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EC number: 932-164-2 | CAS number: -
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 19 August 1991 to 26 August 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Physical state: Clear yellow liquid
- Stability under test conditions: stable
- Storage condition of test material: between 20-30ºC 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: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 17 weeks
- Weight at study initiation: 2825-2910 grams
- Diet (e.g. ad libitum): 100 g per day
- Water (e.g. ad libitum): free access
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated and served as the reference control
- Amount / concentration applied:
- 0.1 mL per animal
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and 7 days after test substance administration
- Number of animals or in vitro replicates:
- three female albino rabbits
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:
- Remarks:
- no irritation at 72 h after treatment
- 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: no irritation at 72 h after treatment
- 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: no irritation at 72 h after treatment
- 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:
- 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:
- 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:
- Remarks on result:
- no indication of irritation
- 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:
- no indication of irritation
- 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:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- 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: no irritation at 72 h after treatment
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
DRAIZE SCORE CALCULATION
Hours/days after application | ||||||
Animal No. | Tissue | 1 hour | 24 hours | 48 hours | 72 hours | 7 days |
732 | Cornea | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | |
Conjunctivae | 6 | 4 | 4 | 2 | 0 | |
Subtotal | 6 | 4 | 4 | 2 | 0 | |
733 | Cornea | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | |
Conjunctivae | 6 | 8 | 6 | 2 | 0 | |
Subtotal | 6 | 8 | 6 | 2 | 0 | |
734 | Cornea | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | |
Conjunctivae | 6 | 8 | 2 | 2 | 0 | |
Subtotal | 6 | 8 | 2 | 2 | 0 | |
TOTAL | 18 | 20 | 12 | 6 | 0 | |
MEAN TOTAL | 6 | 6,7 | 4 | 2 | 0 |
Calculations for EEC classification
Animal No. | Observation time after application | Corneal opacity | Iris lesion | Conjunctivae redness | Conjumctivae chemosis |
732 | 24 hours | 0 | 0 | 2 | 0 |
48 hours | 0 | 0 | 1 | 0 | |
72 hours | 0 | 0 | 1 | 0 | |
Mean value | 0 | 0 | 1,3 | 0 | |
733 | 24 hours | 0 | 0 | 2 | 1 |
48 hours | 0 | 0 | 2 | 1 | |
72 hours | 0 | 0 | 1 | 0 | |
Mean value | 0 | 0 | 1,7 | 0,7 | |
734 | 24 hours | 0 | 0 | 2 | 1 |
48 hours | 0 | 0 | 1 | 0 | |
72 hours | 0 | 0 | 1 | 0 | |
Mean value | 0 | 0 | 1,3 | 0,3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was considered not irritant to the rabbit eye and it need not be labeled as an eye irritant according to GHS and CLP
- Executive summary:
This study was entitled "Acute eye irritation/corrosion study with the substance in the rabbit". This study was carried out in accordance with OECD Guideline No.405, "Acute eye irritation/corrosion.
Under the conditions of this study, the substance resulted in adverse effects on the conjuctivae in all three animals, which had resolved within 7 days. Ocular corrosion was not observed in any of the animals. The substance was considered not irritant to the rabbit eye according to GHS and to CLP
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