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Diss Factsheets

Administrative data

eye irritation, other
OECD 405
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jul 10 -24, 2007
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to Good Laboratory Practice (GLP) and followed the OECD guideline for testing of Chemicals 405.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
Cas Number:
Molecular formula:
Test material form:
other: solid

Test animals / tissue source

New Zealand White
Details on test animals or tissues and environmental conditions:
Strain: Albino rabbit, Crl:KBL(NZW), female (f) Source: Charles River Wiga GmbH, KifßleggAge: about 14-15 weeksMean weight: 3,76 kg

Test system

unchanged (no vehicle)
not required
Amount / concentration applied:
0,1 g
Observation period (in vivo):
1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 8 of the experimental part.
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
-- Identification and adaptationHealthy rabbits were allocated to the study group. The animals were kept in the experimental room for more than 7 days to allow for acclimatization. Each animal was uniquely identified by a tattoo in the ear displaying the animal number. Individual cage cards were affixed to each cage displaying the study number, test material, day of treatment, and animal number.-- Assignment3 female rabbits were used for this study.-- Housing and dietAll rabbits were housed in an air-conditioned room of about 28 m^2 in the Institute of Toxicology. Lighting was controlled by a timer to provide a 12-hour light and a 12-hour dark regime.They were kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm^2, a shelter with an integrated sitting board of about 1820 cm^2; overall height: 60 cm) with plastic grids placed on mobile racks. The collection pans underneath the cages were cleaned at least three times a week. The cages were cleaned before the start of the study.Temperature and relative humidity were measured using a thermohygrograph. The room temperature varied from 20 to 22 °C and the relative humidity from 50 to 64 %. The rabbits received diet for rabbits No. 814, Eberle Nafag ad libitum, and fresh tap water from Makrolon drinking bottles at least three times a week.The diet is checked periodically according to the specifications of the manufacturer by an independent laboratory, approved by the German government. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.The drinking water is periodically analyzed according to the German regulations for human drinking water.-- PreparationBefore the application, the test material was ground in a mortar using a pestle.–- Administration and dose levelTo ensure that only rabbits with normal eyes were included in the study, approximately 24 hours before treatment ophthalmological examinations were performed after instillation of a 0.15 % fluorescein solution (Dr. Thilo & Co.) using an ophthalmoscope according to Eisenhut (Basel). Animals with eye defects, injury or irritation were excluded.0.1 g test material was instilled into the conjunctival sac of the left eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test material was placed. The right eye remained untreated and served as control. After instillation, the eyelids were closed for about 30 seconds.-- Observation for clinical symptomsThe rabbits were examined for eye irritation and for changes in behavior and general condition 1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 8 of the experimental part.Eye changes were evaluated according to the DRAIZE- , OECD- and EEC recommendations.-- Evaluation of eye reactions- Cornea ScoresA) Opacity-degree of density (area most dense taken for reading)No ulceration or opacity 0Scattered or diffuse areas of opacity (other than slight dullingof normal lustre), details of iris clearly visible 1Easily discernible translucent area, details of iris slightly obscured 2Nacrous area, no details of iris visible, size of pupil barely discernible 3Opaque cornea, iris not discernible through the opacity 4B) Area of cornea involved not evaluated (Rating according to the DRAIZE method)- IrisA) Normal 0 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1 No reaction to light, hemorrhage, gross destruction (any or all of these) 2 - Conjunctivae ScoresA) Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)Blood vessels normal 0Some blood vessels definitely hyperemic (injected) 1Diffuse, crimson color, individual vessels not easily discernible 2Diffuse beefy red 3B) Chemosis: lids and/or nictating membranesNo swelling 0Any swelling above normal (includes nictating membranes) 1Obvious swelling with partial eversion of lids 2Swelling with lids about half closed 3Swelling with lids more than half closed 4C) Discharge (Rating according to the DRAIZE method ) No discharge 0 Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1Discharge with moistening of the lids and hairs just adjacent to lids 2Discharge with moistening of the lids and hairs, and of a considerable area around the eye 3Mean score of all animals = Mean grading for irritations of cornea, iris, and conjunctivae per time pointMean score per animal = Mean grading for each animal of irritations of cornea, iris, and conjunctivae (1, 24, 48, and 72 hours after application)Maximum value = Maximum grading of a sign of irritation within a period

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Time point:
other: 24, 48, 72 h
Max. score:
Irritation parameter:
cornea opacity score
Time point:
other: 24, 48, 72 h
Max. score:
Irritation parameter:
conjunctivae score
Time point:
other: 24, 48, 72 h
Max. score:

Any other information on results incl. tables

All animals survived the observation period. Body weight development of the treated rabbits was inconspicuous.

No signs of clinical toxicity were detected. No signs of irritation were observed at the cornea or iris. All animals showed redness (score 1) and discharge (score 1) one hour after instillation of the test material. No abnormalities were detected in the untreated eyes.

Eve irritation of all animals (mean score):

  24 h  48 h  72 h 
Cornea (mean /max) 0/0  0/0  0/0
 Iris (mean / max)  0/0  0/0  0/0
 Conjunctivae (mean / max)  0/0  0/0  0/0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated informationCriteria used for interpretation of results: other: CLP
No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 (CLP).
Executive summary:


The purpose of this primary eye irritation assay was to provide information on possible health hazards in case of acute eye contact with a test material and serve as a rational basis for risk assessment to the eye irritating potential of the test item in man.

Study Design

To test for eye irritation a test according to the OECD-Guidelines for Testing of Chemicals No. 405, the annex to Directive 92/69 EEC, and the recommendations of DRAIZE (1959) was performed.


No signs of irritation were observed at the cornea or iris. One hour and 24 hours after treatment, the conjunctivae showed redness (score 1) in two animals. Furthermore, discharge (score 1) was seen one hour after treatment. Thereafter no signs of irritation were observed. The untreated eyes were unchanged.


No eye irritating potential could be detected, thus the test material should not be classified as eye irritant according to EU Regulation No. 1272/2008 (CLP).