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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Begin: 2005-07-18, End: 2005-08-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented guideline study.
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

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 / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: female Himalayan rabbit
- Age at study initiation: approx. 4-5 month
- Weight at study initiation:
animal # 1: 2.8 kg
animal # 2: 2.2 kg
animal # 3: 2.2 kg
- Housing:For 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine.
- Diet (e.g. ad libitum): ssniff K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. The food was available ad libitum.
- Water (e.g. ad libitum): Tab water was offered daily ad libitum
- Acclimation period: at least 20 adaptation days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): Rooms were lit and darkened on a 12-hour light/12-hour dark cycle.


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye which remained untreated, served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg antimony trioxide powder
- Purity: 99.93%
- no other details on amount/concentration applied are given
Duration of treatment / exposure:
according to guideline
Observation period (in vivo):
1, 24, 48, 72 hours and 4 days after administration
Number of animals or in vitro replicates:
three Himalayan rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
1
Irritation parameter:
cornea opacity score
Remarks:
lesions
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: the test did not reveal any corneal lesions
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: the iris was not affected by instillation of the item
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Other effects:
There were no systemic intolerance reactions.

Any other information on results incl. tables

Table 1. Acute eye irritation/corrosion test of Antimony trioxide in rabbits / right eye

Time after administration

CORNEA

Opacity

IRIS

CONJUNCTIVAE

Redness         Chemosis

Before dosing

0/0/0

0/0/0

0/0/0

0/0/0

1h

0/0/0

0/0/0

0/0/0

0/0/0

24hrs

0/0/0

0/0/0

0/1/1

0/0/0

48hrs

0/0/0

0/0/0

0/0/1

0/0/0

72hrs

0/0/0

0/0/0

0/0/1

0/0/0

4 days

-/-/0

-/-/0

-/-/0

-/-/0

right eye: 100 mg Antiomony trioxide

24 hrs fluorescein test: all animals: no corneal lesions

Animal No.: 1/2/3

Table 2 Acute eye irritation/corrosion test of Antimony trioxide in rabbits / untreated left eye

Time after administration

CORNEA

Opacity

IRIS

CONJUNCTIVAE

Redness        Chemosis

Before dosing

0/0/0

0/0/0

0/0/0

0/0/0

1h

0/0/0

0/0/0

0/0/0

0/0/0

24hrs

0/0/0

0/0/0

0/0/0

0/0/0

48hrs

0/0/0

0/0/0

0/0/0

0/0/0

72hrs

0/0/0

0/0/0

0/0/0

0/0/0

4 days

-/-/0

-/-/0

-/-/0

-/-/0

left eye: untreated

24 hrs fluorescein test: all animals: no corneal lesions

Animal No.: 1/2/3

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Mild conjunctival redness was observed in 2 animals 24h post exposure. However, the effect does not fullfill the EU-criteria for classification as irritant.