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:
1989-11-02 to 1990-01-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
March, 1984
Deviations:
no
GLP compliance:
yes

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: male 14 weeks, females 15 weeks
- Weight at study initiation: male 2.8 kg, females 2.3 - 2.5 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen).
- Diet (e.g. ad libitum): ad libitum, Pelleted standard Kliba 341, Batch 48/89 and 49/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst)
- Water (e.g. ad libitum): ad libitum, Community tap water from Itingen
- Acclimation period: Four days under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per animal were placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article.

Duration of treatment / exposure:
Single instillation without rinsing
Observation period (in vivo):
21 days; reading intervals: 1, 24, 48 and 72 h, 14 and 21 days post-instillation
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
SCORING SYSTEM: The irritation was assessed according to the numerical scoring system provided by OECD guideline 405
TOOL USED TO ASSESS SCORE: Eye examinations were made with a slit-lamp 30 SLIM (C. Zeiss AG, Zuerich/Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel/Switzerland).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: score 3 at day 21
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: score 1 at day 21
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: score 1 at day 21
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritant / corrosive response data:
Corneal opacity was observed in all animals at any of the measuring intervals. Partly corrosion of the conjunctivae was observed in two animals from 24 hours to 7 days, and in one animal from 48 hours to 7 days after treatment. Yellow staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all animals 1 hour after treatment.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

24 h

 2/2/2

1/1/1

2/2/2 

 3/3/3

48 h

 3/3/3

 1/1/1

 2/2/2

 3/3/3

72 h

 3/3/3

 1/1/1

 2/2/2

 3/3/3

Average 24h, 48h, 72h

2.67/2.67/2.67 

 1/1/1

 2/2/2

 3/3/3

Reversibility*)

 n.

 n.c.

n.c. 

c. 

Average time (unit) for reversion

 21 (d) 

21 (d)  

21 (d)  

21 (d) 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of the study conducted according to OECD guideline 405, the test material was found to cause corrosive/irriversible effects to the rabbit eye. The mean scores for corneal opacity, iritis, conjunctival redness and chemosis from gradings at 24, 48 and 72 h were 2.67, 1, 2, 3in all three animals. Corneal opacity and conjunctival redness observed in all animals and iritis in one animal were not reversible up to the end of the 21-day observation period. Therefore, the test material fulfils the criteria for classification as eye corrosive Category 1 according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to cause serious eye damage.