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EC number: 500-092-7 | CAS number: 36890-68-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25/11/1991 - 28/11/1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
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:
- ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol
- EC Number:
- 500-092-7
- EC Name:
- ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol
- Cas Number:
- 36890-68-3
- Molecular formula:
- C6H10O2x.C4H8O3
- IUPAC Name:
- 2-oxepanone, polymer with 2,2'-oxybis[ethanol]
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Test material form:
- liquid
Constituent 1
additive 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Test animals were obtained from Harlan Olac, Zeist, The Netherlands.
- Weight at study initiation: 1.8 – 2.2 kg
- Housing: Rabbits were individually housed in stainless steel wire cages KK 102. Sawdust, woodchips or other extraneous material that might produce eye irritation were excluded
- Diet and Water - Test animals received 80g food (a standard laboratory diet LKK-20, Hope farms, Woerden, The Netherlands) per day during the acclimatization period of 11 days. During the experiment they had free access to food and water
- Acclimation period: A period of 11 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19- 20°C
- Humidity: 52-72%
- Air changes :16 air changes per hr
- Photoperiod: Artificial light from 7a.m till 7 p.m.
- Radio sound on 7 a.m. till 7 p.m.
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:
- Not applicable, the eyes were not rinsed after the instillation of the test item.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after treatment
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- - 0.1 mL of test substance was instilled in the left eye of test animals
- Washing : The eyes were not rinsed after application of the test material.
SCORING SYSTEM: Draize scale, according to OECD TG 405
TOOL USED TO ASSESS SCORE: Hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1hr after treatment
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- animal: #1, #2, #3
- Time point:
- other: 1 hr after treatment
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24hrs
- Remarks:
- Lacrimation and with addition a viscous clear liquid in rabbits number 2 and 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test substance did not cause corneal or iridial effects during the study. Minimal conjunctiva redness was noticed 1 hr after application of the test material in all animals but this effect disappeared after 24hrs. Similarly, conjunctiva discharge (lacrimation with in addition a viscous clear liquid in rabbits no’s 2 and 3) was noticed 1 hr after application of the test material in all animals but this effect disappeared after 24hrs
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Scores of the irritation reactions after application of 0.1ml CAPA 304 to the eye of three rabbits
Animal No. |
Region of the eye |
Pretest |
Hours (h) after treatment |
Meana |
||||
1h |
24h |
48h |
72h |
|||||
1 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Area involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva |
Redness |
0 |
1 |
0 |
0 |
0 |
0 0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
Discharge |
0 |
1b |
0 |
0 |
0 |
|||
2 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
|
Area involved |
0 |
0 |
0 |
0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva |
Redness |
0 |
1 |
0 |
0 |
0 |
0 0 |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
|
Discharge |
0 |
1b |
0 |
0 |
0 |
||
3 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0
|
|
Area involved |
0 |
0 |
0 |
0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva |
Redness |
0 |
1 |
0 |
0 |
0 |
0 0 |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
|
Discharge |
0 |
1b |
0 |
0 |
0 |
||
a Mean of 24, 48 and 72 hour readings
b Lacrimation with in addition a viscous clear liquid in rabbits number 2 and 3
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, CAPA 304 induced no significant eye irritation to test animals. The test substance is not classified as irritating to the eyes according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP)
- Executive summary:
In this eye irritation study performed according to the OECD guideline No. 405 and in compliance with GLP, 0.1 mL of undiluted test material was instilled into the left eye of 3 New Zealand White Male Rabbits. The eyes were not rinsed after the instillation of the test item. The right eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours after dosing under a standard light source. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
No corneal or iridial effects were noted during the study. Very slight irritation of the conjunctiva and lacrimation was observed in 3 rabbits 1 hour after instillation of 0.1 ml CAPA 304 in their left eye. This effect however disappeared after 24hrs. The calculated mean score for redness, discharge, chemosis, iris and corneal lesions for all animals at 24, 48 and 72h after treatments was 0. One hour after instillation of the test material; discharge of any amount different from normal (does not include small amount observed in inner canthus of normal animals) was noticed in all animals. Lacrimation and with addition a viscous clear liquid in rabbits number 2 and 3. The effects observed 1hr after instillation was test material disappeared after24 hours.
Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP)
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