Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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 474
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 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
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

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: male and female CD-1 mice supplied by Charles River Breeding Laboratories (Margate, UK)
- Age at study initiation: 5-11 weeks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12-hours light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
0.5% w/vhydroxypropylmethylcellulose in 0.1% w/v aqueous polysorbate 80.
Duration of treatment / exposure:
single oral gavage dose
Frequency of treatment:
once
Post exposure period:
Sampling times were 24 and 48 hours post dosing.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
400 mg/kg
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
667 mg/kg
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
1000 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
5 male and 5 female
Control animals:
yes, concurrent vehicle
Positive control(s):
Cyclophosphamide was used as positive control.

Examinations

Tissues and cell types examined:
polychromatic erythrocytes
Details of tissue and slide preparation:
DETAILS OF SLIDE PREPARATION:
- Slides were scored blindly.

METHOD OF ANALYSIS:
Two thousand polychromatic erythrocytes were examined for micronuclei per animal.

Statistics:
The statistical analysis consisted of a one-sided Student´s t-test on transformed data.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
A significant decrease in the percent polychromatic erythrocytes was only seen in females at the 24 h sampling time in the single dose study.

Any other information on results incl. tables

Table 1: Assessment of antimony trioxide in the mouse bone marrow micronucleus assay: single dose, male

treatment

dose

males

.

.

mean incidence of MPE/1000 PE ± SD

mean % of polychromatic erythrocytes ± SD

.

.

24 hours

48 hours

24 hours

48 hours

Vehicle control

10 ml/kg

1.5 ± 0.6

0.2 ± 0.3

42.5 ± 8.9

37.6 ± 11.1

Cyclophosphamide

65 mg/kg

19.2 ± 5.2**

41.3 ± 5.2

Antimony trioxide

5000 mg/kg

0.8 ± 0.6

0.6 ± 0.7

41.9 ± 5.7

34.6 ± 13.9

PE: polychromatic erythrocytes; MPE: micronucleated polychromatic erythrocytes; SD: standard deviation.

All means of MPE/1000 PE based on ten observations (two counts of 1000 PE per animal).

All means of % PE based on five observations (one count of 1000 erythrocytes per animal).

** statistically significant increase or decrease over controls (p0.01 in Students t-test (one-sided) on transformed data).

Table 2: Assessment of antimony trioxide in the mouse bone marrow micronucleus assay: single dose, female

treatment

dose

females

.

.

mean incidence of MPE/1000 PE ± SD

mean % of polychromatic erythrocytes ± SD

.

..

24 hours

48 hours

24 hours

48 hours

Vehicle control

10 ml/kg

0.8 ± 0.5

0.6 ± 1.1

41.4 ± 8.8

44.2 ± 5.1

Cyclophosphamide

65 mg/kg

16.2 ± 2.8**

43.0 ± 6.6

Antimony trioxide

5000 mg/kg

1.4 ± 0.9

1.2 ± 0.9

26.7 ± 7.2**

39.9 ± 12.8

PE: polychromatic erythrocytes; MPE: micronucleated polychromatic erythrocytes; SD: standard deviation.

All means of MPE/1000 PE based on ten observations (two counts of 1000 PE per animal).

All means of % PE based on five observations (one count of 1000 erythrocytes per animal).

** statistically significant increase or decrease over controls (p0.01 in Students t-test (one-sided) on transformed data).

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
No statistically significant increase in the incidence of micronuclei was observed in the single or repeated dose study.