Registration Dossier
Registration Dossier
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EC number: 405-820-6 | CAS number: 30025-38-8
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:
- other: GLP guideline study - original study report available
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 405-820-6
- EC Name:
- -
- Cas Number:
- 30025-38-8
- Molecular formula:
- C8H18O3
- IUPAC Name:
- reaction mass of 5-methyl-4,7-dioxa-2-nonanol and 6-methyl-4,7-dioxa-2-nonanol
- Details on test material:
- - Name of test material (as cited in study report): Dipropylene Glycol Monoethyl Ether; DPGEE
- Substance type: Glycol ether
- Physical state: Colourless liquid
- Lot/batch No. GOHC laboratory Sample No. 1030, Oil Stock Ref. No. 09977, 134/109
- Expiration date of the lot/batch: Not specified
- Stability under test conditions: Not specified.
- Storage condition of test material: At ambient temperature in brown screw-capped bottle.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: C&J Morton, Stansted, UK
- Age at study initiation: >3 months
- Weight at study initiation: 2.49-2.77 kg
- Housing: Individually in suspended, mesh-floored cages
- Diet (e.g. ad libitum): Commercially available pelleted standard rabbit diet ad libitum
- Water (e.g. ad libitum): mains supply, ad libitum
- Acclimation period: 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (10-25)
- Humidity (%): 50 (40-75)
- Air changes (per hr): 12 (no recirculation)
- Photoperiod (hrs dark / hrs light): 10/14
IN-LIFE DATES: From: 1985-10-28 to 1985-11-04
- Weight at study initiation: 2.49-2.77 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml undiluted
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 8 Days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
SCORING SYSTEM:
Pain (not a criterion of OECD test)
No response 0
Few blinks of eye 1
Blinks, tries to open eye but closed by reflex 2
Eye held shut, may rub eye 3
Holds eye shut vigorously; may squeal 4
Holds eye shut vigorously; may squeal, claw at eye and try to escape 5
Cornea:
No ulceration or opacity 0
Scattered diffuse opacity - iris clearly visible 1
Easily discernible translucent areas 2
Nacreous areas, details of iris not visible, size of pupil barely discernible 3
Complete corneal opacity, iris not discernible, pannus formation or ulceration 4
Iris:
Normal 0
Markedly deepened folds, congestion, swelling, moderate circumcorneal injection 1
No reaction to light, haemorrhage, gross destruction 2
Conjunctivae:
Redness
Vessels normal 0
Some vessels injected 1
Diffuse, crimson-red, individual vessels not discernible 2
Diffuse, beefy-red 3.
Chemosis
No swelling 0
Any swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
TOOL USED TO ASSESS SCORE: hand-pencil beam lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
Any other information on results incl. tables
Mean of measurements at 24, 48, 72 hours
|
Animal 1 |
Animal 2 |
Animal 3 |
Classification under 67/548 |
Classification under 1272/2008 |
Corneal effects |
1 |
0.3 |
0.3 |
No |
No |
Iritis |
0 |
0 |
0 |
No |
No |
Conjunctival effects |
1.7 |
1.7 |
1.0 |
No |
No |
Chemosis |
1.0 |
0.7 |
0.3 |
No |
No |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Mean values over the evaluation points 24, 48 and 72 h did not equal or exceed the limit values for classifying the test material as irritant or corrosive to the eye.
- Executive summary:
In this well conducted OECD 405 study mean scores for each of the ocular irritancy measures (corneal opacity, iris lesions, conjunctival redness and chemosis) were recorded. Dipropylene glycol monoethyl ether was found to cause mild but reversible irritation. The level of response was not enough to trigger classification for eye irritation either under directive 67/548 or under regulation 1272/2008
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