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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study is comparable to guideline study with acceptable restrictions: Higher dose of administration (approx. 8300 mg) than recommended by OECD 402 (limit dose: 2000 mg) not expected to have an major impact on test result. Lack of details of test animals (eg. sex and weights) and environmental conditions; for a limit test 5 male and 5 females are recommended in the guideline.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1955

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline specified at the time of conduct.
8 albino rabbits (strain and sex not stated) were administered 25 g antimony trioxide. The geometric mean was 1.3 µ ± 1.65µ and the antimony trioxide was contaminated with 0.2% arsenic.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
- no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: aqueous methylcellulose paste
Details on dermal exposure:
∙ method of application was adapted from the procedure of Draize and associates with minor modifications
∙ the day before dosing the animals were clipped over the entire trunk with an electric clipper, care being taken to avoid cutting or abrading the skin.
∙ applied to the denuded skin, which comprised about two third of the animals torso

TEST SITE
- Area of exposure: torso (applied to the denuded skin)
- coverage: 2/3 of the animals torso
- Type of wrap if used: impervious membrane (Vinylite) for one week

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 g of antimony trioxide dust
- For solids, paste formed: yes

- no other details on exposure are stated
Duration of exposure:
the impervious membrane (Vinylite) remained in contact for one week (ca. 168 h)
Doses:
25 g of antimony trioxide on each animal
No. of animals per sex per dose:
8 animals
Control animals:
no
Details on study design:
- no data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 8 300 mg/kg bw
Remarks on result:
other: According to the TGD a body weight of 3.0 kg should be applied for the rabbits which gives a dose of 8.3 g/kg bw.
Mortality:
no deaths
Clinical signs:
∙ after this single application: no significant local reaction or any apparent sign of systemic toxicity was observed

Any other information on results incl. tables

No mortality or other clinical symptoms were reported in this study. Consequently, a LD50 > 8300 mg/kg bw can be derived for dermal exposure of rabbit. No significant local reaction or any apparent sign of systemic toxicity was observed after this single application.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality or other clinical symptoms were reported in this study. Consequently, a LD50 > 8300 mg/kg bw can be derived for dermal exposure of rabbit. No significant local reaction or any apparent sign of systemic toxicity was observed after this single application.