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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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1998
Report Date:
1999

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)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Pa 243/244-22 bei 70 Grad getr.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animal species / strain quality: Rabbit/New Zealand White
Origin: Dr. K. Thomae GmbH, Biberach, FRG
Age of the animals: Young adult animals
Acclimatization period: at least for 1 week.
Housing: Stainless steel wire mesh cages with grating
Room temperature: 20 - 24 °C
Relative humidity: 30 - 70 %.
Day/night rhythm: 12 h/12 h (6.00 a.m. - 6.00 p.m.I 6.00 p.m. - 6.00 a.m.)
Type of cage: Stainless steel wire mesh cages with grating, floor area: 3000 cm2
No. of animals per cage: Single housing.
Animal identification: Ear tattoo
Bedding: No bedding in the cages; wood shavings in the waste trays.
Drinking water: About 250 ml tap water per animal per day
Diet: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland, (about 130 g per animal per day)

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml bulk volume
(about 26 mg of the comminuted test substance)
Duration of treatment / exposure:
The test substance was applied in a single dose to the conjunctival sac of the right eyelid; the substance was washed out with tap water about 24 hours after application (before 24 hour reading).
Observation period (in vivo):
1 h, 24 h, 48 h, 72 h, 8 d and 15 d after application.
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
Both eyes of the animal(s) were examined before application of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used in the study.
Route of application: The test substance was applied in a single dose to the conjunctival sac of the right eyelid; the substance was washed out with tap water about 24 hours after application (before 24 hour reading).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 15 d
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 15 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h

Any other information on results incl. tables

Individual eye scores

Animal No 1

Time point

Cornea

Iris

Conjunctiva (Redness)

Chemosis

After 24 hours

0

0

1

0

After 48 hours

0

0

1

0

After 72 hours

0

0

1

0

Mean (24-72 Hrs)

0

0

1

0

 

Animal No 2

Time point

Cornea

Iris

Conjunctiva (Redness)

Chemosis

After 24 hours

0

0

2

1

After 48 hours

0

0

1

0

After 72 hours

0

0

1

0

Mean (24-72 Hrs)

0

0

1.33

0.33

 

Animal No 3

Time point

Cornea

Iris

Conjunctiva (Redness)

Chemosis

After 24 hours

0

0

2

0

After 48 hours

0

0

2

0

After 72 hours

0

0

2

0

Mean (24-72 Hrs)

0

0

2

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance Palanil Gelb HM f. ber. t. does not give indication of an irritant property to the eye.
Executive summary:

An eye irritation study was carried out with Palanil Gelb HM f. ber. t. in NZW rabbits as per OECD Guideline 405. The potential of Palanil Gelb HM f. ber. t. to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits, subjected to a single ocular application of 0.1 ml bulk volume (about 26 mg) of the test substance. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and for iris, 1.4 for conjunctival redness and 0.1 for chemosis. The findings were reversible in all animals within 15 days after application; thus the study was terminated. Symptoms observed and described in the respective observations together with the mean scores for irritation do not indicate an irritant property of the test substance to the eye. Under the test conditions chosen and considering the described findings Palanil Gelb HM f. ber. t. does not give indication of an irritant property to the eye.