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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:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study equivalent to OECD guideline 405.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): UCAR® Ester EEP (Ethyl 3-Ethoxypropionate)
- Physical state: liquid
- Analytical purity: 99% (GC)

- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored by the attached system at one hour, approximately 4 hours, one day, 2 days , 3 days and 7 days after dosing. Additional readings are made, if necessary , at 14 and 21 days. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.

Duration of treatment / exposure:
one second
Observation period (in vivo):
one hour; 4 hours; 24 hours; 48 hours; 72 hours; 7 days
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: scoring scale

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Reversibility:
other: no effects observed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Reversibility:
other: no effects observed
Irritant / corrosive response data:
Instillation of 0.1 ml of the sample into rabbit eyes resulted in no corneal injury (opacity) in any of the 6 animals. Iritis was apparent in 3 eyes and minor conjunctival irritation delevoped in all 6 rabbits. Most animals had substantial ocular discharge. By 24 hours, all eyes had a normal appearance.
Other effects:
none

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was no corneal injury in any of 6 eyes, tansient iritis in 3, minor transient conjunctival irritation in 6 from 0.1 ml Ethyl 3-Ethoxypropionate all healed at 24 hr. All scores for cornea, iris, conjunctivae and chemosis were 0 after 24, 48 and 72 hours.
Executive summary:

Instillation of 0.1 ml of UCAR Ester into rabbit eyes produced minor transient irritation which did not involve the cornea (opacity) in any of the 6 animals. Iritis was apparent in 3 eyes and minor conjuctival irritation developed in all 6 rabbits. Most animals had substantial ocular discharge. By 24 hours, all eyes had a normal appearance.