Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
other: TSCA
Principles of method if other than guideline:
A single dose was introduced into the lower conjuctival sac of the right eye of Albino rabbits (4 males and 2 females).
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material: Tri-isobutylphosphate
- Physical state: clear liquid
- Analytical purity: 99.7%
- Lot/batch No.: NBP 983659
- 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: Summit View Farm Hazleton, Pennsylvania
- Age at study initiation: at least 8 weeks old
- Weight at study initiation: not specified
- Housing: individually housed. Cages: suspended, stainless steel
- Diet (ad libitum): Lab Rabbit Chow HF (Purina # 5326)
- Water (ad libitum): automatic watering system. Municipal water supply
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6-21.1 °C
- Humidity (%): 30-70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
4 males and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing
- Time after start of exposure: approximately 24 hours after application, the treated eyes were rinsed to remove any residual test material

SCORING SYSTEM:
At each interval, the treated and control eyes were examined and scored for ocular reactions according to the Draize scale

TOOL USED TO ASSESS SCORE:
Fluorescein dye was used to confirm presence or absence of corneal ulceration in treated eyes starting with the 24 hour observation and at each subsequent observation until there was no stain retention for two observations .

Results and discussion

In vivo

Results
Remarks on result:
other: See remark in Irritant/corrosive response data
Irritant / corrosive response data:
Tri-isobutylphosphate produced mild to moderate, transient ocular irritation. Irritation consisted primarily of conjunctival irritation (redness, chemosis, discharge) with the most severe effects occuring at one hour. One animal exhibited iridial changes at one hour. No corneal changes were seen. Four of the six animals were free of ocular irritation within 24 hours after instillation of the test material; the remaining two animals were free of ocular irritation within 48 to 72 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met