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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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
EC Number:
249-616-3
EC Name:
Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
Cas Number:
29420-49-3
Molecular formula:
C4HF9O3S.K
IUPAC Name:
potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot Number 2

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored in original container at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Inc.
- Age at study initiation: Approximately 16 weeks old
- Weight at study initiation:
- Housing: Animals were individually housed in stainless steel cages
- Diet (e.g. ad libitum): Tekland Certified Rabbit Diet #8630 provided at approximately 125g per day ad libitum
- Water (e.g. ad libitum): Filtered tap water ad libitum
- Acclimation period: Acclimated for a minimum of 7 days prior to study day 1

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16C to 22C
- Humidity (%):30% TO 70%
- Air changes (per hr): Ten or greater air changes per hour
- Photoperiod (hrs dark / hrs light): 12:12 hour light:dark cycle

IN-LIFE DATES: From: 9 June 2000 To: 29 June 2000

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 80 mg
Duration of treatment / exposure:
Left eye was exposed to 80 mg T-7485. Both eyes were held close for approximately 2 seconds
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 Females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Both eyes were flushed with approximately 5 mL of 0.9% saline
- Time after start of exposure: After 24-hour score was recorded

SCORING SYSTEM: Draize technique (Hackett, R.B., and McDonald, T.O, Eye Irritation, Dermatotoxicolocly, Fourth Edition, Marzulli, F.N. and Maibach, H.I.: 749-815, 1991)

TOOL USED TO ASSESS SCORE: Fluorescein staining

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Irritation parameter:
other: Cornea area
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Irritation parameter:
other: Conjunctivae redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Irritation parameter:
other: Conjunctivae discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Irritation parameter:
other: Cornea area
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Irritation parameter:
other: Conjunctivae redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Irritation parameter:
other: Conjunctivae discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Irritation parameter:
other: Cornea area
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Irritation parameter:
other: Conjunctivae redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Irritation parameter:
other: Conjunctivae discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Irritant / corrosive response data:
Maximum average ocular scores for 24- and 72-hours post-dose were 30 and 35, respectively. By definition, the findings at 24- and 72-hours will not maintain the categories of non-irritating, practically non-irritating, or minimally irritating. Ocular irritation scores at the 7-day reading were less than 10 (scores were 6, 4, and 30 for the three rabbits) for 67% of the rabbits. The seven-day mean score was 13. Ocular effects in one animal did not fully reverse by day 21.
Other effects:
- Lesions and clinical observations: At one hour post-dose, excessive lacrimation of the left eye was recorded in all three rabbits. The excessive lacrimation of the left eye persisted throughout the remainder of the study.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the results of the study, the test article is corrosive to the eyes of rabbits.
Executive summary:

The primary ocular irritation/corrosion potential of T-7485 was evaluated in three female New Zealand White rabbits. The study was based on OECD 405 (no year reported) and was certified GLP. Approximately 80 mg of test material, T-7485, was instilled unchanged to the conjunctival sac of the left eye of each rabbit by gently pulling the lower eyelid away from the eye; the right eye of each animal served as a control. Both eyes were held closed for approximately 2 seconds after administration to ensure adequate distribution of the test material. The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours postdose and daily on Days 5-21 using the Draize technique. After the examination at 24 hours postdose, both eyes of each rabbit were rinsed with approximately 5 mL of 0.9% saline. The Primary Irritation Index (PII) was calculated. Corneal opacity was observed in all animals at 1 hour postdose (scores: 1, n=2; 2, n=1) and cleared in 2/3 animals by 48 hours and 7 days postdose, respectively. The individual mean scores (24-72 hours) for corneal opacity were 0.33, 2.0, and 1.67. Iritis was observed in all animals at 1 hour postdose (scores: 1, n=1; 2, n=2) and cleared in 2/3 animals by Days 5 and 6, respectively. All individual mean scores (24-72 hours) for iritis were 1.0. Conjunctival redness was observed in all animals at 1 hour postdose (all scores: 2) and resolved in 2/3 animals by Day 10. The individual mean scores (24-72 hours) for conjunctival redness were 1.67, 2.0, and 2.0. Conjunctival chemosis was observed in all animals at 1 hour postdose (scores: 1, 2, and 4) and cleared in 2/3 animals by Days 7 and 8, respectively. The individual mean scores (24-72 hours) for conjunctival chemosis were 2.0, 2.0, and 2.67. Conjunctival discharge was observed in all animals at 1-72 hours (all scores: 3), Days 5-6 (scores: 2, n=2; 3, n=1), Days 7-12 (all scores: 1), Day 13 (scores: 1, n=2; 2, n=1), Days 14-17 (scores: 1, n=2; 3, n=1), and Day 18 (all scores: 1). Discharge resolved in 2/3 animals by Days 19 and 21, respectively. Ocular irritation still persisted in 1/3 animals on Day 21 (corneal opacity: 4, iritis: 2, redness: 2, chemosis: 3, discharge: 1). The highest mean PII was 36.33/110 at 1 and 48 hours postdose. Occular effects in one animal did not fully reverse by 21 days. Based on the results of the study, the test article is corrosive to the eyes of rabbits.