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:
17 - 28 Feb 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted Feb 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
EEC Directive 92/69/EEC, Dez 1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
(SPF)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman Instituute B.V., Someren, Netherlands
- Age at study initiation: 8, 17 or 18 weeks
- Housing: individually in cages with perforated floors
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, Netherlands), approx. 100 g per day; hay (BMI, Helmond, Netherlands) once a week
- Water: tap water diluted with decalcified water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 63.9 ± 2.6 mg (approx. 0.1 mL)
Duration of treatment / exposure:
single treatment without washing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

OBSERVATIONS: Animlas were observed for mortality/viability twice daily and for signs of toxicity at least once a day. Body weight was determined on the day of treatment prior to instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48
Irritant / corrosive response data:
Iridic irritation grade 1 was observed in one animal 1 hour after instillation. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 72 hours in one animal and within 7 days in the other two animals. No corneal opacity or corneal epithelial damage was observed in any of the animals.
Other effects:
- Other observations: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1. Results of eye irritation test

Alteration

Animal No.

Time (h)

 

24

 

48

 

72

mean 24/48/72 h

reversible within

Cornea

1

0

0

0

0.0

n.a.

2

0

0

0

0.0

n.a.

3

0

0

0

0.0

n.a.

Iris

1

0

0

0

0.0

n.a.

2

0

0

0

0.0

n.a.

3

0

0

0

0.0

n.a.

Conjunctivae Redness

1

2

1

1

1.3

7 d

2

1

1

0

0.7

72 h

3

2

2

1

1.7

7 d

Conjunctivae Chemosis

1

1

0

0

0.3

48 h

2

1

0

0

0.3

48 h

3

1

0

0

0.3

48 h

n.a.: not applicable

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.