Trientine

Eye irritation

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:

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 guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

purity not reported

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EPA FR Vol.50, No.188 (September 27, 1985)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Trientine

EC Number:

203-950-6

EC Name:

Trientine

Cas Number:

112-24-3

Molecular formula:

C6H18N4

IUPAC Name:

N,N'-bis(2-aminoethyl)ethane-1,2-diamine

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

Results

Results 1

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1h

Score:

10

Max. score:

10

Remarks on result:

other: Draize, degree of iritis

Results 3

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)

Results 4

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.