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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation of the study is insufficient for assessment. The extract was not analysed and the amount of antimony trioxide not known, the number of animals included in the study was not stated and no control animals was used.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1950

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline specified at the time of conduct.
In this briefly reported study the toxicity of a polythene composition containing antimony trioxide (polythene + 0.2% “Akroflex” C/ antimony trioxide
/“Chlorowax”) was tested.
(1) 10 g of the composition were mixed with 20 ml of 5% citric acid and let stand 48 hours at room temperature.
The solids were then removed by filtration and the filtrate neutralised to pH 6 with sodium bicarbonate. Single doses of the neutralised extract,
varying from 1 to 4 ml, were fed to rats without producing any toxic effects.
(2) 1500 mg/kg/day were fed to 6 rats for 5d/wk for a total of 10 treatments.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Polythene composition JRP-10083-B (polythene + 0.2%"Akroflex" C / antimony trioxide /
"Chlorowax" 70 57/20/15)
- Substance type: formulation
- Composition of test material, percentage of components: polythene + 0.2% “Akroflex” C/ antimony trioxide/ “Chlorowax”
- no other details on test material stated

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: (1) 10 g of the composition were mixed with 20 ml of 5% citric acid and let stand 48 hours at room temperature. The solids were then removed by filtration and the filtrate neutralised to pH 6 with sodium bicarbonate. (2) no vehicle
Details on oral exposure:
VEHICLE
(1) - 10 g of the composition were mixed with 20 ml of 5% citric acid and let stand 48 hours at room temperature.
- The solids were then removed by filtration and the filtrate neutralised to pH 6 with sodium bicarbonate.
(2) - no vehicle


MAXIMUM DOSE VOLUME APPLIED: (1) varying from 1 to 4 ml

- no other details on oral exposure are stated
Doses:
(1) not analysed in final extract
(2) 1500 mg/kg/day for 5 days/wk and total of 10 treatments
No. of animals per sex per dose:
(1) not stated
(2) 6 rats
Control animals:
no

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
other: fatal dose
Effect level:
> 7 500 mg/kg bw
Remarks on result:
other: experiment (2)
Mortality:
(1) no mortality
(2) no mortality
Clinical signs:
(1) no toxic effects
Body weight:
(2) growth rate retarded during feeding period
Gross pathology:
(2) gross and micropathological examination did not show any organic damage attributable to the substrate

Any other information on results incl. tables

(1) The extract was not analysed and the amount of antimony trioxide not known, the number of animals included in the study was not stated and no control animals was used.

Applicant's summary and conclusion

Conclusions:
This study is regarded as invalid and will not be used for the risk assessment of diantimony trioxide, due to the fact that the extract was not analysed and the amount of diantimony trioxide not known, the number of animals included in the study was not stated and no control animals was used.