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Registration Dossier
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EC number: 939-457-4 | CAS number: 1469983-50-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 May 1995 - 27 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 404 (Acute Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: accredited supplier
- Gender: male
- Age upon arrival at test facility: approx. 9-10 weeks
- Weight at study initiation: 2.3 - 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: 16 June 1995
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after the end of exposure period (examinations at 60 min, 24, 48 and 72 h)
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: substance placed on 2.5 x 2.5 cm surgical gauze, patch held close to the skin using adhesive tape strips, strip of gauze wrapped around trunk of the animal using additional adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): once patch removed, remainder of product eliminated with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See table below
Any other information on results incl. tables
Animal number |
Erythema / Eschar |
Edema |
||||||||
60 min |
24 h |
48 h |
72 h |
Individual score* |
60 min |
24 h |
48 h |
72 h |
Individual score* |
|
146 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
912 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
913 |
1 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
|
Mean score |
0.22 |
Mean score |
0 |
||||||
* For the 24, 48 and 72 h timepoints
Details of skin irritation scores (according to Draize)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Cocamidopropyl hydroxysultaine, as a 41.5% solution, is not considered a skin irritant.
- Executive summary:
Cocamidopropyl hydroxysultaine, as a 41.5% solution, has been tested for acute skin irritation on 3 male New Zealand White rabbits, in accordance with OECD test guideline 404, and in compliance with Good Laboratory Practice.
The test article was applied as such in a single dermal dose of 0.5 mL to a shaved 6 cm² area of the intact skin, for 4 hours under a semi-occlusive dressing. Cutaneous examinations were performed at 1, 24, 48 and 72 hours after the dressing removal.
One hour after dressing removal, very slight erythema (grade 1) was observed in all animals. At examinations carried out 24 and 48 h after dressing removal, only one animal showed very slight erythema (grade 1).
No cutaneous reactions were observed in any of the animals at 72 hours after dressing removal.
Mean scores for erythema and edema (24, 48 and 72 hours after treatment) were 0.22 and 0.00, respectively.
Based on these results, Cocamidopropyl hydroxysultaine, as a 41.5% solution, was not considered a skin irritant.
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