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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:
Not applicable
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets basic scientific principles
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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.
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.
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.
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.