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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:
November 2006 to April 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
humidity out of range for protocol. No adverse effect on the study
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTDID 7145
- Physical state:Liquid
- Analytical purity:~ 94.5%
- Lot/batch no.:142072;43
- Expiration date of the lot/batch: 30 December 2007
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The netherlands
- Age at study initiation: 9-13 weeks
- Weight at study initiation:2095 to 2638
- Housing:Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 +/- 3 deg. C.
- Humidity (%): 28-68%
- Air changes (per hr):15

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE: after 24 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks:
24 hours
Remarks on result:
other: A weak conjunctival redness score of 1 (0-3) was observed in one animal at the 1 hour examination point. At the next examination at 24 hours, the redness was gone.
Remarks:
A weak conjunctival redness score of 1 (0-3) was observed in one animal at the 1 hour examination point. At the next examination at 24 hours, the redness was gone.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Immediately after dose administration (1 hour), irritation (redness) was observed in the conjunctivae of one animal which completely resolved within 24 hours. No further evidence of irritation was observed in any animal.
Other effects:
No mortality occured

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
non-irritating
Executive summary:

Acute eye irritation/corrosion potential of FC-770 (liquid, batch 142072:43) was evaluated in rabbits following OECD guideline No. 405 (2002) “Acute Eye Irritation/Corrosion.” A single dose of 0.1 mL undiluted test material was placed on the conjunctival sac of one eye of 3 male 6-week old New Zealand White Albino rabbits. The lower lid was gently pulled away from the eyeball for dosing and the lids were gently held together for approximately 1 second to prevent loss. The untreated eye of each animal served as the reference control. Animals were observed for eye irritation at approximately 1, 24, 48 and 72 hours after the instillation of the test substance. Immediately following the 24-hour observation a solution of 2% fluorescein in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Animals were euthanatized following the last observation. Immediately after dose administration, irritation (redness) was observed in the conjunctivae of one animal which completely resolved within 24 hours. No further evidence of irritation was observed in any animal. There were no observations of ocular corrosion or corneal epithelial damage in any animals. Based on these results FC-770 does not have to be classified and has no obligatory labeling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (New York and Geneva, 2003) and EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC).