Registration Dossier
Registration Dossier
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EC number: 283-829-2 | CAS number: 84731-70-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-04-07 to 2009-09-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate
- EC Number:
- 283-829-2
- EC Name:
- Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate
- Cas Number:
- 84731-70-4
- Molecular formula:
- C24H44O4
- IUPAC Name:
- 1,4-bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 20090226
Purity: 99.38%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Orient Bio, Ltd, 143-1 Sangdaewon-Dong, Jungwon-Gu, Seongnam-Si, Gyeonggi-Do, Korea
- Age at study initiation: 2 months
- Weight at study initiation: 1900 to 2079 g; the 3 rabbits selected for the study ranged from 2193 to 2445.
- Housing: During acclimation, quarantine and the test period, rabbits were hosued individually in 3 lines x 4 ros of stainless acges (590 mm w x 460 mm l x 360 mm h).
- Diet (e.g. ad libitum): Pelleted food was obtained from Purina Korea and was available ad libitum
- Water (e.g. ad libitum): Municipal tap water was available ad libitum following uv irradiatio and filtration.
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 20 times/h
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle with a light intensity of 150 - 300 lux.
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each animal remained untreated as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72 hrs (observations at 1 hr, 24 hrs, 48 hrs, 72 hrs after application)
- Number of animals or in vitro replicates:
- 3 male
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no positive reponse in any animal at any time point.
Observations performed at 1, 24, 48 and 72 h after the application elucidated no irritative response on cornea, iris or conjunctiva. The acute eye irritation index of the test item was calculated to be 0. - Other effects:
- Clinical signs and mortality
There were no deaths or detecable clinical signs in any test animals which coud be attributed to the test item.
Body weight
No treatment-related body weight changes were observed.
Any other information on results incl. tables
Results of eye reaction
Animal No. |
|
1 |
2 |
3 |
Cornea opacity |
1 hour |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
|
Iris |
1 hour |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
|
Conjunctiva redness |
1 hour |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
|
Chemosis |
1 hour |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
|
48 hours |
0 |
0 |
0 |
|
72 hours |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The test substance was assessed for eye irritation in three healthy New Zealand white rabbits. No clinical sings, body weight changes, body weight changes, dead animals or abnormal eye reaction considered to be due to test item were observed. The test item was considered to be non-irritating to eyes.
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