in four S. typhimurium and two E. coli tester strains in two independent assays, including both plate incorporation and preincubation protocols in the presence of S9-mix, at doses up to 5000 µg/plate.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Assessment of antimony trioxide in the Salmonella/microsome assay

Strain	Concentration (µg/plate)	Mean revertants per plate
.	.	- S9-mix Phase1	+ S9-mix Phase 1	- S9-mix Phase2	+ S9-mix Phase 2 (preincubation)
TA 1535	5000	11.7	11.0	6.7	14.7
	2500	14.3	14.3	6.3	15.0
	1000	10.3	16.7	7.7	12.3
	500	12.3	16.0	9.0	13.0
	200	10.0	15.7	11.0	13.0
	100	14.0	17.7	6.7	12.7
	0	10.8 (1194)^a	15.0 (203)^e	9.0 (793)^a	14.4 (106)^f
TA 1537	5000	4.0	5.3	4.3	1.7
	2500	5.3	4.3	2.7	3.0
	1000	4.3	4.7	2.7	3.3
	500	3.7	4.7	3.0	3.3
	200	3.7	4.0	3.7	5.0
	100	3.7	3.7	3.3	3.7
	0	3.0 (64)^b	3.6 (82)^e	3.4 (45)^b	4.0 (29)^f
TA 98	5000	19.3	12.3	17.3	16.0
	2500	19.7	21.0	17.3	22.0
	1000	23.7	26.7	18.0	19.7
	500	20.3	21.7	16.7	23.0
	200	22.3	21.7	19.3	23.0
	100	19.3	19.7	17.3	23.0
	0	20.8 (108)^c	23.6 (673)^f	17.4 (395)^c	21.2 (288)^f
TA 100	5000	85.7	108.7	97.7	139.0
	2500	82.0	124.0	109.7	123.0
	1000	92.0	132.3	95.3	127.0
	500	81.3	120.7	115.3	127.7
	200	83.0	124.7	109.3	135.0
	100	78.0	118.7	125.3	132.7
	0	82.4 (788)^a	92.6 (802)^f	117.2 (1681)^a	119.8 (899)^f
WP2P	5000	34.3	51.7	23.3	56.3
	2500	35.0	42.7	23.7	52.3
	1000	34.0	52.3	22.3	49.3
	500	38.7	45.7	24.7	52.7
	200	40.7	50.7	22.3	50.3
	100	34.7	40.3	29.3	56.3
	0	35.6 (210)^h	47.6 (176)^g	30.6 (159)^h	50.4 (182)^g
WP2PuvrA	5000	110.7	163.7	89.7	156.7
	2500	112.0	165.0	89.7	149.0
	1000	117.0	150.3	99.0	157.0
	500	105.7	157.3	93.0	132.0
	200	130.3	168.3	89.0	144.7
	100	106.0	515.7	96.3	147.3
	0	97.8 (1681)^d	139.8 (1009)^e	89.6 (2962)^d	128.6 (1335)^e

All mean revertants per plate values are the mean of three plates, except solvent controls (0µg/ml) which are the mean of five plates.

Positive controls (µg/plate).

^a Sodium azide (2.0); ^b ICR 191 (2.0); ^cDaunorubicin (1.0);  ^d Ethylnitronitrosoguanidine (1.0); ^e2-Aminoanthracene (2.0); ^f 2-Aminoanthracene (1.0); ^g2-Aminoanthracene (20); ^h Mitomycin C (1.0)

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Diantimony trioxide did not induce reverse mutations in bacteria in this study under the conditions described.