Registration Dossier

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:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
None
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
None

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
None

Test system

Vehicle:
not specified
Controls:
other: other eye served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
3 days
Observation period (in vivo):
1, 24, 48 and 72 hours
Duration of post- treatment incubation (in vitro):
None
Number of animals or in vitro replicates:
3 (2 males & 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): remain unwashed- Time after start of exposure: 1, 24, 48 and 72 hours

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: over all at 24,48 and 72 hours
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(means score 2)
Time point:
other: over all at 24,48 and 72 hours
Score:
0.67
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
means score 3
Time point:
other: over all at 24,48 and 72 hours
Score:
0.33
Irritation parameter:
conjunctivae score
Max. score:
2
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: over all at 24,48 and 72 hours
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: over all at 24,48 and 72 hours
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: over all at 24,48 and 72 hours
Score:
0
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24,48 and 72 hours
Score:
0.67
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.67
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
1
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.33
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.33
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Irritation parameter:
iris score
Max. score:
1
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days.
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The irritation potential of the test material was judged to be mild, and therefore classified as non irritant.
Executive summary:

The purpose of this study was to determine the eye irritating potency of FAT 40554

The study was performed according to GLP methodology and OECD guideline 405; 92/69/EEC, B.5.

3 rabbits were used to performed the test (1 males and 2 females). 100 mg of FAT 40554 was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality.

The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 40554 according to the OECD scoring system.

FAT 40554 is considered to be non-irritant to the eyes rabbits.