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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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP; equivalent or similar to OECD TG 405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
In general Draize scoring system and the regulations of the Federal Hazardous Substances Act are followed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Gary, Indiana
- Weight at study initiation: 2473 to 2787 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled conditions
- Humidity (%):controlled conditions

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
3 females, 3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE: no washing
SCORING SYSTEM: according to Draize system with further modifications: inclusion of 0.5 scores
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72h
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24/48/72h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24/48/72h
Score:
0.16
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24/48/72h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24/48/72h
Score:
0.16
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24/48/72h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24/48/72h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24/48/72h
Score:
0.16
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24/48/72h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 24/48/72h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 24/48/72h
Score:
0.16
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
3

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material TBPPI, is not irritating to the eyes as tested in rabbits.
Executive summary:

Three male and 3 female New Zealand White rabbits (obtained from Kuiper's Rabbit Ranch, Gary, Indiana) were used for this study. The rabbits weighed from 2473 to 2787 grams at the beginning of the study. The rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters. They were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals". The animals were conditioned for a period of 15 days prior to study initiation. Water and Purina Rabbit Chow were available ad libitum. Prior to test material administration, the eyes of each rabbit were examined with ultraviolet light following instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.

The rabbits received 0.1 mL of the test material. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout. The treated eyes were examined in accordance with the following schedule:

24 hours following instillation, 48 hours, 72 hours and 7 days. After 72 hours and 7 days, sodium fluorescein examinations were conducted. After grading the eye reaction, one drop of sodium fluorescein was instilled directly onto the corneal surface of each rabbit. After few seconds, excess stain was flushed from the corneal surface with dis tilled water and the eyes examined with ultraviolet light.

In 5 of 6 animals eyes weak redness and chemosis could be observed after 24 hours, which were reversible within 72 hours. Based upon the data obtained and in accordance with the requirements of the regulations of the Federal Hazardous Substances Act, the test material would not be considered a primary eye irritant.