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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was performed according to following guidelines: OECD 405 guideline, EPA Federal Register Vol.50, No. 188 , (Friday, September 27, 1985) and in compliance with the GLP Regulations.No significant deviations can be observed from the study guidelines, which could have an impact on the performed study. No data on purity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
purity not reported
Qualifier:
according to
Guideline:
other: EPA FR Vol.50, No.188 (September 27, 1985)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 6933-6-20
- Physical state: clear,yellow , viscous liquid
- Analytical purity: no data
- Lot/batch No.: 92-014
- Stability under test conditions: No visible change in the physical state of the test article during storage or administration
- Other: pH=9 (litmus paper)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Age at study initiation: 8-12 weeks (adult)
- Weight at study initiation: 2.670kg
- Housing: individually in cages sized in accordance with the "Guide.for the Care and Use of Laboratory Animalsw of the Institute of Laboratory Animal Resources, National Research Council.
- Diet (e.g. ad libitum): Purina Lab Rabbit Chow H., ad libitum
- Water (e.g. ad libitum):Fresh tap water, ad libitum
- Acclimation period:min.5d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 50% ±20
- Photoperiod (hrs dark / hrs light):12h dark/12h light


IN-LIFE DATES: From: 17 Feb 1993 To: 17 Feb 1993

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 mL/treated eye
Duration of treatment / exposure:
1 second
Observation period (in vivo):
1h
Number of animals or in vitro replicates:
One (1 ♀)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: observation
Draize and Ocular scores


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: Not applicable (NA)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h
Score:
40
Max. score:
80
Remarks on result:
other: Draize, degree of opacity, area involved
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h
Score:
10
Max. score:
10
Remarks on result:
other: Draize, degree of iritis
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
20
Max. score:
20
Remarks on result:
other: Draize, redness (3), chemosis (4), discharge (3)
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1h
Score:
70
Max. score:
110
Remarks on result:
other: Draize
Irritant / corrosive response data:
Vocalization occurred immediately after test article administration.
Due to the extreme ocular scores observed, the study was terminated at the study director's discretion after the 1-hour observation period.

Applicant's summary and conclusion

Interpretation of results:
other: severe irritant
Remarks:
Criteria used for interpretation of results: US EPA pesticides
Conclusions:
Based upon the observations made in the Primary Eye Irritation study, test article 6933-6-20, Project #92-014, was determined to be a severe irritant.
Executive summary:

Eye irritation of TETA was tested in one female rabbit. TETA was applied undiluted to the eye for 1 second. Vocalization occurred immediately after test article administration. Due to the extreme ocular scores observed, the study was terminated at the study director's discretion after the 1 -hour observation period.