Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 February and 12 March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study carried out in compliance with an internationally recognised guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

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)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: A reputable supplier
- Age at study initiation: 46 weeks
- Weight at study initiation: 3.84 kg
- Housing: plastic cage with perforated floors
- Diet: 125 g of a standard laboratory rabbit diet per day. Dietary supplement of hay was offered during acclimatisation until two days prior to dose instillation, for the remainder of acclimatisation and throughout the study observation period wholemeal bread was offered
- Water: ad libitum.
- Acclimation period: 26 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20°C
- Humidity (%): relative humidity within 40 to 70%.
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 light/12 hours dark

IN-LIFE DATES: From: To: 21 February to 12 March 2013

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL
Observation period (in vivo):
1, 24, 48, 72 hours and after 8 days
Number of animals or in vitro replicates:
1
Details on study design:
SCORING SYSTEM: as prescribed in the test guideline


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
2
Irritant / corrosive response data:
A crimson-red or beefy-red conjunctival appearance was evident throughout the first 72-hours after instillation. Very-slight or slight chemosis and slight or moderate discharge were apparent during this time. From 24-hours after instillation scattered or diffuse areas of opacity covering up to three quarters of the corneal surface were evident. Iritis was apparent 72-hours after instillation.
Other effects:
One week after instillation (Days 8 and 9) injection of the conjunctival blood vessels, scattered or diffuse area of opacity covering up to a quarter of the corneal surface and an area of pannus were evident. Pannus is regarded as an irreversible effect, consequently the study was terminated after the Day 9 assessment and no further animal was committed to the study.

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:
Pannus is regarded as an irreversible effect and under the criteria of the Globally Harmonised System of classification (United Nations 2005 and more recent revisions) as adopted by the European Commission (European Communities Regulation 1272/2008) DMI was assigned to Category 1 (Irreversible effects on the eye).