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
Reliability:
1 (reliable without restriction)
Justification for type of information:
Note that this is old data from testing done in 1996.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
F2 Chemicals Ltd internal identifier: L40092

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Acclaimised at least 5 days, housed in gril-bottomed metal cages, fed antibiotic-free diet and mains water, kept at 17-21°C 44-65% relative humidity

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Single exposure directly to right eye
Observation period (in vivo):
72 hour
Number of animals or in vitro replicates:
3

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
other: Modified Kay and Calandra scale
Basis:
mean
Time point:
other: 1 hr
Score:
ca. 0
Max. score:
0
Irritation parameter:
other: Modified Kay and Calandra scale
Basis:
mean
Time point:
other: 24 hr
Score:
ca. 0
Max. score:
0
Irritation parameter:
other: Modified Kay and Calandra scale
Basis:
mean
Time point:
other: 48 hr
Score:
ca. 0
Max. score:
0
Irritation parameter:
other: Modified Kay and Calandra scale
Basis:
mean
Time point:
other: 72 hr
Score:
ca. 0
Max. score:
0
Irritant / corrosive response data:
"There were no apparent signs of irritation in the treated eye of any animal throughout the 72 hour observation period.
The maximum mean irritation score was 0.0."

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
"Under the conditions of this study, the test article, FLUTEC PC6, is considered to be non irritating to the eye of the albino rabbit."
Executive summary:

"Under the conditions of this study, the test article, FLUTEC PC6, is considered to be non irritating to the eye of the albino rabbit."