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EC number: 938-645-3 | CAS number: 1689515-39-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- In vivo study, the study was conducted before validated in vitro methods were available.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 15, 2001 - July 5, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amphoacetates C12
- Cas Number:
- 68608-66-2
- IUPAC Name:
- Amphoacetates C12
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Oxidane
- Test material form:
- other: aqueous solution
- Details on test material:
- Name of the test material (as cited in the report): Miranol H2M CONC
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A., Como, Italy
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2.4 - 2.8 kg
- Housing:
The animals were individually housed in stainless steel cages measuring 48x63x41 cm and equipped with grid floors. Cages were suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary.
- Diet (e.g. ad libitum): ad libitum (pelleted laboratory diet from Altromin MSK, Altromin, D-32770 Lage, Postfach 1120, Germany)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum period of 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 21 °C
- Humidity (%): 45 to 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye of each animal remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration (if solution): not applicable, the aqueous solution was tested as such - Duration of treatment / exposure:
- Not applicable (the eyes were not rinsed)
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: not applicable
SCORING SYSTEM: in accordance with OECD 405
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: solid content of the test material: 50%
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: solid content of the test material: 50%
- Irritant / corrosive response data:
- See section "Any other information on results incl. tables"
Any other information on results incl. tables
| Scores for corneal opacity | |||||
| CORNEA | 1h | 24h | 48h | 72h | Individual mean scores (24, 48 and 72h) |
| Rabbit 1 | 1 | 1 | 1 | 1 | 1.0 |
| Rabbit 2 | 0 | 1 | 1 | 2 | 1.3 |
| Rabbit 3 | 0 | 1 | 1 | 2 | 1.3 |
| Scores for iris lesion | |||||
| IRIS | 1h | 24h | 48h | 72h | Individual mean scores (24, 48 and 72h) |
| Rabbit 1 | 1 | 0 | 0 | 0 | 0.0 |
| Rabbit 2 | 1 | 0 | 0 | 0 | 0.0 |
| Rabbit 3 | 1 | 0 | 0 | 0 | 0.0 |
| Scores for Redness and Chemosis of conjunctivae | ||||||
| CONJUNCTIVAE | 1h | 24h | 48h | 72h | Individual mean scores (24, 48 and 72h) |
|
| Rabbit 1 | Redness | 3 | 1 | 1 | 2 | 1.3 |
| Chemosis | 2 | 1 | 1 | 1 | 1.0 | |
| Rabbit 2 | Redness | 2 | 2 | 2 | 1 | 1.7 |
| Chemosis | 2 | 1 | 2 | 1 | 1.3 | |
| Rabbit 3 | Redness | 3 | 2 | 2 | 2 | 2.0 |
| Chemosis | 3 | 1 | 1 | 1 | 1.0 | |
Other information:
- The animals had a normal weight gain during the 14 days(0.1 -0.3 kg)
- No indication of systemic effects
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The eye irritation potential of Miranol H2M CONC (amphoacetates C12) has been investigated according to OECD 405 and GLP. On the basis of the obtained results, the test material (solid content 50%) is classified as Irritating to eyes (Category 2) according to the criteria of the CLP Regulation.
- Executive summary:
The eye irritation potential of Miranol H2M CONC (amphoacetates C12) has been investigated according to OECD 405 and GLP. The test material was tested as an aqueous solution at 50% solids for acute ocular irritation in 3 female New-Zealand White rabbits. The test material, was instillated as such in a single dose of 0.1 ml into the conjunctival sac of the right eye of each animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed 1, 24, 48 and 72 hours after the instillation. Slight corneal opacity (grade 1) was observed at 1 hour after instillation in one animal, then between day 1 and 7 in all animals (grade 1 or 2). Iris inflammation (grade 1) was only noted at 1 hour. The mean scores (24-48-72 hours) calculated for each animal were 1.0 - 1.3 - 1.3 for corneal opacity, and 0.0 - 0.0 - 0.0 for iritis. Conjunctival redness and chemosis (grades 2 or 3) was observed in all three animals at 1 hour after instillation, and persisted until 72 hours (grade 1 or 2). These reactions were no longer present at day 7. The mean scores (24-48-72 hours) calculated for each animal were 1.3 - 1.7 - 2.0 for conjunctival redness, and 1.0 - 1.3 - 1.0 for chemosis. The test material (solid content 50%) is classified as irritating to eyes (Category 2) according to the criteria of the CLP Regulation.
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