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Diss Factsheets

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:
05 March, 1985 to 27 March, 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
Test substance: FAT 45082/D
Batch No.: EN 35713.42
Physical properties: powder; dispersible in water; pH: 8.5 (1 g/L water)
Validity: June 1989
Safety precautions: gloves and face masks
Test material received: February 11, 1985

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks old
- Weight at study initiation: 2 to 3 kg
- Housing: The animals were housed individually in metal cages, identified with individually numbered ear tags.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod: 12 hours light cycle day

IN LIFE PHASE: From: 05 March, 1985; To: 08 March, 1985

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
0.1 g of FAT 45082/D was placed into the conjunctival sac of the right 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 material. The left eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 45082/D.

SCORING SYSTEM: according to the OECD scoring system

TOOL USED TO ASSESS SCORE: A slit-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
None
Other effects:
No effect on body weight gains was seen.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 45082/D has no primary eye irritation potency in albino rabbits.
Executive summary:

The eye irritation potential of FAT 45082/D was evaluated in a study conducted according to OECD Guideline 405. 0.1 g of FAT 45082/D was placed into the conjunctival sac of the right eye of each of 3 male rabbits, 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 material. The left eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 45082/D. Slight conjunctival redness and chemosis were reported at 1 hour observation, which was found to have reversed by 24 hours. Because no reactions were observed at 72 hours after instillation of FAT 45082/D, the test was ended after the 72 hours evauation. Based on these findings, it can be concluded, that FAT 45082/D has no primary eye irritation potency in albino rabbits.