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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct 1995 - Jan. 1996
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.42
Principles of method if other than guideline:
Six healthy New Zealand Albino rabbits, free from evidence of ocular irritation and corneal abnormalities, were dosed with the substance.
The test article (0.1 ml equivalent) was placed into the conjunctival sac of one eye of each rabbit. The eyes were not washed.
The eyes were examined and scored by the Draize technique days 1, 2 and 3. Body weights were recorded pretest.
The primary eye irritation score for each rabbit, each time period, was calculated.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
(2R,3R,4R,5R)-4-(acetyloxy)-5-(4-amino-5-fluoro-2-oxo-1,2-dihydropyrimidin-1-yl)-2-methyloxolan-3-yl acetate
EC Number:
605-260-4
Cas Number:
161599-46-8
Molecular formula:
C13 H16 F N3 O6
IUPAC Name:
(2R,3R,4R,5R)-4-(acetyloxy)-5-(4-amino-5-fluoro-2-oxo-1,2-dihydropyrimidin-1-yl)-2-methyloxolan-3-yl acetate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
White powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals were received from Ace Animals, Boyertown, PA on 4/25 and 5/02/95. Following a quarantine of at least one week, six healthy
New Zealand Albino rabbits, free from evidence of ocular irritation, were selected for this test from a larger group.

The animals were born the weeks of 2/12 through 2/26/95. The pretest body weight range was 2,2 - 2,6 kg.
The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed 1/cage in suspended cages.
Bedding was placed beneath the cages and changed at least three times/week. Fresh Purina Rabbit Chow (Diet #5321), supplied by Davis Feed
of Bucks County, Perkasie, PA was provided daily. Water was available ad libitum.

The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle and was kept clean and vermin free.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Contralateral eye served as a control
Amount / concentration applied:
0,1 ml equivalent
Observation period (in vivo):
Examination on days 1, 2 and 3
Number of animals or in vitro replicates:
6
Details on study design:
The test article (0,1 ml equivalent) was placed by syringe or syringe-type applicator into the conjunctival sac which was formed by gently
pulling the lower eyelid away from the eye.
After instillation, the lids were held together briefly to insure adequate distribution of the test article.
One eye of each rabbit was dosed.
The contralateral eye served as a control.

The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva on days 1, 2 and 3.
Ocular reactions were graded according to the numerical Draize technique.

The irritation potential was determined by counting the number of rabbits with positive irritation on days 1, 2 or 3.
Positive irritation is defined as any score for opacity or iritis, or 2 or more
for redness or chemosis.
The test article is an irritant if 4 or more rabbits had a positive score at any time period.

Body weights were recorded pretest.

The general health of the animals was monitored at each observation time.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: Day 3
Score:
ca. 0
Reversibility:
other: Not applicable
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: Day 3
Score:
ca. 0
Reversibility:
other: Not applicable
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: Day 3
Score:
ca. 0
Reversibility:
other: Not applicable
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: Day 3
Score:
ca. 0
Reversibility:
other: Not applicable
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: Day 3
Score:
ca. 0
Reversibility:
other: Not applicable
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: Day 3
Score:
ca. 0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
The test article is not an eye irritant as defined in 16 CFR 1500.42
Other effects:
Not applicable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: 16 CFR 1500.42
Conclusions:
The test article is not an eye irritant as defined in 16 CFR 1500.42