2,5,7,10,11,14-hexaoxa-1,6-distibabicyclo[4.4.4]tetradecane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reference do not give sufficient experimental details: longer exposure time than recommended by OECD 404, 2002; no details on test material, test animals and little information on administration

Justification for type of information:

REPORTING FORMAT FOR THE CATEGORY APPROACH

1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
The read-across hypothesis is that different Sb 3+ substances, such as ATEG and Antimony Trioxide (ATO) will give rise to/release (the same) common compound to which an organism will be exposed. On this basis the substances can be grouped as each are releasing a valence-specific (3+) soluble metal (oxyan)ion. The release of the specific Sb 3+ ion can be considered a common transformation product no matter how the transformation occurs.

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL

Upon dissolution in aqueous media at physiologically relevant concentrations and pH conditions, the only aqueous antimony species emerging from all considered trivalent antimony substances is the trivalent antimony cation. In vitro bioaccessibility testing in various artificial body fluids (Hedberg et al., 2010) has shown that ATEG compared to diantimony trioxide has a similar release rate of antimony ions.
Thus, with respect to this endpoint, read-across from ATO and other Sb 3+ compounds toward ATEG is justified

Cross-reference

Reason / purpose for cross-reference:

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:

The day before administration the eight albino rabbits were clipped over the entire trunk, care being taken to avoid cutting or abrading the skin. A single dose of 25g antimony trioxide dust incorporated in aqueous methylcellulose paste was applied to the denuded skin. The test site areas were about two-thirds of the animals`torso. They were covered by an impervious membrane (Vinylite). The test item was applied for one week. After exposure local skin reactions and signs of systemic toxicity were examined.

GLP compliance:

not specified

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

Test animals

Species:

other: albino rabbits

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped over the entire trunk without cutting the skin

Vehicle:

other: aqueous methylcellulose paste

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 g of antimony trioxide dust incorporated in aqueous methylcellulose paste
- Concentration (if solution): not stated


VEHICLE
- Amount(s) applied (volume or weight with unit): not stated
- Concentration (if solution): not stated
- Lot/batch no. (if required): not stated
- Purity:not stated

Duration of treatment / exposure:

one week

Observation period:

not stated

Number of animals:

eight albino rabbits

Details on study design:

TEST SITE
- Area of exposure: The Methylcellulose paste was applied to the intact skin of two-thirds of the animals' torso.
- Type of wrap if used: The area was covered by an impervious membrane (Vinylite).

Results and discussion

In vivo

Results

Basis:

other: All Animals

Time point:

7 d

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No significant local reaction.

Other effects:

No apparent sign of systemic toxicity.

Any other information on results incl. tables

No significant local reaction. No apparent sign of systemic toxicity.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

No significant local reaction.