Registration Dossier
Registration Dossier
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EC number: 292-588-2 | CAS number: 90640-67-8
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- 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
- 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
Constituent 1
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.
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