Registration Dossier
Registration Dossier
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EC number: 605-146-4 | CAS number: 158451-78-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- study duration was 72h instead of 21 days
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,6-Hexanediamine, N1,N1,N6,N6-tetramethyl-, propoxylated (>1 < 4,5 mol PO)
- EC Number:
- 605-146-4
- Cas Number:
- 158451-78-6
- Molecular formula:
- C16H38N2O2
- IUPAC Name:
- 1,6-Hexanediamine, N1,N1,N6,N6-tetramethyl-, propoxylated (>1 < 4,5 mol PO)
Constituent 1
- Specific details on test material used for the study:
- - Physical description: yellow liquid
- Sample No. UN1760
- Storage temperature: room temperature in the dark
- Test material received: on June 2, 1995
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kohican Valley Rabbitry, Loudonville, Ohio
- Weight at study initiation: 3588 g
- Housing: suspended stainless steel cage
- Diet: PMI Feeds, Inc. Lab Diet, The Richmond Standard, Laboratory Rabbit Diet HF, ad libitum
- Water: tap water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-70 (16 - 21 °C)
- Humidity (%): 40-60
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied 0.1 mL - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: none
Observations on the behaviours of the rabbit were made at 5, 15 and 30 minutes and at 1, 2, 3, 4, 24, 48 and 72 hours after instillation of the test material. The animal was observed twice daily for mortality and moribundity during the study
SCORING SYSTEM: the Draize system
Observations for irritation and ocular lesions were performed at approximately 1, 24, 48 and 72 hours after treatment
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- other: test was terminated after 72h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: test was terminated after 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: test was terminated after 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- other: test was terminated after 72h
- Irritant / corrosive response data:
- The test material elicited ocular effects in the one rabbit following test material administration. Corneal opacity was observed in the one rabbit from the 1-hour interval through the 72-hour interval of the study. An epithelial lesion was observed in the rabbit from the 1-hour interval through the 72-hour interval of the study. The results of the eye examinations using fluorescein indicated significant corneal epithelial effects involving up to approximately 100% of the corneal surface in the rabbit at 24, 48 and 72 hours.
Iridal effects (congestion and swelling, grade 1) were observed in the rabbit from the 1-hour interval through the 72-hour interval of the study. Conjunctival redness, chemosis and discharge were observed in the one rabbit by the 1-hour interval. Draize grades of 2 to 3 were observed in the rabbit at the 1-hour interval, a Draize grade of 3 at the 24-hour interval, and Draize grades of 2 to 3 at the 48 and 72-hour intervals. Conjunctival blanching was noted in the rabbit from the 1-hour interval through the 72-hour interval. Conjunctival petechial hemorrhage was observed in the rabbit from the 24-hour interval through the 72-hour interval. Purulent discharge was noted in the rabbit from 48 hours through 72 hours of the study. - Other effects:
- The one rabbit survived the study period. No abnormal clinical signs were observed in the rabbit during the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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