Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-05-23 to 2006-05-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study reliable without restrictions Minor deviations without an effect on the study: - According to the guideline a rationale for in vivo testing should be stated in the study report. This is missing in this study report. - According to the guideline, the individual body weight at start and conclusion of the the test should be stated. The body weight at the conclusion of the test is missing. - In the Draize scoring system referes conjunctival redness to palpebral and bulbar conjunctivae and excludes cornea and iris. In this study cornea and iris are included in the scoring system.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
, adopted 2002-04-24
Deviations:
yes
Remarks:
Minor deviations with no effect on the study (see rationale for reliability)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Peconal H
- Physical state: Pink powder
- Storage condition of test material: At room temperature and under argon gas
- The pH of the test item was not measurable (test item not soluble in water)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: On the day of treatment, the animal was 2 to 4 months old
- Weight at study initiation: 2.7 kg
- Housing: The animal was housed in Pajon cage (50 cm X 57 cm X 75 cm) equipped with a food container and a water bottle.
- Diet: During the study, the animal had free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (ad libitum): Drinking water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Relative humidity: 30 to 70 %
- Ventilation: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item in its original form
No further information on amount/concentration applied was stated.
Duration of treatment / exposure:
not stated
Observation period (in vivo):
The eyes were examined approximately 1 hour and 24 hours after administration of the test item. As severe irritant effects were observed, the animal was scarificed on day 2 (after scoring) for ethical reasons.
Number of animals or in vitro replicates:
1 male rabbit
Details on study design:
REMOVAL OF TEST SUBSTANCE
The eyes were not rinsed after administration of the test item.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Conjucntival reactions, iritis and corneal opacification were evaluated daily for each animal. For evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution ( a clear fluorscence is visible in the area of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary.
No further information in details on study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Max. score:
3
Remarks on result:
other: Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons on day 2 (after scoring).
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 hours
Score:
3
Max. score:
3
Remarks on result:
other: Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons at 24 hours (after scoring).
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Remarks on result:
other: Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons at 24 hours (after scoring).
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 hours
Score:
4
Max. score:
4
Remarks on result:
other: Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons at 24 hours (after scoring).
Irritant / corrosive response data:
A severe chemosis (maximal grade of 4), a severe redness of the conjunctiva (maximal grade of 3) and a clear discharge were observed on days 1 and 2.
The evaluation of iris and corneal lesions was masked by severe chemosis.
A brownish area on the conjunctivae, similar to a burn, was noted on day 2.
Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons at 24 hours (after scoring).

Any other information on results incl. tables

Raw data of one animal examined at 1 hour and 24 hours.

Rabbit No.

Region of eye

Eye irritation

1 hour

Day 1

24 hours

Day 2

1

Conjunctivae

Chemosis

4

4

Redness

3

3

Discharge

2

3

Iris

 

Scoring masked by marked chemosis

Scoring masked by marked chemosis

Corneal opacity

Intensity

Scoring masked by marked chemosis

Scoring masked by marked chemosis

Area

Scoring masked by marked chemosis

Scoring masked by marked chemosis

 

Other

 

Residual test item

Brownish area on conjunctiva

 

Fluorescein

 

Fluorescein not used

Fluorescein not used

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the test item Peconal H was severly irritant when administered by ocular route to rabbits.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, the test item Peconal H should be classified as irritating to the eyes abd assigned the symbol Xi, the indication of danger "Irritant" and the risk phrase R 41: "Risk of serious damage to eyes".
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 1.