Registration Dossier
Registration Dossier
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EC number: 249-820-2 | CAS number: 29736-75-2
Eye irritation
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:
- 2 005
- 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
- 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
Constituent 1
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
Table 2 Acute eye irritation/corrosion test of Antimony trioxide in rabbits / untreated left eye
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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.
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