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EC number: 427-370-1 | CAS number: 164288-56-6
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: similar to the OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- -
- EC Number:
- 427-370-1
- EC Name:
- -
- Cas Number:
- 164288-56-6
- Molecular formula:
- C21H44N3O3Cl
- IUPAC Name:
- {[(2-hydroxyethyl)carbamoyl]methyl}dimethyl(3-octadecanamidopropyl)azanium chloride
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
Constituent 1
impurity 1
impurity 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Species, strain, supplier : New Zealand albino rabbit, Charles RIVER (76410 Saint-Aubin Les-Elbeuf, France).
- Reason for species selection : the New-Zealand albino rabbit is the animal traditionally used for the evaluation of irritant potential of products and is the animal chosen by the regulatory authorities,
- Number, sex: 3 males
- Average weight: 2.5 kg
- Identification: auricular ring
- Accllimatization: at least 5 days
- Housing, diet: environmental conditions and controls in accordance with the requirements of the 86/609/EEC guideline (individual housing on floor grid). Complete pelleted rabbit maintenance diet Energie H326, COFNA (37000 - Tours, France).
Test system
- Vehicle:
- water
- Amount / concentration applied:
- During this test, the product was used adjusted to 5 % (w/w) in active matter.
- Duration of treatment / exposure:
- see study design
- Observation period (in vivo):
- up to 7 days after instillation
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- This test is realized on 3 rabbits with healthy defect free eyes.
The product is applied directly in the everted lower lid of the right and left eyes of three rabbits at the dose of 0.1 mL by eye and according to the following procedure:
- after instillation, the lids are held together for about 10 seconds in order to prevent loss of the product.
- 30 seconds after instillation of the product, the right eye of the three animaIs is rinsed by a gentle spray of distiiled water.
- the left eye is not rinsed.
After a one hour period of contention, the animals are returned to their individual cage.
The light and the left eyes of the rabbits are examined 1 hour, then 1, 2, 3, 4 and 7 days after instillation.
The criteria of evaluation of ocular irritation and scoring ofthe product are defined in appendix 1.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 40
- Max. score:
- 40
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 40
- Max. score:
- 40
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 40
- Max. score:
- 40
- Reversibility:
- fully reversible within: 7 Days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 40
- Max. score:
- 40
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 30
- Max. score:
- 40
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 30
- Max. score:
- 40
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0
- Reversibility:
- fully reversible within: 7 Days
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 16
- Max. score:
- 18
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other:
- Score:
- ca. 18
- Max. score:
- 18
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- ca. 16
- Max. score:
- 18
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 16
- Max. score:
- 16
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 16
- Max. score:
- 16
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 16
- Max. score:
- 16
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 10
- Max. score:
- 16
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 16
- Max. score:
- 16
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 12
- Max. score:
- 16
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- ca. 0
- Remarks on result:
- not measured/tested
- Remarks:
- No observations were done at 72 h time point
Any other information on results incl. tables
The results presented are related to the application without rinse.
score after 48 hours
animal conjunctiva iris cornea 1 10 10 40 2 16 5 30 3 12 5 30
after 72 hours
animal conjunctiva iris cornea 1 10 10 30 2 14 5 20 3 10 5 20
after 7 days
animal conjunctiva iris cornea 1 6 5 10 2 4 5 5 3 4 5 5
Applicant's summary and conclusion
- Interpretation of results:
- other: severly irritant
- Remarks:
- Criteria used for interpretation of results: other: in accordance with the Officiai Method of the French Republic (J.O. of July 10, 1992).
- Conclusions:
- Considering the ocular irritation indices deterrnined under the experimental conditions adopted, the test item is concluded severely irritant to eye and subsequently the test item is:
• severely irritant to eyes : OlMax = 64.3 at 24 hours when its instillation is not followed by a rinse. - Executive summary:
The aim of this study was to assess the ocumar irritanting potential of the test item in the rabbit.
The study design is similar to the OECD guideline n°405.
This test is realized on 3 rabbits with healthy defect free eyes. The product is applied directly in the everted lower lid of the right and left eyes of three rabbits at the dose of 0.1 mL by eye and according to the following procedure:
- after instillation, the lids are held together for about 10 seconds in order to prevent loss of the product.
- 30 seconds after instillation of the product, the right eye of the three animaIs is rinsed by a gentle spray of distiiled water.
- the left eye is not rinsed. After a one hour period of contention, the animals are returned to their individual cage. The light and the left eyes of the rabbits are examined 1 hour, then 1, 2, 3, 4 and 7 days after instillation.
The criteria of evaluation of ocular irritation and scoring ofthe product are defined in appendix 1.
Considering the ocular irritation indices deterrnined under the experimental conditions adopted, the test item is:
• severely irritant to eyes : OlMax = 64.3 at 24 hours when its instillation is not followed by a rinse.
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