Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test conducted according to internationally accepted testing procedures and according to the GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli snc, via Milano 61, 28041 Arona (NO), Italy.
- Age at study initiation: 8 - 9 weeks old.
- Weight at study initiation: 2 - 2.3 kg
- Diet: ad libitum.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2 °C
- Humidity: 55 %
- Air changes: 15-20 per hr.
- Photoperiod: 12 hrs dark / 12 hrs light.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

TOOL USED TO ASSESS SCORE: fluorescein

OBSERVATION
Inspections for mortality and general clinical signs were made once a day.

SCORING SYSTEM
The eye irritation was assessed at 1, 24, 48, 72 hours and 4 and 7 days after treatment.
CORNEA:
Opacity and degree of density (area most dense taken for reading) .
No opacity: 0
Scattered or diffuse area, details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
Opaque, iris invisible: 4

IRIS:
A Values
Normal: 0
Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive: 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2

CONJUNCTIVAE:
A Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal: 0
Vessels definitely injected above normal: 1
More diffuse, deeper crimson red, individual vessels not easily discernible: 2
Diffuse beefy red: 3

B Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to completely closed: 4

Results and discussion

In vivo

Irritant / corrosive response data:
Locally at the application site, notable changes mainly consisting of conjunctival redness and chemosis were noted up to 72 hours after treatment. However, no residual ocular changes were detected at the last observation time, 7 days after exposure
Other effects:
Neither mortality nor adverse general clinical modifications were seen during the study.

Any other information on results incl. tables

Moderate (grade 2) conjunctival redness and slight to moderate (grade 2 or 3) chemosis were noted in all rabbits at the readings carried out 1 hour after application. At the subsequent observations, 24 and 48 hours after treatment, conjunctuval redness became severe (grade 3), while chemosis decreased to very slight (grade 1).

Moreover, a focal moderate hemorragic area was detected in one animal at each of the 24-and 48-hour readings. Conjunctival changes decreaaed in severity and/or frequency 72 hours after application and disappeared by the last observation time, 7 days after exposure.

Negative results were obtained at the fluorescein staining performed 24 hours after application.

Effect Animal N. Score mean at 24, 48 and 72 hours
cornea #1 0.00
cornea #2 0.00
cornea #3 0.00
iritis #1 0.00
iritis #2 0.00
iritis #3 0.00
conjunctival redness #1 3.00
conjunctival redness #2 2.67
conjunctival redness #3 3.00
chemosis #1 1.00
chemosis #2 0.67
chemosis #3 3.00

Applicant's summary and conclusion

Interpretation of results:
other: Eye irrit. 2 (H319), according to the CLP Regulation
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Eye irrit. 2 (H319)
Executive summary:

The test was performed on 3 New Zealand White rabbits. The test material was placed in an amount of 0.1 g into the right eye of the rabbits. The eye irritation assessment was made at 1, 24, 48 and 72 hours.

Moderate conjunctival redness and slight to moderate chemosis were noted in all rabbits at the readings carried out 1 hour after application. At the subsequent observations, 24 and 48 hours after treatment, conjunctuval redness became severe, while chemosis decreased to very slight.

Moreover, a focal moderate haemorragic area was detected in one animal at each of the 24-and 48-hour readings. Conjunctival changes decreased in severity and/or frequency 72 hours after application and disappeared by the last observation time, 7 days after exposure.

No residual ocular changes were detected at the last observation time, 7 days after exposure

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, in all the tested rabbits; lower than 1 for irtitis, in all the tested rabbits; lower than 2 for oedema in two of three tested animals and higher than 2 for conjunctival in all the tested animals. All reactions recorded were fully reverses within an observation period of 7 days.

Thus, the test item is classified as irritating to eye, category 2 (H319) according to the the CLP (EC 1272/2008) Regulation.