Registration Dossier
Registration Dossier
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EC number: 205-999-9 | CAS number: 280-57-9
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:
- other: Guideline study, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (obersvation duration 7 days instead of 21 days)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,4-diazabicyclooctane
- EC Number:
- 205-999-9
- EC Name:
- 1,4-diazabicyclooctane
- Cas Number:
- 280-57-9
- Molecular formula:
- C6H12N2
- IUPAC Name:
- 1,4-diazabicyclooctane
- Details on test material:
- - Name of test material (as cited in study report): Triethylendiamine- Physical state: solid - Analytical purity: 98.2 % (NT)- Lot/batch No.: 254439 886, Fluka AG- Stability under test conditions: stable according to re-analysis of melting point (157°C) at April 1, 1987
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoer in 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 13 - 14 weeks
- Weight at study initiation: 2.2 - 2.4 kg
- Housing: single
- Diet: Pelleted standard Kliba 341, Batch 21/86 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland); ad libitum.
- Water: Community tap water from Itingen; ad libitum.
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g per animal was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. - Duration of treatment / exposure:
- One single treatment, the eye was not rinsed.
- Observation period (in vivo):
- 7 days (reading recorded at 1 h, 24 h, 48 h, 72 h and 7 d after application)
- Number of animals or in vitro replicates:
- 2 males, 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp
Eye examinations were made with a slit-lamp 30 SL (C. Zeiss AS, Zuerich / Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Remarks on result:
- other: score 2 after 7 days.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: score 2 after 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: score 2 after 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (3 animals)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Remarks on result:
- other: Score 1 in 2/3 animals and score 0 in 1/3 animals after 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (3 animals)
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Remarks on result:
- other: Score 3 in 2/3 animals; Score 2 in 1/3 animals after 7 days.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: within 7 days
- Remarks on result:
- other: score 2 after 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: score 1 after 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Corneal opacity and partly deformation of the cornea was observed in all rabbits within 1 hour to 7 days after treatment.
- Other effects:
- No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Any other information on results incl. tables
Exposition: Single application to the conjunctival sac of the eyelid; the substance is not washed out |
||||||
Animal |
Reading |
Cornea |
Iris |
Conjunctiva |
|
Additional findings |
|
|
Opacity |
|
Redness |
Chemosis |
|
1 |
1 h |
1 |
0 |
3 |
2 |
Cornea: opacity, whole area; |
2 |
1 h |
1 |
0 |
2 |
2 |
Cornea: opacity, generally; |
3 |
1 h |
1 |
0 |
3 |
2 |
Cornea: opacity, whole area; |
1 |
24 h |
1 |
1 |
3 |
2 |
Cornea: opacity, whole area; |
2 |
24 h |
1 |
1 |
3 |
2 |
Cornea: opacity, whole area, ventral slight deformed; |
3 |
24 h |
1 |
1 |
3 |
2 |
Cornea: opacity, whole area; |
1 |
48 h |
1 |
1 |
3 |
3 |
Cornea: opacity, whole area; |
2 |
48 h |
1 |
1 |
3 |
2 |
Cornea: opacity, whole area, ventral slight deformed; |
3 |
48 h |
2 |
1 |
3 |
2 |
Cornea: opacity, severe, whole area; |
1 |
72 h |
2 |
1 |
3 |
3 |
Cornea: opacity, severe, iris, partly slight darkened; |
2 |
72 h |
1 |
1 |
3 |
2 |
Cornea: opacity, whole area, ventral slight deformed; |
3 |
72 h |
2 |
1 |
3 |
2 |
Cornea: opacity, severe, whole area; |
1 |
7 days |
2 |
1 |
3 |
2 |
Cornea: opacity, severe, iris, partly slight darkened; |
2 |
7 days |
2 |
1 |
3 |
1 |
Cornea: opacity, severe ventral; ventral, clearly visible deformed; |
3 |
7 days |
2 |
0 |
2 |
0 |
Cornea: opacity, severe ventral; |
mean animal 1 |
24 - 72 h |
1.33 |
1.00 |
3.00 |
2.67 |
|
mean animal 2 |
24 - 72 h |
1.00 |
1.00 |
3.00 |
2.00 |
|
mean animal 3 |
24 - 72 h |
1.67 |
1.00 |
3.00 |
2.00 |
|
mean |
24 - 72 h total |
1.25 |
0.75 |
3.00 |
2.22 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU (CLP)
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