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EC number: 225-716-2 | CAS number: 5026-74-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 19 -may 26 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according draft of U.S. guideline and before GLP was in place. Reliable observations and reliable report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- Based on the draft guideline 163.81-4, FR 43, 163 of August 22, 1978. No difference to the final guideline identified.
- GLP compliance:
- no
- Remarks:
- study performed before GLP was in place.
Test material
- Reference substance name:
- p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline
- EC Number:
- 225-716-2
- EC Name:
- p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline
- Cas Number:
- 5026-74-4
- Molecular formula:
- C15H19NO4
- IUPAC Name:
- 4-[(oxiran-2-yl)methoxy]-N,N-bis[(oxiran-2-yl)methyl]aniline
- Test material form:
- liquid: viscous
- Details on test material:
- - Substance type: organic
- Physical state: liquid
- Storage condition of test material: In refrigerator (2-8°C) in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Ltd, Sisseln, Switzerland
- Sex: male
- Weight at study initiation: 2-3 kg
- Housing: Individual housing in metal cages, numbered by ear tags
- Diet (e.g. ad libitum): ad libitum access to standard rabbit food, NAFAG No. 814
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 deg C
- Humidity (%): 55 +/-10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hours light per day
IN-LIFE DATES: From: To: May 19, 1980 to May 26, 1980
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye was treated, the right eye was untreated and used as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml inserted into the conjunctival sac of the left eye
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 3 animals: unrinsed, 3 animals: eyes rinsed about 30 sec after instillation
- Observation period (in vivo):
- 7 days, examinatinos on day 1, 2, 3, 4 and 7
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 animals the eye was washed with physiological saline, in 3 animals the eye was not washed
- Time after start of exposure: 30 sec
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Please refer to the table below in "Any other information on results incl. tables" field.
- Basis:
- other: See additional information
- Remarks:
- Any other information on results
- Time point:
- other: See additional information
- Reversibility:
- other: Please refer to the table below in "Any other information on results incl. tables" field.
- Remarks on result:
- other: Please refer to the table below in "Any other information on results incl. tables" field.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 80
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.7
- Max. score:
- 80
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 7.3
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 6.7
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.667
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- slightly irritant, see table
Any other information on results incl. tables
| days after exposure | mean reaction score (3 animals) | |||||||||
| unrinsed eyes | rinsed eyes | |||||||||
| cornea | iris | conjunctiva | cornea | iris | conjunctiva | |||||
| Redness | Chemosis | Discharge | Redness | Chemosis | Discharge | |||||
| 1 | 0.33 | 0 | 1.66 | 1.33 | 0.66 | 0 | 0 | 1 | 0.33 | 0.33 |
| 2 | 0.33 | 0 | 1.33 | 1 | 1 | 0 | 0 | 0.66 | 0.33 | 0.33 |
| 3 | 0 | 0 | 0.66 | 0.66 | 0.66 | 0 | 0 | 0 | 0 | 0 |
| 4 | 0 | 0 | 0.66 | 0.66 | 0.33 | 0 | 0 | 0 | 0 | 0 |
| 7 | 0 | 0 | 0.66 | 0.66 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not an eye irritant according to Regulation (EC) No 1272/2008.
- Executive summary:
The eye irritancy was investigated in rabbits. The effect on the left eye of each three rabbits was scored after instillation of 0.1 ml of test material, either rinsed after 30 seconds of exposure or unrinsed. The right eyes were left untreated and used as control. The observation period was 7 days. There were slight effects on the cornea and iris visible for 2 days or less. The conjunctiva of an unrinsed eye of one rabbit remained reddened until the end of the observation period, all other animals did not show an effect on day 3 and thereafter.
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