Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 June 1988 to 25 August 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): XRD-498

- Physical state: white powder
- Analytical purity: 99.6%

- Lot/batch No.: AGR 240043

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc, Denver PA

- Weight at study initiation: 2.7 to 3.3 kg
- Housing: individually
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period:2 weeks

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g aliquot


Duration of treatment / exposure:
one time application into the conjunctival sac of the right eye
Observation period (in vivo):
1, 24, 48, and 72 hours post-instillation
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no



SCORING SYSTEM: see table in "any other information" section


TOOL USED TO ASSESS SCORE: penlight

Results and discussion

In vivo

Irritant / corrosive response data:
see table in "remarks on results" section
Other effects:
no information

Any other information on results incl. tables

XRD-498: Primary Eye Irritation Study in New Zealand White Rabbits
Observation Time Animal Number Conjunctivae Corneal Opacity Reddening of the Iris
Redness Chemosis Discharge
one hour 88A3774 1 1 0 0 1
88A3775 1 1 0 0 1
88A3776 1 1 0 0 0
88A3777 1 1 0 0 1
88A3778 1 1 0 0 1
88A3779 1 1 0 0 1
24 hours 88A3774 0 0 0 0 0
88A3775 0 0 0 0 0
88A3776 0 0 0 0 0
88A3777 1 0 0 0 0
88A3778 1 1 0 0 0
88A3779 0 0 0 0 0
48 hours 88A3774 0 0 0 0 0
88A3775 0 0 0 0 0
88A3776 0 0 0 0 0
88A3777 0 0 0 0 0
88A3778 0 0 0 0 0
88A3779 0 0 0 0 0
72 hours 88A3774 0 0 0 0 0
88A3775 0 0 0 0 0
88A3776 0 0 0 0 0
88A3777 0 0 0 0 0
88A3778 0 0 0 0 0
88A3779 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
no data
Remarks:
Migrated information
Conclusions:
Aliquots of 0.1g of XRD-498 were instilled once into the conjunctival sac of the right eye of six New Zealand White rabbits. Slight conjunctival redness, slight conjunctival chemosis and reddening of the iris were observed up to 24 hours post-instillation. There were no signs of ocular irritation in any of the animals at the 48 or 72 hours post-treatment observations. There were no signs of corneal opactiy at any time during the study.
Executive summary:

Aliquots of 0.1g of XRD-498 were instilled once into the conjunctival sac of the right eye of six New Zealand White rabbits. Slight conjunctival redness, slight conjunctival chemosis and reddening of the iris were observed up to 24 hours post-instillation. There were no signs of ocular irritation in any of the animals at the 48 or 72 hours post-treatment observations. There were no signs of corneal opactiy at any time during the study. XRD-498 is not considered an eye irritant.