Registration Dossier

Diss Factsheets

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:
guideline study

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
purity not reported
Qualifier:
according to guideline
Guideline:
other: EPA FR Vol.50, No.188 (September 27, 1985)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, polyethylenepoly-, triethylenetetramine fraction
EC Number:
292-588-2
EC Name:
Amines, polyethylenepoly-, triethylenetetramine fraction
Cas Number:
90640-67-8
Molecular formula:
C6H18N4, C8H20N4
IUPAC Name:
Amines, polyethylenepoly-, triethylenetetramine fraction
Test material form:
liquid

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: Purina Lab Rabbit Chow H., ad libitum
- Water: Fresh tap water, ad libitum
- Acclimation period:min. 5d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- 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:
animal #1
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: study was terminated after 1 hour due to severe effects (score 2)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: study was terminated after 1 hour due to severe effects (score 2)
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: study was terminated after 1 hour due to severe effects (score 3)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Reversibility:
not reversible
Remarks on result:
other: study was terminated after 1 hour due to severe effects (score 4)
Irritant / corrosive response data:
Vocalization occurred immediately after test article administration. Extreme positive ocular response for the cornea, iris and conjunctivae were observed at the 1 hour observation period. A red oculare discharge was also observed at this observation period.
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: CLP/EU GHS Category 1 (H318) according to Regulation (EC) No 1272/2008
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 the test substance was tested in one female rabbit. The test substance 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.