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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:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Version / remarks:
according to 40 CFR Part 792
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Purity 90%, Dark Yellow Liquid, Lot 31018BC

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
4 males and 2 females
Adult rabbits received from Davidson's Mill Farm, South Brunswick, NJ
All animals were housed singly in suspended stainless steel caging with mesh floors which conform to size recommendations.
Litter paper was placed beneath the cage and was changed at least three time per week.
Room temperature was kept at 68-70oF
12 hour light/dark cycles
Acclimation period of 14 days

Animals were given pelleted Purina Rabbit Chow and Filtered Water was supplied ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
One-tenth of a millileter
Duration of treatment / exposure:
One eye of each rabbit received the test substance and was applied to the eye for 1 second before releasing
Observation period (in vivo):
Animals were observed for 7 days for signs of eye irritation
Number of animals or in vitro replicates:
6
Details on study design:
6 rabbits recieved one-tenth of a millilter of the test substance instilled into the conjunctival sac of the right eye by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about 1 second before releasing, to prevent loss of the test substance. The other eye of each rabbit remained untreated to serve as a control. Elizabethan collars were placed on each rabbit and they were returned to their cages. Ocular irritation was evaluated using a high-intensity white light at 1,24, 48, and 72 hours and 4 and 7 days post instillation. Twenty four hours after instillation, collars were removed. The animals were observed for signs of toxicity, behavioral changes, and mortality at least once daily during the test period.

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Max. score:
110
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
Mildly irritating to eyes

Any other information on results incl. tables

Results: Eye Irritation,

Wnorowski, 1994

Time: Incidence of Irritation
Hours Corneal Opacity Iritis Conjunctival Irritation
1

0/6

2/6 5/6
24

0/6

1/6 6/6
48

0/6

1/6 6/6
72

0/6

1/6 6/6
Days    
4

0/6

1/6 6/6
7

0/6

0/6 0/6
       

Mean Scores per Timepoint

MMTS (Draize)

Time: MMTS   
Hours 5544 5545 5546 5547 5548 5549 Mean MMTS
1 17 12 15 10 8 10 12
24 12 8 17 12 14 14 12.8
48 6 4 17 8 10 8 8.8
72 8 4 17 8 10 6 8.8
Days    
4 8 4 17 8 10 6 8.8
7 0 0 0 0 0 0 0
               

According toKay and Calandra,J. Soc. Cos. Chem. 13: 281-289, 1962)

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
The test material was tested in a study for eye irritation in vivo. Mild conjunctivitis was observed in all animals through day 4, and mild iritis was observed in 2 of 6 animals through day 4. The substance is classified as mildly irritating to the eye.