Registration Dossier
Registration Dossier
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EC number: 205-465-5 | CAS number: 141-17-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Oct 1997 - 30 Oct 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted generally according to an accepted and published method. Experimental documentation was limited but adequate for the purposes of this summary.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
- Reference Type:
- secondary source
- Title:
- EPA High Production Volume Chemical Challenge Program CAS 141-17-3 adipic acid, bis[2-(2-butoxyethoxy)ethyl] ester
- Author:
- US EPA
- Year:
- 2 011
- Bibliographic source:
- High Production Volume Chemical Challenge Program
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- EC Number:
- 205-465-5
- EC Name:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- Cas Number:
- 141-17-3
- Molecular formula:
- C22H42O8
- IUPAC Name:
- bis(2-(2-butoxyethoxy)ethyl) adipate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Davidson Mill Breeding Laboratories, Jamesburg, New Jersey, USA- Ag at arrival: 3 months- Fasting period before study: none- Housing: stainless steel cages- Diet: Lab Diet Certified Rabbit Diet #5322, ad libitum- Water: ad libitum- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 - 24 (65 - 75 °F)- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: To: 27 Oct 1997 - 30 Oct 1997
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye remained untreated and served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Single administration without washing
- Observation period (in vivo):
- 72 hoursReading time points: 1, 24, 48, and 72 h after treatment
- Number of animals or in vitro replicates:
- 6 (3 male, 3 female)
- Details on study design:
- SCORING SYSTEM: Draize Scoring SystemTOOL USED TO ASSESS SCORE: fluorescein, hand-held ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
Any other information on results incl. tables
Table 1: Primary ocular irritiation in rabbits - Summary
Rabbit number |
Bodyweight [kg] |
Reading time [h] |
Cornea |
Iris |
Conjunctivae |
|||
Score |
Area |
Redness |
Chemosis |
Discharge |
||||
1 |
Init: 1.96 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.86 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Init: 1.97 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.87 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Init: 1.86 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.76 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
Init: 1.99 |
1 |
0 |
0 |
0 |
1 |
0 |
1 |
- |
24 |
0 |
0 |
0 |
1 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.89 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
Init: 1.88 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.79 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
Init: 2.0 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
- |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
|
- |
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Term: 1.96 |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- CLP: not classifiedDSD: not classified
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