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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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

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:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation:15 weeks (male); 14 weeks (females)
- Weight at study initiation:2.8 to 3.2 kg
- Housing:Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with autoclaved wood (02/2000, RCC Ltd, Füllinsdorf) and haysticks for gnawing.
- Diet (e.g. ad libitum):Pelleted standard Provimi Kliba 3418 rabbit maintenance diet aaf libitum (batch no. 30/00) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis are archived at RCC Ltd, Hingen.
Haysticks (QS no. 137/00 and 168/00) provided by Eberle Nafag AG, CH-9200 Gossau.
- Water (e.g. ad libitum):Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period:Six to seven days under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-23.5
- Humidity (%):approximately 44-79
- Air changes (per hr):10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours dark.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
about one second
Observation period (in vivo):
1 hr, 24 hrs, 48 hrs,72 hours, 7 days
Number of animals or in vitro replicates:
3
Details on study design:
TREATMENT
The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, FAT 60'253/A was placed in the conjunctival sac of the left eye of one male animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. As no severe irritant occular lesions occured after 24 hours, the other two animals were treated in the same way as the first animal 24 hours later. The treated eyes were not rinsed after instillation.

SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, as well as 7 days after application.
When present, corrosion and/or staining of sclera and cornea by the test item were recorded and reported. Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.67
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
1.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
2
Remarks on result:
other: Max. duration: 3 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: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Max. duration: 1 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 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Max. duration: 0 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 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 0 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 7 days
No corrosion of the cornea was observed at any of the reading times.
Other effects:
COLORATION:
Yellow remnants were observed in the eye or conjunctival
sac of all animals. No coloration was noted.

BODY WEIGHTS : The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based upon the referred classification criteria (EEC Commission Directive 93/21 /EEC of April 27,1993), FAT 60'253/A is considered to be "not irritating" to the rabbit eye.
Executive summary:

The primary eye irritation potential of FAT 60'253/A was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.89 redness of the conjunctivae and grade 0.22 Chemosis of the conjunctivae.

No corneal and iridal effects were observed. Slight to moderate redness of the conjunctivae and/or nictitating membrane was recorded for all animals from 1 to 48 hours after treatment. The redness diminished and cleared in two animals at 72 hours and in the third animal by day 7. Moderate (obvious, with partial eversion of the lids) swelling was seen in two animals at the 1-hour examination and decreased at 24 hours before disappearing at 48 hours. Moderate reddening of the sclera was observed in all animals at the 1-hour examination. The scleral redness diminished to slight at 24 hours and cleared in one animal by 48 hours and in two animals by 72 hours. A slight watery discharge was noted in one animal at the 1-hour reading.

No staining of the treated eyes by the test item was observed.

Yellow remnants of the test item were seen in the treated eyes of all animals at the 1-hour examination.

No corrosion was observed at any of the measuring intervals.

All eye reactions were clear within 7 days after treatment.

Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), FAT 60'253/A is considered to be "not irritating" to the rabbit eye.