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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24. Nov - 18. Dec. 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Guideline:
other: MAFF Testing Guideline of 12 Nousan No. 8147
Version / remarks:
2000
GLP compliance:
yes
Remarks:
Landesanstalt für Pflanzenbau und Pflanzenschutz Rheinland Pfalz, Sep 2001

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., Vonnas, France
- Weight at study initiation: 3.12 - 3.22 kg
- Housing: individually in stainless steel wire mesh cages with grating, floor acrea: 3000 cm2
- Diet: Kliba-Labordiaet, about 130 g/animal per day
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 (2 females, 1 male)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with 3 to 6 ml of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 hours after application

SCORING SYSTEM: according to OECD guideline 405

TOOL USED TO ASSESS SCORE: daylight tubes "Lumilux" (L 58/860 Plus Eco 25x1, Osram, Germany)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Suppuration, contracted pupil, discharge of blood and injected scleral vessels in a circumscribed area or circular were noted during the observation period within the first 72 hours. All findings were fully reversible within 7 days at the latest.

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
The substance has to be classified as mildly irritating to eyes (Category 2B) according to GHS-criteria.
Executive summary:

An eye irritation test in rabbits was performed according to the method described in OECD guideline 405 (GLP, reliability 1). An amount of 0.1 ml of the test substance was applied to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48, 72 hours and 7 days after application. Slight corneal opacity, moderate iritis, moderate or severe conjunctival redness, slight to marked conjunctival chemosis and slight to severe discharge were observed during the course of the study. In addition suppuration, contracted pupil, discharge of blood and injected scleral vessels in a circumscribed area or circular were noted during the observation period.

The ocular reactions were reversible in all animals within 7 days after application. The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.4 for iris, 2.3 for conjunctival redness and 1.7 for chemosis. There was one animal with a mean score of 2.67 for redness, the other two animals were at 2 and 2.33.

Considering the described ocular reactions as well as the average score for irritation, the test substance shows a slight eye irritation potential under the test conditions chosen.