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EC number: 242-893-1 | CAS number: 19223-55-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 May 1995 - 28 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxooctyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C16H34N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxooctyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxodecyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C18H38N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxodecyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide
- EC Number:
- 242-893-1
- EC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide
- Cas Number:
- 19223-55-3
- Molecular formula:
- C20H42N2O5S
- IUPAC Name:
- N-[3-(dodecanoylamino)propyl]-2-hydroxy-N,N-dimethyl-3-sulfopropan-1-aminium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxotetradecyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C22H46N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxotetradecyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxohexadecyl)amino]propyl]ammonium hydroxide
- Molecular formula:
- C24H50N2O5S
- IUPAC Name:
- (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxohexadecyl)amino]propyl]ammonium hydroxide
- Reference substance name:
- [2-hydroxy-3-sulphopropyl]dimethyl[3-[(1-oxooctadecyl)amino]propyl]ammonium hydroxide
- EC Number:
- 264-390-6
- EC Name:
- [2-hydroxy-3-sulphopropyl]dimethyl[3-[(1-oxooctadecyl)amino]propyl]ammonium hydroxide
- Cas Number:
- 63663-12-7
- Molecular formula:
- C26H54N2O5S
- IUPAC Name:
- 2-hydroxy-N,N-dimethyl-N-[3-(stearoylamino)propyl]-3-sulfopropan-1-aminium hydroxide
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- 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:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Reference substance name:
- Disodium 2-hydroxypropane-1,3-disulfonate
- Molecular formula:
- C3H8O7S2.Na2
- IUPAC Name:
- Disodium 2-hydroxypropane-1,3-disulfonate
- Reference substance name:
- Sodium (±)-2,3-dihydroxypropanesulphonate
- EC Number:
- 252-542-4
- EC Name:
- Sodium (±)-2,3-dihydroxypropanesulphonate
- Cas Number:
- 35396-47-5
- Molecular formula:
- C3H8O5S.Na
- IUPAC Name:
- sodium (±)-2,3-dihydroxypropanesulphonate
- Reference substance name:
- Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
- EC Number:
- 930-947-3
- IUPAC Name:
- Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: B&K Universal G.J., Barcelona, Spain
- Gender: male
- Age upon arrival at test facility: approx. 9-10 weeks
- Weight at study initiation: 2.2 - 2.4 kg
- Housing: individually in stainless steel cages (48 x 59 x 37 cm) with grilled floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 50-85
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 30 May 1995 To: 27 June 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- ADMINISTRATION OF TEST SUBSTANCE
- Location: into the right conjunctival sac, made accessible by carefully pulling lower lid down
- Procedure immediately after instillation: lids of treated eye held closed for approx. 10 sec
OBSERVATION TIMEPOINTS: 1, 24, 48, 72 hours, and on day 7, 14 and 21 after instillation
SCORING SYSTEM: Draize scoring on conjunctivae, iris and cornea (as per OECD test guideline 405 recommendations)
TOOL USED TO ASSESS SCORE:
- Use of hand-slit lamp / biomicroscope: not specified
- Use of fluorescein: for all observations except 1 h after instillation
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:
- 1
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- See table below
Any other information on results incl. tables
Animal number |
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
Individual score* |
Cornea |
||||||||
299 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
289 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
190 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
|
Mean score |
1 |
||||||
Iris |
||||||||
299 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
289 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
190 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
|
Mean score |
1 |
||||||
Conjunctival redness |
||||||||
299 |
3 |
3 |
3 |
2 |
1 |
0 |
0 |
2.67 |
289 |
2 |
3 |
3 |
3 |
2 |
1 |
0 |
3 |
190 |
2 |
3 |
3 |
2 |
1 |
1 |
0 |
2.67 |
|
Mean score |
2.78 |
||||||
Conjunctival chemosis |
||||||||
299 |
2 |
2 |
1 |
1 |
1 |
1 |
0 |
1.33 |
289 |
3 |
3 |
2 |
2 |
1 |
0 |
0 |
2.33 |
190 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
2 |
|
Mean score |
1.89 |
||||||
* For the 24, 48 and 72 h timepoints
Details of eye irritation scores (according to Draize)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Cocamidopropyl hydroxysultaine, as a 41.5% solution, is considered a severe eye irritant.
- Executive summary:
Cocamidopropyl hydroxysultaine, as a 41.5% solution (Betadet SHR), has been tested for acute eye irritation on 3 male New Zealand White rabbits, in accordance with OECD test guideline 405, and in compliance with Good Laboratory Practice.
The test article was applied as such in a single conjunctival dose of 0.1 mL in the right eye of each rabbit, the untreated eye being used as a control. Ocular examinations, grading cornea, iris and conjunctiva (redness and chemosis) reactions, were performed at 1, 24, 48, 72 hours, and on day 7, 14 and 21 after instillation of the test article.
Within the first hour following instillation, the test article induced conjunctival abnormalities including hyperhaemia ranging from grade 2 (diffuse, crimson color, individual vessels not easily discernible) to grade 3 (diffuse, deep red color), edema ranging from grade 2 to 3, redness of the bulbar conjunctivae, lacrimation and congestion and injection of the iris (grade 1).
At the observations carried out 24, 48 and 72 hours after instillation, all rabbits showed hyperhaemia ranging from grade 2 to grade 3, chemosis from grade 1 to grade 3, redness of the bulbar conjunctivae, lacrimation and congestion and injection of the iris (grade 1). Corneal opacity (grade 1) was also observed in all animals.
Some of the corneal and conjunctival abnormalities persisted up to day 14 after instillation inclusive. Conjunctival chemosis was still observed in one of the rabbits 21 days after instillation of the test article.
Based on these results, Cocamidopropyl hydroxysultaine, as a 41.5% solution, was considered a severe eye irritant.
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