2,2'-iminodi(ethylamine)

Eye irritation

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: Meets basic scientific principles

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Test material was applied to the eye of a rabbit and the rabbit was observed for 8 days.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-iminodi(ethylamine)

EC Number:

203-865-4

EC Name:

2,2'-iminodi(ethylamine)

Cas Number:

111-40-0

Molecular formula:

C4H13N3

IUPAC Name:

bis(2-aminoethyl)amine

Details on test material:

- Name of test material (as cited in study report): Diethylenetriamine; Hercules Grade DETA
- Physical state: liquid; Color: pale yellow; Odor: ammonical
- Composition of test material, percentage of components: 0.5% MEA; 8% AEP and 91.5% DETA
Boiling point: 199 ºC @ 760 mmHg

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Young, male albino rabbits

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):Report indicated that it followed standard practices which would be 2 drops into each eye..
- Concentration (if solution): undiluted

Duration of treatment / exposure:

Report indicated that it followed standard practices which would be right eye washed within 30 sec of exposure, left eye unwashed

Observation period (in vivo):

Eight days

Number of animals or in vitro replicates:

One

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Report indicated that it followed standard practices which would be one eye yes; the other eye no (both eyes are examined with fluorescein after 1 hour)
- Time after start of exposure: right eye washed within 30 sec of exposure
SCORING SYSTEM:evaluated pain, conjunctival response, corneal response (before and after staining) and internal effects. Responses were graded on a scale of 1-6 (no response to severe response).


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: fluorescein stain was used after 1, 24 and 48 hours and after 8 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

other: mean 1-3

Time point:

other: 1, 24, 48 hour

Score:

6

Max. score:

6

Reversibility:

not reversible

Remarks on result:

other: Washed and not washed. Initially the conjunctiva of both eyes were severely inflamed and swollen. These membranes were edematous one hour later.

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

Both washed and not washed eye

Time point:

other: approximately 8 days

Score:

5.5

Max. score:

6

Reversibility:

not reversible

Remarks on result:

other: Washed and not washed. Initially the conjunctiva of both eyes were severely inflamed and swollen. These membranes were edematous one hour later. These conditions began to subside in the washed eye after 8 days.

Results 3

Irritation parameter:

cornea opacity score

Basis:

other: mean 1-3 (Washed cornea before stain)

Time point:

other: 1, 24, 48 hours

Score:

4.33

Max. score:

5

Reversibility:

not reversible

Remarks on result:

other: The washed cornea was 50% opaque one hour post-instillation; 24 hours later the washed cornea was only cloudy.

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 hour

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: The unwashed eye was completely opaque one hour post-instillation; 24 hours later the unwashed eye remained opaque for the duration of the test. Examination of the unwashed eye showed the cornea was destroyed.

Irritant / corrosive response data:

This study indicates DETA is corrosive to the eye of the rabbit.

Other effects:

Not applicable

Any other information on results incl. tables

DETA produced indications of moderate pain when instilled into the eyes of a rabbit. Initially the conjunctiva of both eyes were severely inflammed and swollen. These membranes were edematous one hour later. These conditions persisted in the unwashed eye for the duration of the test, but began to subside in the washed eye after 8 days. The washed cornea was 50% opaque while the unwashed eye was completely opaque one hour post-instillation; 24 hours later the washed cornea was only cloudy, but the unwashed eye remained opaque for the duration of the test. Examination of the unwashed eye showed the cornea was destroyed. The retina of the unwashed eye was severely damaged. There were no internal effects of the washed eye.

Applicant's summary and conclusion

Conclusions:

This study indicates DETA is corrosive to the eye of the rabbit.

Executive summary:

DETA produced indications of moderate pain when instilled into the eyes of the rabbit. Initially the conjunctiva of both eyes were severely inflamed and swollen. These membranes were edematous one hour later. These conditions persisted in the unwashed eye for the duration of the test, but began to subside in the washed eye after 8 days. The washed cornea was 50% opaque while the unwashed eye was completely opaque one hour post-instillation; 24 hours later the washed cornea was only cloudy, but the unwashed eye remained opaque for the duration of the test. Examination of the unwashed eye showed the cornea was destroyed. The retina of the unwashed eye was severely damaged. There were no internal effects of the washed eye.