Registration Dossier
Registration Dossier
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EC number: 215-175-0 | CAS number: 1309-64-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- 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.
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:
- oxostibanyl stibinate
- 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:
- other: 24,48 and 72 hours
- Score:
- 0.44
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Remarks:
- lesions
- Basis:
- mean
- Time point:
- other: 24,48 and 72 hours
- 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:
- other: 24, 48 and 72 hours
- 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:
- other: 24,48 and 72 hours
- 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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