Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
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:
2005
Report Date:
2005

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
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

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.