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EC number: 609-271-5 | CAS number: 36609-29-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- The study on a similar substance serves as data source for the endpoint study record "CAPA 203 eye irritation: Janssen, 1991 [TARGET]" and the justification for read-across is provided there.
- Adequacy of study:
- key study
- Study period:
- 15th November 1991 to 10th January 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Study serves as data source; read-across justification is found in Target record.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15th November 1991 to 10th January 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- See attached justification
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac, Zeist, The Netherlands.
- Age at study initiation: No information provided.
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: The rabbits were housed individually in stainless steel wire cages KK 102. Sawdust, woodchips or other extraneous material that might produce eye irritation were excluded.
- Diet: 80 g food consisting of a standard laboratory LKK-20 ad libitum.
- Water: Water available ad libitum
- Acclimation period: 11 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 22°C
- Humidity 52 - 70%
- Air changes: Approximately 16 air changes per hour.
- Photoperiod: 12 hours light/12 hours dark. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each rabbit acted as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- After the acclimatisation period, both eyes of each rabbit were examined with the aid of a slit-lamp. Only those rabbits without eye defects or signs of irritation were used. A quantity of 0.1 mL CAPA 203 was placed in the conjunctival sac of the left eye by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was placed. The lids were then gently held together for a short period and the rabbit was released. The other eye remained untreated and served as a control. Readings of reactions were made in all three rabbits at 1, 24, 48 and 72 hours after treatment. Scoring of the irritation was performed according to the grades given in the Draize method.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed in any of the three rabbits after instillation of 0.1 mL CAPA 203.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were no signs of irritation in any rabbit at any timepoint in this study. The read-across substance CAPA 203 was not shown to be an eye irritant and does not therefore require classification for eye irritation according to the CLP Regulation. A similar lack of eye irritation potential is therefore predicted for CAPA 2047A
- Executive summary:
A study to assess the primary eye irritation of the read-across substance CAPA 203 (2 -oxepanone, polymer with 1,4 -hexanediol) in rabbits was conducted in accordance with OECD Guideline 405 and GLP. 0.1 mL CAPA 203 was instilled into the conjunctival sac of one eye of each of three male rabbits. T he eyes of the rabbits were examined and ocular reactions were graded at intervals up to and including 72 hours after treatment. Following the observation period, there were no signs of irritation observed in the three rabbits. A similar lack of eye irritation potential is therefore predicted for CAPA 2047A
Individual irritation scores
Animal # |
Finding |
Pretest |
Hours (h) after treatment |
Mean (24 -72h) |
||||||
1h |
24h |
48h |
72h |
|||||||
1 |
Cornea |
Opacity Area involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 |
|||
2 |
Cornea |
Opacity Area involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 |
|||
3 |
Cornea |
Opacity Area involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 |
|||
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-Oxepanone, polymer with 1,4-butanediol
- Cas Number:
- 31831-53-5
- IUPAC Name:
- 2-Oxepanone, polymer with 1,4-butanediol
- Reference substance name:
- CAPA 2043
- IUPAC Name:
- CAPA 2043
- Reference substance name:
- Reference substance 001
- EC Number:
- 932-682-9
- Cas Number:
- 31831-53-5
- Reference substance name:
- 2-Oxepanone, polymer with 1,4-butanediol
- EC Number:
- 608-670-1
- Cas Number:
- 31831-53-5
- Molecular formula:
- l(HO(CH2)5CO)-O(CH2)4O-(CO(CH2)5OH)m
- IUPAC Name:
- 2-Oxepanone, polymer with 1,4-butanediol
- Test material form:
- other: liquid.
- Details on test material:
- - Name of test material (as cited in study report): Capa 2043
- Physical state: Colourless liquid.
- Analytical purity: 97%
- Lot/batch No.: WAC000392
- Expiration date of the lot/batch: 17th February 2014
- Storage condition of test material: Stored in the dark at room temperature.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- CAPA 203 (2-oxepanone, polymer with 1,4-butanediol)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac, Zeist, The Netherlands.
- Age at study initiation: No information provided.
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: The rabbits were housed individually in stainless steel wire cages KK 102. Sawdust, woodchips or other extraneous material that might produce eye irritation were excluded.
- Diet: 80 g food consisting of a standard laboratory LKK-20 ad libitum.
- Water: Water available ad libitum
- Acclimation period: 11 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 22°C
- Humidity 52 - 70%
- Air changes: Approximately 16 air changes per hour.
- Photoperiod: 12 hours light/12 hours dark.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each rabbit acted as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- After the acclimatisation period, both eyes of each rabbit were examined with the aid of a slit-lamp. Only those rabbits without eye defects or signs of irritation were used. A quantity of 0.1 mL CAPA 203 was placed in the conjunctival sac of the left eye by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was placed. The lids were then gently held together for a short period and the rabbit was released. The other eye remained untreated and served as a control. Readings of reactions were made in all three rabbits at 1, 24, 48 and 72 hours after treatment. Scoring of the irritation was performed according to the grades given in the Draize method.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed in any of the three rabbits after instillation of 0.1 mL CAPA 203.
Any other information on results incl. tables
Individual irritation scores
Animal # |
Finding |
Pretest |
Hours (h) after treatment |
Mean (24 -72h) |
||||||
1h |
24h |
48h |
72h |
|||||||
1 |
Cornea |
Opacity Area involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 |
|||
2 |
Cornea |
Opacity Area involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 |
|||
3 |
Cornea |
Opacity Area involved |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
Redness Chemosis Discharge |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 |
|||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were no signs of irritation in any rabbit at any timepoint in this study. CAPA 203 was not shown to be an eye irritant and does not therefore require classification for eye irritation according to the CLP Regulation.
- Executive summary:
A study to assess the primary eye irritation of CAPA 203 (2 -oxepanone, polymer with 1,4 -hexanediol) in rabbits was conducted in accordance with OECD Guideline 405 and GLP. 0.1 mL CAPA 203 was instilled into the conjunctival sac of one eye of each of three male rabbits. T he eyes of the rabbits were examined and ocular reactions were graded at intervals up to and including 72 hours after treatment. Following the observation period, there were no signs of irritation observed in the three rabbits.
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