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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Ceraphyl 55
- Date received: 01/28/04
- Physical state: Clear light yellow liquid
- Lot/batch No.: P#1743
- Storage condition of test material: Room temperature and humidity
- Sample preparation: The test article was used as received

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Date of birth: 11/02/03
- Data received: 01/21/04
- Weight at study initiation: 2.8-3.1
- Housing: The animals were housed 1/cage in suspended cages
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321)was provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature and humidity: Controlled
- Humidity (%):
- Photoperiod (hrs dark / hrs light): 12 hr dark/12 hr light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24 48 72 hours post dose
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
Prior to start the test, rabbits were checked for ocular irritation and corneal abnormalities. A 0.1 ml aliquot of the test article was placed into the conjunctival sac on one eye of each rabbit using a syringe. The lids of the eye were hold together for approximately one second to prevent test material loss. The eyes were observed using a flashlight equipped with a high intensity bulb. The observations included irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours. Sodium fluorescein dye procedure was used at the 24-hour time point observation interval. Ocular reactions were scored according to the Draize numerical technique.
At the end of the study, animals were sacrificed using CO2.
Bodyweights were recorded before the test.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 1 hour
Score:
10
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 24 hours
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 48, 72 hours
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 1 hour
Score:
10
Max. score:
110
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 1 hour
Score:
10
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 24 hours
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 48, 72 hours
Score:
0
Max. score:
110
Irritant / corrosive response data:
No corneal opacity or iritis. Conjunctival irritation was noted in 3/3 eyes. Effects were still evident in 2/3 animals at 24 hrs but had resolved by 48 hrs.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: EU
Conclusions:
The test material Ceraphyl 55 is considered to be minimally irritant under the condition of this study, so the level and frequency of the effects did not meet the criteria for classification as eye irritation.
Executive summary:

The test material Ceraphyl 55 was tested in 3 New Zealand White rabbits. A 0.1 ml aliquot of the test article was placed into the conjunctival sac on one eye of each rabbit using a syringe. The eyes were observed using a flashlight equipped with a high intensity bulb. The observations included irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours. Sodium fluorescein dye procedure was used at the 24-hour time point observation interval. Ocular reactions were scored according to the Draize numerical technique. The results show no evidence of corneal opacity or iritis. A conjunctival irritation was noted in 3/3 animals 1 hr after treatment. Effects were still evident in 2/3 animals at 24 hrs but were fully reversible within 48 hours. In conclusion, Ceraphyl 55 is considered to be a minimal irritant, but not corrosive, under the condition of this study.